JBUR-4555; No.

of Pages 11

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A prospective clinical trial comparing BiobraneW

DressilkW and PolyMemW dressings on
partial-thickness skin graft donor sites

Alexandra Schulz a,1,*, Christian Depner b,1, Rolf Lefering c,

Julian Kricheldorff a, Sonja Kästner a, Paul Christian Fuchs a, Erhan Demir a
a
Department of Plastic Surgery, Hand Surgery, Burn Center, University of Witten/Herdecke, Cologne-Merheim Medical
Center (CMMC), Cologne, Germany
b
Artemedic AG, Clinic for Plastic Surgery, Zurich, Switzerland
c
IFOM, University of Witten/Herdecke, Cologne-Merheim Medical Center (CMMC), Cologne, Germany

article info abstract

Article history: Introduction: In a single-center, prospective, randomized clinical trial three different config-
Accepted 25 December 2014 ured wound dressings Biobrane1, Dressilk1 and PolyMem1 were compared with each other
regarding objective and subjective healing parameters and cost efficiency.
Keywords: Methods: 28 burn patients received surgical treatment with split-thickness skin grafting,
Wound dressing while utilizing Biobrane1, Dressilk1 and PolyMem1 as a single bound donor site wound
Partial thickness burn dressing in all patients. Following a standardized case report form, we monitored several
Reliable wound evaluation parameters such as pain, transparency of the dressing, active bleeding, exudation and
Cost effective wound care inflammation by using the Verbal Rating Scale 1–10 through out.
Reducing complication rates Results: With regard to re-epithelialization, pain and acute bleeding all three dressings were
equivalent. Dressilk1 and Biobrane1 presented clearly superior to PolyMem1 in both wound
assessment and in the reduction of mild inflammation and exudation. High subjective
satisfaction rates were reported with Dressilk1 and Biobrane1 dressings in regard to
comfort and mobility. During the continuous monitoring period Biobrane1 outperformed
Dressilk1 by providing higher wound transparency rates and offering a better level of
wound control during the entire study period. Regarding their cost efficiency, PolyMem1
and Dressilk1 are clearly superior to Biobrane1.
Conclusion: The ‘‘ideal’’ wound dressing maximizes patients’ comfort while reducing pain
and the risk of pulling off migrating epidermal cells from the wound surface. In addition
reliable wound status evaluation (minimizing complications), an increase of treatment cost
value efficacy, and reduced hospitalization rates should be provided. Dressilk1 and Bio-
brane1 were favored by patients and surgeons for providing an effective and safe healing
environment, with overall low complication rates with respect to infection and exudation.
Regarding cost-effectiveness PolyMem1 and Dressilk1 presented superior to Biobrane1.
# 2015 Elsevier Ltd and ISBI. All rights reserved.

* Corresponding author at: Department of Plastic Surgery, Hand Surgery, Burn Center, University of Witten/Herdecke, Cologne-Merheim
Medical Center (CMMC), Ostmerheimer Strasse 200, 51109 NRW, Cologne, Germany. Tel.: +49 0221 8907 0; fax: +49 0221 8907 3878.
E-mail address: schulza@kliniken-koeln.de (A. Schulz).
1
These authors contributed equally to this work.
http://dx.doi.org/10.1016/j.burns.2014.12.016
0305-4179/# 2015 Elsevier Ltd and ISBI. All rights reserved.

Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
JBUR-4555; No. of Pages 11
2 burns xxx (2015) xxx–xxx
1. Introduction
Skin graft donor regions or partial thickness burns usually
receive wound dressings to address three principal functions
such as comfort, metabolic and protective aspects [1].
Firstly, superficial burns are initially extraordinarily sensi-
tive to air currents and open wounds produce a substantial
amount of drainage. The dressing shields the wound surface
against air currents in the environment, absorbs and contains
wound secretion. In addition if properly designed, it may also
provide splinting functions to maintain the desired position of
function, while limiting movement.
Secondly, any occlusive dressing will reduce evaporative
heat loss minimizing cold stress with associated symptoms
such as shivering. Even superficial burns and skin donor
regions demonstrate substantial water vapor loss due to the
fact that the principal cutaneous water vapor barrier resides in
the epidermis.
Thirdly, if loss of the epidermal physical barrier function
against microorganisms occurs, an addition of a mild
antiseptic property will ease environmental flora proliferation
on the wound surface.
In summary, the ideal wound dressing should have the
following properties (a) consisting of biocompatible and
cytocompatible natural or artificial materials; (b) reducing
inflammatory possibility, disease transmission and host
immune response; (c) supporting cell migration and attach-
ment due to its optimized architecture; (d) retaining hydration
of the wound; (e) stabilizing the wound bed; (f) supporting
rapid healing of the wound with good cosmetic results [2–4].
Furthermore, the dressing itself should be priced fairly,
which will lead to cost-effectiveness by limiting the duration
of hospital stay and preventing complications by providing
optimal treatment and maximizing patients’ comfort.
An ever-increasing number of commercially available
synthetic dressings and bioengineered products have been
applied to cover the donor site so far [5].
Wound dressings currently are no longer simple covers, but
are expected to be a sufficient wound treatment option by
themselves [6–8].
They are mainly categorized in moist (e.g. Tegaderm1
(3M, Germany), Aquacel Ag 1 (ConvaTec, Germany), Kaltos-
tat 1 (CanvaTec, Germany)) and dry dressings (e.g. Scarlet
Red1 (Covidien, Ireland), Xeroform 1 (Covidien, Ireland),
Jelonet 1 (Smith & Nephew, United Kingdom ), PolyMem1
(Ferris Mfg. Corp., U.S.A.), Biobrane 1 (Smith & Nephew,
United Kingdom ), Dressilk1 (PREVOR, France)) [5]. In our
department partial-thickness skin graft donor sites were
covered with PolyMem 1 due to low treatment costs and
simple handling. Considering the high degree of comfort but
limited by the price we would rather prefer to cover the donor
sites with Biobrane 1. Dressilk1 and Biobrane1 share similar
product features regarding patients comfort, transparency
and adherence. Therefore the clinical study layout compared
Dressilk 1 with these two dressings in the present prospective
study.
PolyMem1 (Ferris Mfg. Corp., U.S.A.) is a synthetic dressing
material mainly applied to temporarily cover cutaneous skin
defect wounds prior to definitive closure, partial thickness
Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
burns or split thickness skin graft donor sites. It consists
of a hydrophilic polyurethane membrane matrix with a
semi-permeable polyurethane continuous thin film backing
(consisting of a mild cleanser, glycine and a super absorbing
Polymer). The dressing purpose is to cleanse, to fill, to absorb
and to moisten wounds throughout the healing continuum [9].
This way it promotes concentration of the body’s naturally
producing growth factors, nutrients and regenerating cells
in the wound bed, while reducing the number of dressing
changes by absorbing and therefore minimizing the need
for manual wound bed cleansing procedures. Being a non-
adherent material, dressing changes are reported to cause
little pain with overall reduction in wound pain and
enhancement of patients comfort [10–14]. Additional compar-
ison studies observed that wounds covered with PolyMem1
showed pain reduction because the dressing changes were
fast and rare and the dressing did not adhere to the wound
in comparison to conventional dressing materials [15]. Pain
medication and healing time could be decreased and patients’
mobility improved. Furthermore, decreased infection rates
were found. Some authors therefore refer that PolyMem1 is
one of the ideal dressing materials for these kinds of wounds
[9,14,16,17].
Biobrane1 (Smith & Nephew, United Kingdom) was the first
skin substitute used to promote epithelialization on partial-
thickness burns and donor harvest sites. It is a transparent,
temporary biosynthetic adherent wound covering [18]. Bio-
brane1 is constructed of a nylon mesh, which is covered by
porcine type one collagen. With this structure it facilitates the
ingrowth of fibrin, creates new tissue matrix and adheres
temporary on the wound [19–21]. Handling of Biobrane1 is
uncomplicated and can easily be taught to residents and
nurses [20]. After cleansing the wound it is applied once and
does not undergo additional handling as the wound stays
clean. The dressing spontaneously detaches by re-epitheliali-
zation [21]. Reaction to the skin like dermatitis or scarring is
rarely reported in literature [22]. Biobrane1 is highly priced
compared to other dressing materials for cutaneous wounds
and is a very popular choice for the treatment of cutaneous
wounds in the current reports [20,23–27]. Therefore, many
authors suggest Biobrane1 as the ideal dressing material
for cutaneous wounds like partial-thickness burns and donor
harvest sites, especially in the treatment of pediatric burns
[20,23,27–29].
Dressilk1 (PREVOR, France) consists of silkworm silk
from which the protein Fibroin remains. Spider silk protein
as a natural biocompatible protein seems very promising in
the development of new biomaterial applications and in the
context of tissue engineering such as artificial tendons, joints,
ligaments and many more products [30]. It is a very robust
material, demonstrating in many different studies a positive
effect on wound healing and prevention of inflammation [31].
Safety studies on rat skin confirmed that this material is safe
for acute dermal toxicity, irritation and skin sensitization
[32,33]. Different studies revealed high cell attachment rates
and spreading of keratinocytes and fibroblasts, promising
to be utilized as a wound dressing material [34,35]. It is
particularly interesting, because of its enlargement potential
in horizontal and vertical dimensions providing better comfort
to any applied cutaneous area. Dressilk1 adheres well to the
JBUR-4555; No. of Pages 11
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wound as it becomes dry and is transparent on wet wounds.
Once applied Dressilk1 like Biobrane1 does not have to be
removed or changed if the wound stays clean. It is temporary
adherent and peels off by itself when the re-epithelialization
of the wound is completed.
In the present study we tried to narrow the selection range
in the search for a suitable wound dressing by comparing
PolyMem1, Dressilk1 and Biobrane1 while utilizing a ran-
domized prospective within-subject design.
2. Methods
The following study was reviewed and approved by the Ethical
Review Committee of the University of Witten Herdecke,
Germany (votum nr. 103/2011). Complete informed consent
was obtained from all patients.
2.1. Materials
Three different dressings Biobrane1, Dressilk1 and Poly-
Mem1 were compared in the context of split-thickness
skin grafting donor site management of adult patients
with emphasis on five important characteristics of dressing
materials: intensity of pain, transparency, wound exuding,
rate of infection and active bleeding.
Biobrane1 and PolyMem1 were already routinely applied
to cover partial-thickness skin graft donor sites in our
institution, whereas Dressilk1 is a new biomaterial.
2.2. Patient selection
28 patients with burn wounds, scheduled for partial-thickness
skin grafting, were enrolled. Inclusion criteria were as
follows (a) participants must be at least 18 years old, in a
good physical condition, both genders, (b) harvesting of partial
thickness skin graft of at least 5 cm  15 cm is necessary,
(c) patients agree both to participate in the study and to take
part in the follow-up examinations following their hospital
discharge.
Exclusion criteria were listed as (a) lack of consent and
compliance to participate in the study and the required follow-
up examinations, (b) acute instability, (c) pregnancy or
nursing, (d) awareness of dressing allergy (those used in the
study), (e) skin injuries caused by a long term therapy with
cortisone, and (f) dysfunction of blood clotting.
Fig. 1 – Randomized treatment plan and application of the three wound dressings BiobraneW, DressilkW and PolyMemW on
partial-thickness skin graft donor sites.
Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
3
2.3. Randomization
The surgeon in charge randomized the order of the three
dressings by taking one of a few sealed envelopes, after receipt
of the patient informed consent.
2.4. Therapeutic regimen
The following study is designed as a single-center, prospective
and randomized controlled trial. Three wound dressings,
Biobrane1, Dressilk1 and PolyMem1, in the size of
5 cm  5 cm each, were applied on the donor sites following
routine 0.2 mm partial-thickness skin graft harvest.
Any adverse events were noted throughout the complete
study period.
2.4.1. Surgical procedures
All operations were performed under general anesthesia.
Patients were prepared and prepped for the operation in a
common fashion. Prior skin grafting burn wounds were either
debrided or eschar was excised. Harvesting of skin grafts was
performed in a standardized setting and procedure. Surgery
was conducted by the principal investigator or by the burn
surgeon’s staff. The lateral surface of the upper leg of either
side, which has previously not been used for harvesting skin
grafts, was planned as the donor site in all cases. In a first step
an area of 5 cm  15 cm was marked. An Aesculap1 derma-
tome (Aesculap AG, Germany) was utilized to harvest the
desired skin graft of 0.2 mm depth. While the harvested skin
graft was further processed as desired, the donor site wound
was covered in a randomized order as mentioned above with
Biobrane1, Dressilk1 and PolyMem1 patches in the size of
5 cm  5 cm (Fig. 1). All wound dressing materials were fixed in
the same procedure with skin staplers.
Two digital images of the wound were recorded prior and
after the dressing application. Finally the entire dressing
was covered with a layer of meshed gauze and a sterile
dressing pad.
After this step the surgery was continued individually.
2.4.2. Postoperative care
All study wounds were evaluated and documented at the time
points of day 2, 4, 6, 8, 10, 12, 14 and 16, 24, 48, 3 months and in
the final follow-up after 6 months after surgery. For docu-
mentation the mesh gauze was changed daily until the wound
and the covering dressings were dry. As soon as the dressings
JBUR-4555; No. of Pages 11
4 burns xxx (2015) xxx–xxx
were adherent to the wound we did not apply any kind of
additional external dressing materials. Staples were removed
two days after surgery to prevent unnecessary scars. The three
dressings were moistened with Prontosan1 disinfectant
solution (B. Braun, Germany) on a daily basis. In case of
any sign of inflammation, study dressings were completely
removed. The wound was cleaned with Prontosan1 solution
and conventionally treated with several layers of gauze
and pads on a daily basis. In this case documentation and
evaluation of the wound was continued as presented in Fig. 2.
In cases without infection dressings were left on the wound
until they peeled off spontaneously.
2.4.3. After discharge
After discharge all patients were instructed to return to the
hospital for donor site assessment, for the external dressing
change, and any further wound therapy if necessary. All
28 allocated patients showed compliance to the study and
took part in all follow up examinations. Therefore there
were no dropouts in the study.
2.5. Wound evaluation
The healing process was evaluated every second day for the
first 16 days. Afterwards follow – up periods were extended to
24 days, 48 days, 3 months and 6 months after surgery.
All covered wounds were evaluated by the principal
investigator and documented in a standardized case report
form in respect to (1) the intensity of pain as reported by the
patients, (2) interpretation capacity, (3) active bleeding, (4)
exuding of the wound and (5) inflammation. Results were
expressed using the Verbal Rating Scale 1–10 (1 = no event,
10 = maximum expression of event). All wounds were docu-
mented by standardized digital photography imaging.
Evaluation of active bleeding, exuding and inflammation of
the wound is done by wound inspection during the change of
external dressing every second day. In case of inflammation
the dressing itself is removed and a dressing of fatty gauze
applied. Wounds covered with PolyMem1 are evaluated by
inspection of the surrounding tissue as this material is
opaque. Furthermore wound secretion provides a clear
indication for infection or bleeding as we know by our past
experience of everyday clinical practice. Infection of the
Fig. 2 – Wound documentation by digital photography at postoperative day 2, 4, 6, 8, 10, 12, 14, 16, 24, 48 and after 3 and
6 months.
Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
wound can be confirmed by regarding redness, swelling and
warming of the direct surrounding of the wound. In this case
we decided to remove the dressing and found an infection of
the wound itself in all cases. We evaluated pain of the single
dressing by soft palpation.
The final follow-up examination after 6 months evaluated
the complete healing rate of the wounds. By definition a
wound was declared as ‘healed’, in cases of more than 90% of
wound surface reepithelialization.
2.6. Statistical analysis
We used Microsoft Excel (2013, Microsoft, USA) to manage
data and design the charts. Prior analysis data were checked
for completeness and accuracy checks were conducted. Final
analysis was performed with SPSS (IBM, USA) Version 21.
The time period from day 2 through day 16 was considered
as a statistically relevant period. The donor site of each patient
was covered with the three wound dressings, Biobrane1,
Dressilk1 and PolyMem1. Every second day the dressings
were evaluated regarding to (1) the intensity of pain as
reported by the patients, (2) interpretation capacity, (3) active
bleeding, (4) exuding of the wound and (5) inflammation
starting at the second postoperative day until day 16. In case
that a single assessment was missing, the missing value was
replaced by the previous value (this occurred in <2% of all
values).
Firstly, we calculated mean values based on all patients for
the eight different timepoints (postoperative day 2, 4, 6, 8, 10,
12, 14, and 16) and five items for any single dressing (Table 1).
Secondly in order to reduce the number of values we
calculated one item as the sum of all eight different timepoints
(postoperative day 2, 4, 6, 8, 10, 12, 14, and 16) for each patient,
dressing and item. Since the timepoints had an equal distance
this value is similar to the area under the curve. To create an
average value per patient and we divide this value by eight
timepoints. Thirdly the average mean value over all patients
and the standard deviation of the average mean value within
these three groups (Biobrane1, Dressilk1 and PolyMem1) is
calculated. The results are shown in Table 2. Finally the overall
p value based on Friedman’s test for three groups (Biobrane1,
Dressilk1 and PolyMem1) has been generated. Since the
overall p value is <0.05 we calculated the p value based on
JBUR-4555; No. of Pages 11

burns xxx (2015) xxx–xxx 5

Table 1 – Results for pain, interpretation capacity, active bleeding, exuding of the wound and inflammation: average
values for each timepoint and each type of dressing.
2 4 6 8 10 12 14 16
Pain B 6.36 6.50 6.05 4.73 4.36 3.77 3.36 2.95
P 6.32 6.32 5.86 4.59 4.18 3.59 3.36 2.82
S 6.36 6.41 5.91 4.73 4.09 3.50 3.05 2.82

Exudation B 1.00 1.00 1.00 1.04 1.04 1.00 1.04 1.00

P 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00
S 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00

Inflammation B 1.00 1.00 1.04 1.11 1.11 1.29 1.75 1.57

P 1.17 1.54 1.71 1.71 1.42 1.41 1.48 1.15
S 1.00 1.00 1.00 1.00 1.00 1.00 1.04 1.25

Transparency B 7.75 7.68 7.64 7.07 6.96 6.75 6.64 6.41

P 1.13 1.08 1.00 1.00 1.00 1.00 1.00 1.00
S 8.07 7.89 7.18 5.96 5.25 4.46 4.00 3.61

Exudation B 2.86 2.86 2.50 2.25 2.00 1.86 2.18 2.04

P 4.00 4.39 4.50 4.00 3.57 2.89 2.29 1.82
S 2.61 2.61 2.21 1.89 1.68 1.50 1.32 1.14

Wilcoxon signed rank sum test. These results are presented in noticed in all three dressing materials. We calculated the
Table 3. Statistical significance was accepted at p-values <0.05. average value for all five variables for the first 16 postoperative
days (Table 1).

3. Results 3.2. Results for pain, acute bleeding, exudation,

3.1. Research group characteristics
A total of 34 patients were assessed for eligibility whereas six
patients were excluded (two patients declined taking part in
the study, 4 patients did not meet the inclusion criteria). A
total number of 28 patients could be finally enrolled in the
study. All 28 patients completed the trial and passed the follow
up investigation. Therefore there were no dropouts for the
study. Study data was found to be complete for all enrolled
patients (Fig. 3). All participants were strictly examined as
required by the case report form during hospitalization.
Eight patients were female, 20 patients were male. Their
ages ranged from 21 to 82 years (mean 55 years). All patients
were treated after burn. The average total burned body
surface area ranged from 4% to 70% (mean 19.7%; including
second and third grade burns). 50% of the included patients
suffered from inhalation trauma (first grade to second grade)
and 60% were smokers. No patient was excluded from the
study (Fig. 3).
All patients accomplished donor-site healing prior post-
operative day 24. We could not record complicated or
prolonged healing periods in any patient or dressing-type.
Full re-epithelialization and stable scar conditions were
interpretation capacity and inflammation and adverse events
Concerning pain levels, there were no significant differences
for the three materials used during the first 16 days of
treatment. The maximum level of pain occurred on postoper-
ative day 4 (VRS: Biobrane1 6.50, PolyMem1 6.32, Dressilk1
6.41 of 10). During the following days the pain level declined
equally for all three dressings with the least amount of pain
at postoperative day 16 (VRS: Biobrane1 2.95, PolyMem1
2.82, Dressilk1 2.82 of 10) (Tables 1–3 and Fig. 4).
We found that all three dressings were statistically equal in
terms of acute bleeding. One incident of acute bleeding was
found in patient number 9 at postoperative days 8, 10 and
14 in a small part of the wound covered with Biobrane1. In all
other subjects covered with Biobrane1 we found no signs of
bleeding during the first 16 postoperative days. However,
we did not observe any bleeding in the areas covered with
Dressilk1 or PolyMem1 (Tables 1–3).
Regarding wound exudation rates Biobrane1 and Dressilk1
significantly outclassed PolyMem1. Biobrane1 was superior to
Dressilk1 in wound exudation. The maximum level of exuding
could be found at postoperative day 6 for PolyMem1 (VRS:
maximum 4.50 of 10), at postoperative day 2 for Biobrane1
(VRS: maximum 2.86 of 10) and at postoperative day 2 and 4 for

Table 2 – Calculated over all patients and time points: average value for each type of dressing and standard deviation.
Biobrane PolyMem Dressilk

Mean Standard deviation Mean Standard deviation Mean Standard deviation

Pain 4.76 1.21 4.63 1.2 4.61 1.08
Interpretation capacity 7.12 1.66 1.03 0.17 5.8 1.86
Bleeding 1.01 0.071 1 0 1 0
Exudation 2.31 0.93 3.43 1.35 1.87 0.58
Inflammation 1.23 0.48 1.48 0.95 1.04 0.17

Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
JBUR-4555; No. of Pages 11

6 burns xxx (2015) xxx–xxx

Table 3 – Comparison between the three dressings with respect to pain, inflammation, exudation, interpretation capacity
and bleeding: overall p value based on Friedman’s test for three groups, pairwise comparisons based on Wilcoxon rank
sum test for paired data.
Overall Biobrane/Dressilk Biobrane/PolyMem PolyMem/Dressilk
Pain 0.076 – – –
Interpretation capacity <0.001 0.002 <0.001 <0.001
Bleeding 0.370 – – –
Exudation <0.001 <0.001 <0.001 <0.001
Inflammation 0.015 0.028 0.086 0.007

Dressilk1 (VRS: maximum 2.61). In the following days we
noticed a rapid decrease of exudation rates for all three
dressings (VRS: Biobrane1 2.04, PolyMem1 1.82, Dressilk1 1.14
of 10) (Tables 1–3 and Fig. 5).
Analyzing the transparency level of wounds while covered
by the three dressings, we found a clear and significant benefit
for both Biobrane1 and Dressilk1 over PolyMem1 during
the first 16 study days. PolyMem1 is an opaque totally
non-transparent material. Interpretation of the wound was
managed by evaluation of the surrounding tissue (VRS: 1 of 10).
Biobrane1 and Dressilk1 offered excellent translucence levels
with a maximum at postoperative day 2 (VRS: Biobrane1 7.75
of 10 and Dressilk1 8.07 of 10). In the first postoperative days
the transparency levels were stable at a high level for both
dressings but Dressilk1 significantly decreased after postop-
erative day 6, while the wound became dry. At postoperative
day 16 the interpretation capacity covering a dry wound was
still good for Biobrane1 (VRS: 6.41 of 10) and sufficient for
Dressilk1 (VRS: 3.61 of 10). Biobrane1 was therefore superior
to Dressilk1 in wound interpretation capacity regarding the
full length of the study (Tables 1–3 and Fig. 6).
Regarding the aspect of inflammation rates in 14 patients’
mild signs of infection (i.e. exudation, swelling and redness)
were recorded. In three of these cases (patient three at
postoperative day 16, patient eleven at postoperative day 8 and
patient 17 at postoperative day 16) the infection spread
primarily from the wound area covered with Biobrane1. Ten
patients presented mild signs of infection arising primarily
from the area covered with PolyMem1. In one single case
infection was noted in a wound zone covered with Dressilk1.
When we found signs of a full-blown acute local inflammation
(pus or swelling and hyperthermia), we removed the wound
dressing, used a disinfectant wound flushing, and covered the
wound with greased gauze, as well as a disinfectant dressing.
In summary, it can be noted that throughout the entire trial
Biobrane1 and Dressilk1 were superior to PolyMem1. Fur-
thermore donor sites covered with Dressilk1 presented with
lower infection rates than those covered with Biobrane1
(Fig. 7, Tables 2 and 3).

4. Discussion

Even though a large number of new wound dressing

Fig. 3 – CONSORT flow diagram of the progress presented
through the phases of the randomized trial.
biomaterials have entered the market [4,36], the ideal dressing
material for covering the donor site of partial-thickness skin
grafts has not yet been developed [37]. In clinical practice, the
donor site treatment often means a massive burden for
patients suffering from daily and painful dressing changes,
risk of inflammation, wound exudation and discomfort with
immobility. Therefore, the treatment of the donor site often
leads to an increase in need of pain medication, prolonged
hospital periods and reduction of cost-effectiveness [5,37–40].
The aim of our study was to identify the ‘‘ideal’’ wound
dressing in order to reduce above-mentioned undesirable
aspects in the context of donor site wound management. three
different designed wound dressings to cover split-thickness
skin graft donor sites Biobrane1, Dressilk1 and PolyMem1
were studied in a clinical trial regarding (1) the intensity of
reported pain, (2) dressing and wound transparency with focus
on the level of interpretation capacity, (3) signs of active
bleeding, (4) exudation of the wound and (5) inflammation.

Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
JBUR-4555; No. of Pages 11
burns xxx (2015) xxx–xxx
7
Verbal Rang Scale (1-10)
6
5
4
3
2
1
2 4
Fig. 4 – Average pain levels for the three wound dressing BiobraneW, DressilkW and PolyMemW presented as a function of
postoperative day.
Many previous studies deal with materials and methods
regarding their potential and usefulness in the treatment of
partial and full thickness donor region wounds. Hermanns
used an internet survey to poll directors of burn centers
around the world on their preferences for local treatment of
different types of burns and donor sites [41]. He concluded that
Biobrane1 and PolyMem1 are both suitable dressings for the
management of split-thickness skin graft donor sites [18].
However, comparison studies against the most common
wound dressing used in clinical practice so far (e.g. Duoderm1
(ConvaTec, Germany) [26,42], gauze dressing [26], silver
sulfadiazine [25], Beta Glucan Collagen [20], topical antimi-
crobials and dressing changes [23], Scarlet red1 (Covidien,
Ireland) [43], Suprathel1 (Polymedics Innovations GmbH (PMI))
[29]) are available. Still, recent publications lack any study
directly comparing several dressing options against one
another.
Dressilk1 – has not been used in the present utilized design
by any medical institution yet. Nevertheless, wound dressings
containing silk in different variations are well known. Silk
material has been compared against common dressings of the
recent past (e.g. Tegaderm1 tape (3M, Germany), Tegaderm1
hydrocolloid dressing (3M, Germany) [4], porcine a cellular
dermal matrix (PADM) [44], Bactigras1 (Smith & Nephew,
United Kingdom) [45]). However, Dressilk1 in its present
5
Verbal Rang Scale (1-10
1
2 4
Fig. 5 – Average exudation levels for the three wound dressing BiobraneW, DressilkW and PolyMemW presented as a function
of postoperative day.
Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
7
pain
6 8 10 12 14 16
Postoperave day
B P S
composition has not been compared against Biobrane1 and
PolyMem1 in any study so far.
Pain control is an extremely important aim in wound
therapy. Reduced analgesic medication will provide early
functional recovery and hospital discharge. Therefore, the
perception of pain has received a great influence on treatment
costs [21]. Biobrane1 once applied on the wound provides a
vapor and bacterial barrier, while the wound remains clean
with a reduction in pain. Therefore, it uses less frequent
dressing changes and results in less daily pain as sensory
nerve terminals are covered [20,21,25,43,46]. Biobrane1 dres-
sings are very popular in the therapy of burned children [42].
Lesher et al. found that the rate for non-adherence of
Biobrane1 at first dressing change to be very low with 2%
and 5.6% of patients in their study group [20,23]. Due to the
non-adherence of the dressing to the wound and to the moist
wound environment [17], PolyMem1 is reported to reduce pain
compared against different common dressing [3,16]. The
application of a polymeric membrane in a rodent model leads
to a clear reduction of mechanical and thermal hyperalgesia.
Inflammatory response reduction at the wound site has been
reported to provide pain reduction [15,38]. Wound dressings
containing silk material are even found to reduce pain at the
donor site, compared against common wound dressings [45].
In our study with adult patients we found no significant
exudaon
6 8 10 12 14 16
Postoperave day
B P S
JBUR-4555; No. of Pages 11

8 burns xxx (2015) xxx–xxx

interpretaon capacity
9

Verbal Rang Scale (1-10)

7

1
2 4 6 8 10 12 14 16
Postoperave day

B P S

Fig. 6 – Average of interpretation capacity for the three wound dressing BiobraneW, DressilkW and PolyMemW presented as a
function of postoperative day.

difference in the level of pain throughout the whole study
period. Patients complained about high levels of pain during
the first days of their treatment (VRS: maximum Biobrane1
6.50 of 10, PolyMem1 6.32 of 10, Dressilk1 6.41 of 10 at
postoperative day 2) and equal pain relief levels for all three
dressings afterwards. In summary, we would not prefer any
of the dressing material to the others regarding the level
of potential pain reduction.
Active bleeding is a common reason for wound dressing
‘‘failure’’ and additional dressing changes may lead to pain
and additional material expenses. Biobrane1 cements to the
wound by sanguineous clots and leads to a reduction of
bleeding comparable to adrenalin tumescence [21]. No
significant difference of acute bleeding between the three
dressings has been recorded. The incident of acute bleeding
was just found in one patient on a small part of the wound
covered with Biobrane1. We could not find any bleeding in the
area covered with Silk1 Dressilk1 or PolyMem1 and neither
the patient’s history nor the coagulation diagnostic showed
any dysfunction of blood clotting. Therefore we assumed that
a small cutaneous vessel was mechanically damaged while
changing the Biobrane1 dressing cover. In respect to acute
bleeding we conclude the three dressings as being equivalent.
Exuding of the wound may benefit from higher frequencies
of dressing changes. Studies show that Biobrane1 cements dry
on the wound with a low risk of no adherence [20,21]. In the
present study, it seems that the Dressilk1 barrier also acts in
the same way: we noticed a low risk of adherence and less
dressing changes for both dressings. PolyMem1 covers the
wound to create a moist wound environment [9,14–17]. In our
study PolyMem1 caused a significant higher level of exuding
compared to Biobrane1 and Dressilk1. While they presented
with a low level of exuding in the first postoperative days (VRS:
maximum Biobrane1 2.86 of 10 and Dressilk1 2.61 of 10 at
postoperative day 2 and 4) we recognized increasing droughts
afterwards. In contrast to this development PolyMem1
showed a significant higher level of wound exuding (VRS:
maximum 4.50 of 10 at postoperative day 6) and started drying
out later (VRS: 2.29 of 10 at postoperative day 14). Based on
these observations we changed the external dressing on
a daily basis to increase patientś comfort. Regarding the
aspect of vapor transmission characteristics, we clearly
preferred Biobrane1 and Dressilk1 over PolyMem1. Using
these 2 dressings we were able to save time during daily
wound care, optimize patients’ comfort and mobility, re-gain
early functional recovery with reduced length of hospital stay.
Wound inflammation may lead to complete failure of
the dressing material with an increase in demand for pain
medication, daily dressing changes and in some cases
antibiotic medication – in severe cases even revisional surgery

inflammaon
2
Verbal Rang Scale (1-10)

1
2 4 6 8 10 12 14 16
Postoperave day

B P S

Fig. 7 – Average of inflammation for the three wound dressing BiobraneW, DressilkW and PolyMemW presented as a function
of postoperative day.

Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
JBUR-4555; No. of Pages 11
burns xxx (2015) xxx–xxx
with necrosectomy may become necessary leading to pro-
longed hospital stay and increased treatment costs. Studies
focusing on infection rates using Biobrane1 report contro-
versal results. McHugh et al. and Al et al. reported no increase
in infection rates using Biobrane1 while covering burn
wounds and donor sites compared against common dressing
materials [23,47]. In contrast to these findings, some groups
identified a significant higher incidence of infection, up to 57%,
and do not recommend Biobrane1 on a regular basis as a skin
graft donor site dressing [26,43]. Therefore Rogers et al.
restricted the use of Biobrane1 to the first 48 h after the burn.
They found that the incidence of infection escalated dramati-
cally after this period of time in children with facial burns [28].
Analyzing the risk of infection on wounds covered with
PolyMem1 in 800 cases Jeremy et al. presented a significant
decrease in infection rates on graft donor sites compared
against common dressings [16]. In contrast some other groups
found different wound dressings to be clearly superior to
PolyMem1 regarding their wound infection rates [9,48,49].
Studies analyzing dressings containing silk in different forms
of dressing materials found a low level of infection risk for
these dressing [33,45,50].
Our study revealed significant differences (p < 0.05) in
inflammation rates comparing the three dressings against
each other. We found Dressilk1 to be clearly superior
compared to Biobrane1 and both dressings superior compared
to PolyMem1. Infections associated with Biobrane1 were
found at late stages starting after postoperative day 10 (VRS:
maximum 1.75 of 10 at postoperative day 14) whereas wound
infection associated with PolyMem1 started earlier with
even higher rates after day 2 (VRS: maximum 1.71 of 10 at
postoperative day 6). Mild signs of infection (exudation,
swelling) were found in 13 patients. In three cases (patient
three at postoperative day 16, patient eleven at postoperative
day 8, patient 17 at postoperative day 16) infection spread
primarily from the area covered with Biobrane1. In these
cases the infection did not spread to adjacent areas with
neighboring wounds. Ten patients presented mild signs of
infection arising primarily from the area covered with
PolyMem1. In these cases we recorded the incidence of
infection much earlier, mainly within the first ten postopera-
tive days. In 7 cases the infection spread out to the
surrounding areas covered with Biobrane1. In one single case
infection spread into a neighboring wound area covered with
Dressilk1. The infection in this case did not spread into
the area covered with Biobrane1. There was no infection
associated primarily with Dressilk1 covered wounds. Regard-
ing infection, we share the prevailing opinion in literature and
found several incidents of infection in wound areas covered
with Biobrane1 and PolyMem1 in our study group spreading
to surrounding wound areas. Therefore we clearly prefer
Dressilk1 in regards to this point, as we found no infection
associated primarily with Dressilk1.
Since PolyMem1 is an opaque material we included the
surrounding tissue in our wound evaluation process as we
routinely do in our daily clinical practice. Any infection of
the wound can be suspected by observation of signs such as
redness, swelling and warming of the direct surrounding of
the wound. In this case we decided to remove the dressing and
confirmed in all cases an infected wound itself. In the first six
Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016
9
postoperative days Biobrane1 and Dressilk1 allowed excellent
wound evaluation being nearly transparent during this time.
During the process of drying out both dressings became lesser
transparent. In comparison Biobrane1 – even in a total dry
state – still allowed good wound evaluation while preserving
a high level of transparency. After postoperative day 6 the
transparency of Dressilk1 decreased fast but provided a
sufficient level of wound interpretation. In regards to
interpretation capacity of the wound, Biobrane1 was signifi-
cantly superior to Dressilk1 after postoperative day 6. In this
context, we personally prefer Biobrane1 and Dressilk1 at the
same levels. In our clinical practice close wound monitoring
remains of high relevance to recognize and handle cases high
risk of infection early. Infection mainly took place when the
wound was wet. In these instances both dressings allowed
excellent monitoring and salvage options.
Regarding economic aspects PolyMem1 was the most
inexpensive and Biobrane1 the most costly dressing utilized
in our study. In the case of Dressilk1 unfortunately we do not
have its official market price in its existing design yet. On
demand, the producer provided information about the market
price, ranging somewhat in the middle between PolyMem1
and Biobrane1. Therapy costs are fundamental aspects for
choosing dressing materials in a clearly competitive environ-
ment of hospital care today. In summary, whether we prefer
Dressilk1 over Biobrane1 in our institution, which were both
found to be the superior dressing materials in our study, will
clearly be based on the final therapy cost.
5. Conclusion
With regard to healing and wound epithelialisation after
6 months, pain and acute bleeding, all three dressings
presented equivalent results. Dressilk1 and Biobrane1 were
clearly superior to PolyMem1 in terms of wound assessment
and monitoring, of exudation and the reduction of mild
inflammation rates. Patients were very satisfied because of
the high level of mobility and comfort these two dressings
offered. While monitoring the wound during a prolonged
period, Biobrane1 outperformed Dressilk1 by being even more
transparent. Regarding inflammation and infection rate,
Dressilk1 appears to be more efficient than the two other
dressings in our short study. The comparison of treatment
costs revealed PolyMem1 and Dressilk1 to be superior to
Biobrane1. Finally, based on our presented experience,
together with our wound specialists and patients’ perceptions,
we feel it would be valuable to consider a multicenter
prospective trial with a larger patient population. In the
meantime, we will continue using polymeric membrane
dressings as our first line choice deliberating their lower costs
and good wound healing performance.
Acknowledgements
The authors and investigators have no financial interest in the
trial results. PREVOR was not involved in the study design, nor
in the collection or analysis or interpretation of the data,
which did impartial professionals perform.
JBUR-4555; No. of Pages 11
10 burns xxx (2015) xxx–xxx
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Please cite this article in press as: Schulz A, et al. A prospective clinical trial comparing Biobrane1 Dressilk1 and PolyMem1 dressings on partial-
thickness skin graft donor sites. Burns (2015), http://dx.doi.org/10.1016/j.burns.2014.12.016