Accepted Manuscript

Comparison of Staples Versus Subcuticular Suture in Class III Obese Women

Undergoing Cesarean: A Randomized Controlled Trial

Mary N. Zaki, MD, Deborah A. Wing, MD, MBA, Jennifer A. McNulty, MD

PII: S0002-9378(18)30155-8
DOI: 10.1016/j.ajog.2018.02.011
Reference: YMOB 12084

To appear in: American Journal of Obstetrics and Gynecology

Received Date: 14 November 2017

Revised Date: 30 January 2018
Accepted Date: 12 February 2018

Please cite this article as: Zaki MN, Wing DA, McNulty JA, Comparison of Staples Versus Subcuticular
Suture in Class III Obese Women Undergoing Cesarean: A Randomized Controlled Trial, American
Journal of Obstetrics and Gynecology (2018), doi: 10.1016/j.ajog.2018.02.011.

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Zaki et al.

COMPARISON OF STAPLES VERSUS SUBCUTICULAR SUTURE IN CLASS III

OBESE WOMEN UNDERGOING CESAREAN: A RANDOMIZED CONTROLLED
TRIAL

Mary N. Zaki, MD1, Deborah A. Wing, MD, MBA1, Jennifer A. McNulty, MD2
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University of California, Irvine, Orange, CA, 2Miller Children and Women’s Hospital, Long

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Beach, CA.

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This is an “SMFM Fast-Track” Paper

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Trial was registered on ClinicalTrials.gov (Trial Registration number: NCT02466776).

Disclosure: The authors report no conflicts of interest.

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Funding Source: This study was funded by a grant from the MemorialCare Medical Center
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Foundation.

IRB#: 459-14, Approved on February 3, 2015.

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To be presented in oral presentation format on February 1, 2018 at the 37th Annual Meeting of
the Society of Maternal Fetal Medicine; Dallas, Texas held January 29-February 3, 2018. Control
ID #669, Program ID #037.
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Word Counts:
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Abstract: 354 words

Main text: 3000 words
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Corresponding Author:
Mary N. Zaki, MD
c/o Department of Ob-Gyn
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University of California, Irvine

333 City Tower East, Suite 1400
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Orange, California 92868

Email: mary.nasry@gmail.com

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Condensation: In Class III obese women undergoing cesarean delivery, no difference was

found in composite wound outcomes between staples and subcuticular suture skin closure.

Short Title: Skin closure in Class III obese women undergoing cesarean delivery

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Implications and Contributions:

A. To assess the rate of wound complications with staples versus subcuticular suture closure in

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women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery.

B. No difference was observed in wound complication rates between staples and subcuticular

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suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery.
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C. At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing

cesarean delivery remains unknown. More work is needed in this area to help reduce the
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complication rate in this very high-risk population.

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Abstract

Background: Obesity is a risk factor for infectious morbidity and wound complications after

cesarean delivery. There are currently insufficient data to determine optimal skin closure

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technique for cesarean delivery, specifically for those women with Class III obesity, defined as a

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body mass index (BMI) greater than or equal to 40 kg/m2.

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Objective: To compare stainless steel staples versus subcuticular suture for skin closure for

cesarean delivery in Class III obese women with body mass index of ≥ 40 kg/m2.

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Study Design: We conducted a randomized controlled trial at two teaching hospitals between

2015 and 2016 in which women with body mass index ≥ 40 kg/m2 undergoing cesarean delivery
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were randomly assigned to stainless steel staples or subcuticular suture skin closure. The primary
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outcome was composite wound complication defined as superficial or deep separation and
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infection occurring up to 6 weeks following delivery. Secondary outcomes included operative

time, and patient pain and satisfaction scores.

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Results: A total of 242 women were enrolled. One hundred and nineteen in the staples group and
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119 in the subcuticular suture group were analyzed. Maternal demographics and characteristics
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were similar in both groups. The composite wound complication frequency was 19.3% in the

staples group and 17.6% in the subcuticular suture group (p=0.74) with an overall wound

complication incidence of 18.5% in the entire study cohort. There were also no differences in the

frequencies of infection, superficial or deep wound separation among the two study groups. In a

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univariate analysis of predictors of wound complications, only current tobacco use was a

significant predictor of wound complications (RR 4.97 [95% CI 1.37-18.03], p=0.02). Fewer

women with staple closure would choose the same method with a future delivery (p=0.01),

however self-reported pain and concern about wound healing were equal among the two groups.

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Conclusion: In Class III obese women undergoing cesarean delivery, there was no difference in

composite wound outcome up to 6 weeks postpartum between those who had staples and those

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who had subcuticular suture skin closure.

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Keywords: cesarean delivery, Class III obesity, severely obese, skin closure, smoking, staples,
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surgical site infections, sutures, tobacco, wound infection, wound separation
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Trial Registration: NCT02466776

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Introduction

Obesity in the American population continues to increase as it has for more than four

decades. In 2014, according to the United States National Center for Health Statistics, 34.4

percent of women aged 20 to 39 years were obese with a body mass index (BMI) of 30 kg/m2 or

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greater.1 Approximately 10% are extremely obese with a BMI exceeding 40 kg/m2.2,3 Given

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current rates of cesarean delivery in the United States, more evidence is needed regarding

optimal peri-operative management of this high-risk population.4

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Obesity is a risk factor for many obstetrical complications, including failed induction,

cesarean delivery and post-operative wound complications.5,6 Multiple studies have

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demonstrated an increased risk of infectious morbidity and wound complications after cesarean
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delivery in obese compared to non-obese women, with a trend towards higher rates of

complications with increasing degrees of obesity.7-11 While the literature is replete with reports
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of evidence-based cesarean delivery technique for the general non-obese obstetrical population,
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the literature is sparse in terms of the optimal intraoperative and post-operative management of
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severely obese woman, specifically those with a BMI 40 kg/m2 or higher, undergoing.12

Moreover, there are insufficient data to determine optimal skin closure technique at time of
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cesarean delivery in obese patients, especially those women with Class III obesity, which is

defined as a body mass index (BMI) greater than or equal to 40 kg/m2.

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Recently, the use of subcuticular suture has been shown to result in improved wound
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outcomes compared to staples.13-15 A meta-analysis by Mackeen et al. which included studies

performed from 1997 to 2014 showed that subcuticular suture resulted in a 49% reduction in

wound complications without significant differences in pain, patient satisfaction, or cosmesis,

and increased operative time by only seven minutes.16 Two studies from this meta-analysis by

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Mackeen et al15 and Figueroa et al17 included cohorts of obese women. Mackeen et al included

235 obese women in the suture arm and 238 in the staples arm and demonstrated a 50%

reduction in wound complications with suture closure compared to staples, however, this study

did not include any women with a BMI 40 kg/m2 or higher.17 Figueroa et al similarly enrolled

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124 and 141 obese gravida in the suture and staples arm with a mean BMI of 36.8±8.1 and

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35.9±8.5 kg/m2, respectively, but it is unclear what percentage of their study cohort had a BMI

40 kg/m2 or higher, and whether increasing degrees of obesity had an effect on the rate of wound

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complications.15 Therefore, our study aims to determine the optimal skin closure technique at

time of cesarean delivery specifically in Class III obese women (BMI ≥ 40 kg/m2).

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Materials and Methods

We performed a randomized trial at two sites: The University of California, Irvine (UCI)
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Medical Center in Orange, California and Miller Children’s and Women’s Hospital in Long
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Beach, California. The study protocol was IRB approved for enrollment at both sites and was
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registered on ClinicalTrials.gov (Identifier: NCT02466776). All study participants provided

written informed consent prior to study enrollment. Subjects were recruited from April 2015 to
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November 2016.

Women undergoing planned cesarean delivery who were at least 23 weeks gestational
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age and with a BMI ≥ 40 kg/m2 were approached for study participation. Women admitted for
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induction of labor or in spontaneous labor who met the BMI criteria and had adequate pain

control (pain scale 3 or less on a 1-10 pain scale) were also approached for study participation, in

the event cesarean delivery subsequently occurred. Women with reported hypersensitivity to

staples or potential immune suppression including infection with human immunodeficiency

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virus, chronic steroid use or active lupus were excluded. Maternal height and weight at time of

hospital admission was used to calculate BMI with the following formula: weight (kg)/height

(m)2.3

Randomization, using predetermined computer-generated blocks of 20, was achieved

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using sequentially numbered, sealed opaque envelopes, which were opened by the obstetrician at

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the time of surgery prior to skin preparation. Once randomized, study group allocation was not

blinded. All patients underwent a subcutaneous closure based on previously published literature

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showing an advantage of closure with a subcutaneous thickness of 2 centimeters or greater.18 The

type of subcutaneous suture was at the surgeon’s discretion. Either 4-0 vicryl (polyglactin) or 3-

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0 monocryl (poliglecaprone) were used for skin closure in patients allocated to the subcuticular
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suture group. All patients received a single dose of antibiotic prophylaxis with cefazolin 3 grams

IV prior to skin incision and routine skin preparation with chlorhexidine solution.19 Those with a
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severe penicillin allergy received standard dose gentamicin and clindamycin also prior to skin
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incision. The remainder of the surgical technique and postoperative care was at the discretion of
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the surgeon. Steri-strips were placed at time of skin closure in the suture group and at time of

staple removal in the staples group.

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Intrapartum and surgical outcomes were collected by the circulating nurse at the time of

surgery using a standardized data collection form. Prior to discharge on post-operative day 3 or
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4, the wound was evaluated by the study team using an objective wound assessment form which
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included erythema, (ranked none, suspect cellulitis, definite cellulitis), drainage (ranked none,

small, moderate or large), induration (ranked none, <2 cm, 2-4 cm, >4 cm), separation,

hematoma, seroma and presence of necrotic tissue. Overall impression was also recorded (no

concerns, infection or separation). For those women randomized to staples closure, time of staple

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removal was left at the discretion of their physician.

Subjects were seen by the study team 7 to 14 days after hospital discharge for wound

assessment and administration of a satisfaction survey in which women were asked to report

their observations of the wound, overall pain score and satisfaction with wound healing. The

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study team was not blinded to group allocation. If a woman missed her follow-up appointment,

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the wound assessment and patient survey were completed over the phone and included their

observation of discharge, separation and erythema, if present. Additionally, women were

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contacted by telephone between 6 to 8 weeks postoperatively and evaluated with a standardized

questionnaire to determine if they had required additional care for wound complications. Lastly,

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records from the two delivery hospitals were reviewed to identify any hospital admissions or
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emergency department visits for wound complications. Women were considered lost to follow-

up if no follow-up could be obtained at 7 to 14 days and 6 to 8 weeks postpartum.

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Wound separations were identified as either superficial (less than 0.5 cm deep and only
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involving the dermis layer) or deep (greater than 0.5 cm in depth and requiring packing or re-
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closure) resulting from hematoma or seroma. Wound infections were those meeting the CDC

definition of surgical site infections and requiring antibiotic therapy.21 The wound complication
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composite included infection and any wound separation. The primary outcome of our study was

the composite wound complication rate up to 6 weeks postpartum among Class III obese women
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receiving staples or subcuticular suture skin closure. The incidence of wound complications in
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Class III obese women has been reported to be as high as 30% in those with a BMI of 50 kg/m2.5

Therefore, we assumed a wound complication rate of 25% in the Class III obese women who

receive staple closure. We aimed to reduce this by 60% to a rate of 10% in the suture closure

group, applied a beta-error of 0.20, and therefore needed 110 in each group for a total of 220

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women. To account for a 10% lost to follow-up rate, we enrolled an additional 22 women, for a

total of 242 women.

Distribution of demographic characteristics, delivery outcomes, and average satisfaction

with procedure were compared between the two study groups using Chi-square or Fisher’s exact

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test for categorical variables and independent t-test for continuous variables. Relative risk with

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95% confidence intervals for wound complication was determined using generalized linear

model (GLM) procedure with binomial logistic regression specified and robust covariance

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estimator. All tests were considered significant at the .05 level. Analyses were performed using

SPSS version 18.0.

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Results

A total of 594 women were approached and screened for study participation between
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April 2015 and November 2016. One-hundred, seventy-four declined to participate, 66 delivered
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vaginally prior to consenting and 21 did not qualify. There were 333 women who agreed to
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participate and were consented, of whom 91 ultimately delivered vaginally. A total of 242

women were randomized to staples (n=121) or suture (n=121) skin closure. In the suture group,
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two patients were lost to follow-up, while in the staples group one patient was lost to follow-up

and one was withdrawn due to failure to follow study protocol. This resulted in a final cohort of
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238 with 119 in each group for analysis (Figure 1).

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The baseline characteristics were similar among the two groups (Table 1). The mean BMI

was 45.1 ± 4.4 kg/m2 in the staples group and 46.2 ± 5.5 in the suture group. More than half of

the women in each group self-identified as Hispanic and greater than 50 percent in each group

underwent a pre-labor, repeat cesarean delivery. The incidence of gestational and pre-gestational

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diabetes was similar in each group and the occurrence of chorioamnionitis was also not different

between the two groups. The mean operative time was 12 minutes longer in the suture group

(55.8 ± 26.0 vs. 43.4 ± 21.9 minutes, p<0.001). There were no other differences in surgical or

delivery outcomes (Table 2). Among the 119 patients who had staple skin closure, staple removal

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occurred on the day of hospital discharge (post-operative day 3 or 4) in 73.7%. Of the 26.3% of

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women who had staple removal after discharge, the median post-operative day of staple removal

was six.

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There were no significant differences in early wound complications between the two

groups at time of hospital discharge (Table 3). There were seven superficial wound separations in

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the staples group and three in the suture group (p=0.19). A deep separation occurred in one
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patient in the staples group and two patients in the suture group (p=0.50). There was no
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difference in wound complications based on time of staple removal with wound complications

rates of 17.2% in those who had their staples removed at time of discharge and 25.8% in those
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women who had their staples removed after discharge, p=0.30.

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At the post-operative wound inspection 7 to 14 days after hospital discharge, the

composite wound complication rate was 12.6% (15/119) in the staple group and 13.4% (16/119)
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in the suture group, p=0.85 (Table 3). There were no additional wound complications occurring

after the 7 to 14-day wound inspection visit. Therefore, the total composite wound complication
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frequency was 19.3% in the staple group and 17.6% in the suture group (p=0.74) yielding an
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overall wound complication rate of 18.5% in the entire study cohort. Of those who had a wound

complication diagnosed at the 2-week wound check visit and who had 6-week follow-up

outcomes available, 12 out of 15 patients in the staples group had achieved complete healing,

while 11 out of 12 patients in the suture group had achieved complete healing.

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Using a standardized patient satisfaction survey at the 7 to 14 day wound check visit, we

found no significant difference in pain score between the two groups, p=0.71 (Table 4). There

was also no difference in women’s satisfaction with the appearance of their wound as well as

their concern about wound healing, p=0.99 and 0.22, respectively. However, when women were

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asked if they would choose the same closure again, those women who had staple closure were

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significantly less likely to desire the same closure method in future deliveries, p=0.01. The

presence of any wound complication influenced overall satisfaction; women with no wound

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complication (N=187) had a median satisfaction score of 10 [IQR 9.0-10.0], on a 10-point scale,

and those with a wound complication had a median satisfaction score of 9.0 [IQR 7.5-10.0],

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p<0.001. Satisfaction also differed if women had a superficial wound separation (N=23, median
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satisfaction score 10.0 [IQR 9.0-10.0]) compared to those who experienced a deep wound

separation (N=3, median satisfaction score 1.0 [IQR 1.0-6.0]), p<0.001.

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In the univariate, unadjusted analysis of predictors of wound complications, only current

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tobacco use was found to be a significant predictor of wound complications in this severely
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obese patient population (RR 4.97 [95% CI 1.37-18.03], p=0.02) (Table 5).
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Comment

Improvement in surgical techniques for cesarean delivery given its prevalence in the
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United States and globally is imperative.12 Additionally, with the rising rates of obesity,
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evaluation of optimal skin closure technique at time of cesarean delivery is warranted. The

primary outcome of this study was composite wound complication in Class III obese women

undergoing cesarean delivery. We did not find a difference between staples and suture skin

closure, presumably due to an overall lower wound complication rate than originally anticipated

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at the time of study development. Secondary outcomes were significant for a preference for

suture closure in future pregnancies in women who received sutures in the current pregnancy,

and an increase in total operative time by 12 minutes in those receiving sutures. While small, this

increase in operative time nevertheless represented a 27% increase in patients undergoing suture

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skin closure which is similar to previously published studies, and is of importance as we look

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toward standardized and value-based medicine.13,14,16,20,21,24,25

Several recent trials and subsequent meta-analyses comparing wound outcomes with

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staple versus subcuticular sutures demonstrate a reduction in wound complications with

subcuticular suture skin closure.14-18 One of our authors previously reported on 1147 obese

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women with BMI of 30 kg/m2 or greater undergoing cesarean delivery with staples or
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subcuticular suture for wound closure.22 The mean BMI in the staples group was 40.6 kg/m2 and

36.1 kg/m2 in the suture group. They found an overall wound complication rate of 15.5% with a
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22% wound complication rate in the staples group and 9.7% in the suture group. Our overall
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wound complication rate was similar at 18.5% despite the fact that enrollment in the current
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study was limited only to women with class III obesity. We anticipated finding superiority with

suture closure, however, due to a low frequency of wound complications, this was not seen.
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More women expressed a preference for suture closure in future pregnancies if they were

assigned to sutures during the current pregnancy, a finding that is interesting in assessing overall
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patient cesarean experience and satisfaction with their care. These findings are in agreement with
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previously published studies, including one by Basha et al. who found lower satisfaction in

women with wound complications but no difference in satisfaction scores between the staple and

suture groups once they controlled for wound separation.25-28 Figueroa et al. also found no

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difference in pain scores, cosmetic outcome as defined by the Stony Brook Scar Evaluation

Scale, or scar satisfaction among staples versus subcuticular suture.15

The strengths of our study include its prospective approach and a very high follow-up

rate. We chose to randomize patients with broad inclusion criteria at two centers with different

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patient and provider characteristics. One is a community based, academic affiliated hospital with

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a diverse group of private physicians while the other is a university hospital where all patients are

cared for directly by resident physicians. Additionally, we designed this study so that each

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woman enrolled would have two visual wound inspections by trained research personnel. Only

three women (1.2%) in our investigation were lost to follow-up. We ensured that no wound

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complications were missed by placing an additional telephone call and conducting a chart review
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at 6 to 8 weeks postpartum.

A potential limitation is the timing of staple removal was not standardized. Indication for
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delayed staple removal was also a measure that was not collected. This could have created bias
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and affected our results if staples were left in place longer for those wounds which appeared
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concerning at time of discharge. Additionally, physicians were allowed to use either of the suture

types already in widespread use at the two hospitals for skin closure (4-0 vicryl and 3-0
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monocryl). While a recent study by Tuuli et al did not demonstrate a difference in wound

outcomes between vicryl and monocryl suture closure in the general non-obese population, there
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is a potential that the variation of suture type could have confounded our results.29 Although the
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study team was not blinded to closure method at the time of wound assessment, a detailed,

standardized wound assessment tool was utilized to allow for an objective assessment of each

wound. Nevertheless, there remains the potential for bias in wound assessment. Because our

anticipated wound complication rate was lower than planned, our study was under-powered to

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detect differences in wound complication frequencies between patients with staples compared to

suture skin closure. The wound complication rate and effect size was computed based on

previously mentioned studies by Alanis et al. and Zaki et al.5,22 However, this may have been an

over-estimation because as this study was nearing completion, a study by Smid et al. was

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published using the Maternal-Fetal Medicine Unit Cesarean Registry and found a lower wound

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complication rate in the extremely obese (14%), likely reflective of improved standardization of

peri-operative management of this high-risk population. 5,11,22 Another explanation could also be

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the Hawthorne effect where both patients and providers may have been more vigilant with the

wound closure and post-operative wound care, respectively, resulting in a decrease in

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complications overall.23 A post-hoc sample size calculation demonstrated that to detect a
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significant difference with a wound complication rate of 18.5%, we would have needed to enroll

a total of 436 women to demonstrate a 50% reduction or 284 women to detect a 60% reduction in
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wound complications (alpha = 0.05, beta = 0.20).

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In summary, we aimed to assess wound complication rates with staples versus

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subcuticular suture in obese women with a body mass index of 40 kg/m2 or higher undergoing

cesarean delivery. No difference in composite wound complication was detected between women
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undergoing staples compared to subcuticular suture skin closure. At this time, a definite

conclusion cannot be drawn regarding superiority of one method of skin closure over the other in
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the severely obese population. Future directions include larger trials that are more generalizable
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and more geographically distributed.

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Acknowledgements: We are grateful for the support of the Long Beach MemorialCare Fund for

their financial support of this study.

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Perinatol. 2016 Oct;36(10):819-22.

23. McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect:

New concepts are needed to study research participation effects. Journal of Clinical

Epidemiology. 2014;67(3):267-277.

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24. Rousseau JA, Girard K, Turcot-Lemay, et al. A randomized study comparing skin closure

in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol 2009;200:265.

25. Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized

controlled trial of wound complication rates of subcuticular suture vs staples for skin

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closure at cesarean delivery. Am J Obstet Gynecol 2010; 203(285): e1–e8.

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26. Mackeen AD, Khalifeh A, Fleisher J, Han C, Leiby B, Bergella V. Pain associated with

cesarean delivery skin closure: a randomized controlled trial. Obstet Gynecol. 2015

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Oct;126(4):702-7.

27. Aabakke AJM, Krebs L, Pipper CB, Secher NJ. Subcuticular suture compared with

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staples for skin closure after cesarean delivery: a randomized controlled trial. Obstet
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Gynecol 2013;122:878-84.

28. Huppelschoten AG, van Ginderen JC, van den Broek KC, Bouwma AE, Oosterbaan HP.
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Different ways of subcutaneous tissue and skin closure at cesarean section: a randomized
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clinical trial on the long-term cosmetic outcome. Acta Obstet Gynecol Scand
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2013;92:916-24.

29. Tuuli MG, Stout MJ, Martin S, Rampersad RM, Cahill AG, Macones GA. Comparison of
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suture materials for subcuticular skin closure at cesarean delivery. Am J Obstet Gynecol.

2016 Oct;215(4):490.e1-5.
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Tables

Table 1. Baseline Characteristics

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Characteristics Staples Sutures
(N=119) (N=119)

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Maternal age (years) 31.1 ± 5.6 31.4 ± 5.3
Nulliparous 30 (25.2) 31 (26.1)
BMI (kg/m2) 45.1 ± 4.4 46.2 ± 5.5

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Race
African American 22 (18.5) 19 (16.0)
Asian 5 (4.2) 10 (8.4)
Caucasian 22 (18.5) 24 (20.2)

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Hispanic 68 (57.1) 59 (49.6)
Other 2 (1.7) 7 (5.9)
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Married/partner 66 (55.9) 69 (59.0)
College graduate 21 (19.4) 23 (20.5)
Private insurance 31 (26.3) 28 (23.7)
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Singleton gestation 114 (95.8) 111 (93.3)

Gestational age at delivery (weeks) 38.2 ± 2.5 38.8 ± 1.9
CD Indication
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Primary pre-labor 15 (12.6) 12 (10.1)

Primary in labor 27 (22.7) 30 (25.2)
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Repeat pre-labor 61 (51.3) 63 (52.9)

Repeat in labor 16 (13.4) 14 (11.8)
Number of previous CD
One 42 (35.3) 36 (30.3)
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Two or more 35 (29.4) 38 (31.9)

Time since last CD (years)
(n=77) (n=74)
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Within past five years 44 (57.1) 41 (55.4)

More than five years ago 33 (42.9) 33 (44.6)
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Diabetes
Pre-gestational 19 (16.0) 19 (16.0)
Gestational 23 (19.3) 18 (15.1)
Hypertension
Pre-gestational 16 (13.4) 9 (7.6)
Gestational 10 (8.4) 12 (10.2)
Preeclampsia 20 (16.8) 13 (11.0)
Other medical comorbidities* 17 (14.3) 20 (16.8)
Tobacco use
Current 3 (2.5) 7 (5.9)

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Past 26 (21.8) 16 (13.6)

Chorioamnionitis 3 (2.5) 4 (3.4)
BMI: body mass index; CD: cesarean delivery
* Includes asthma, congenital bleeding disorder, coagulopathy, chronic kidney disease
Data were analyzed with independent t, X2, and Fisher’s exact tests, where applicable
Data are presented as mean ± SD or n (%)
P-value <.05 indicates significance; all characteristics non-significant

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Table 2. Surgical, Delivery and Neonatal Outcomes

Delivery Outcomes Staples Sutures P value

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(N=119) (N=119)
Skin incision
Pfannenstiel 118 (99.2) 114 (95.8) .11
Midline vertical 1 (0.8) 5 (4.2)

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Surgeon level
Attending/Fellow 67 (56.3) 66 (55.5) .90
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Resident 52 (43.7) 53 (44.5)
Assistant level
Attending/Fellow 101 (84.9) 97 (81.5) .49
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Resident 18 (15.1) 22 (18.5)

Total operative time (min) 43.4 ± 21.9 55.8 ± 26.0 <.001
Blood loss (mL) 773 ± 432 837 ± 447 .26
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Blood transfusion 4 (3.4) 8 (6.7) .24

Decline in Hgb (pre- to post- delivery) (grams) 1.68 ± 1.5 1.93 ± 1.4 .25
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Birthweight (grams) 3406 ± 878 3426 ± 711 .85

5 minute Apgar Score <7 2 (1.7) 1 (0.8) .55
Postpartum prophylactic anticoagulation 66 (55.5) 74 (62.2) .29
4.9 ± 0.9 4.9 ± 2.1
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Length of hospital stay (days) 1.00

2
Data were analyzed with independent t, X , and Fisher’s exact tests, where applicable
Data are presented as mean ± SD or n (%)
P-value <.05 indicates significance
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1 Table 3. Cesarean Wound Outcomes

2
At Hospital Discharge At 2 Weeks Postpartum TOTAL

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Staples Sutures P Staples Sutures P Staples Sutures P
(N=118 (N=119) value (N=119) (N=119) value (N=119) (N=119) value
a
)

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Composite wound complication 8 (6.7) 5 (4.2) .38 15 (12.6) 16 (13.4) .85 23 (19.3) 21 (17.6) .74

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Infection 0 (0.0) 0 (0.0) -- 3 (2.5) 2 (1.7) .65 3 (2.5) 2 (1.7) 65
Superficial separation 7 (5.9) 3 (2.5) .19 11 (9.2) 11 (9.2) .47 15 (12.6) 14 (11.8) .84
Deep separation 1 (0.8) 2 (1.7) .50 3 (2.5) 0 (0) .12 4 (3.4) 2 (1.7) .41

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Infection + separation 0 (0.0) 0 (0.0) -- 1 (0.8) 3 (2.5) .31 1 (0.8) 3 (2.5) .31

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6-week outcome of wound N=8 N=5 N=15 N=12
complications
Healed 6 (75.0) 4 (80.0) 1.00 € 12 (80.0) 11 (91.7) .61 € -- -- --

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Not healed 2 (25.0) 1 (20.0) 3 (20.0) 1 (8.3)
a
3 Outcome recorded in 118 of 119 patients who had staple closure
Data were analyzed with independent t, X2, and € Fisher’s exact tests, where applicable

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4
5 Data are presented as n (%)

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6 P-value <.05 indicates significance
7
8
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9
10
11
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14 Table 4. Patient Satisfaction and Pain Assessment

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Staples Sutures P value
(N=114) (N=113)
Pain level (1=least, 10=most) 2 [1-3] 2 [1-3] .71
Wound appearance satisfaction (1=least, 10=most) 10 [9-10] 10 [9-10] .99
Concern about wound healing (1=least, 10=most) 1 [1-2] 1 [1-2] .22

PT
Would you have same closure again?
Yes 98 (83.1) 108 (93.9) .01
No 20 (16.9) 7 (6.1)

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2
16 Data were analyzed with Mann-Whitney U and X tests, where applicable
17 Data are presented as median [interquartile range] or n (%)
18 P-value <.05 indicates significance

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20
21
22

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23 Table 5. Predictors of Wound Complications a
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Relative Risk (95% CI) P value
BMI (>50 vs. <50) 1.66 (0.72-3.85) .24
Any diabetes (any vs. none) 1.70 (0.87-3.32) .12
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Any hypertension 0.90 (0.45-1.81) .76

Current tobacco use (current or prior) 4.97 (1.37-18.03) .02
Insurance (private vs. public) 0.89 (0.41-1.94) .77
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Parity (nulliparous vs. multiparous) 0.70 (0.32-1.56) .39

Time since last CD (<5 years vs. >5 years ago) 0.80 (0.35-1.85) .61
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Cesarean delivery .64

Primary pre-labor Reference --
Primary in labor 2.13 (0.55-8.30) .27
Repeat pre-labor 1.73 (0.48-6.24) .41
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Repeat in labor 2.44 (0.56-10.57) .24

Surgeon (Attending vs. Resident) 0.75 (0.39-1.44) .39
Assistant (Attending vs. Resident) 0.74 (0.32-1.69) .48
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Skin incision (Pfannenstiel vs. midline vertical) 4.67 (0.91-23.91) .07

Closure method (Staple vs. Suture) 1.12 (0.58-2.15) .74
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Operative time (>60 vs. ≤60 min) 1.59 (0.78-3.26) .21

Chorioamnionitis 0.73 (0.09-6.21) .77
Use of anticoagulation 1.45 (0.73-2.87) .29
a
25 Unadjusted analysis; data were analyzed with generalized linear model (GLM) with binomial
26 logistic regression
27 CI, confidence interval
28 P-value <.05 indicates significance
29
30

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Figures

Figure 1. Flow Diagram of Study Enrollment

594 screened

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174 (29%) declined to participate
66 NSVDs prior to consent
21 did not qualify for other

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reasons
333 consented

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91 delivered vaginally

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242 randomized
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M

Sutures (N=121) Staples (N=121)

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2 lost to follow-up 1 withdrawn

1 lost to follow-up
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EP

Analyzed for wound Analyzed for wound

complication (N=119) complication (N=119)
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