A Double-Blind Randomized Controlled Trial on the Efficacy of Hydrocolloid Dressing vs. Topical Antibiotic on Wound Healing of Post-Punch Biopsy Wounds Among Patients in a Tertiary Hospital in Manila
Phase: NA
Conditions: Biopsy Wound
Sponsor: University of Santo Tomas Hospital, Philippines

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 1 of 22 
 
 
 
 
 
 
A Double-Blind Randomized Controlled Trial on the Efficacy of Hydrocolloid 
Dressing vs. Topical Antibiotic on Wound Healing of Post-Punch Biopsy 
Wounds Among Patients in a Tertiary Hospital in Manila 
 
 
 
Fiona Bianca Velasco-Enriquez, MD 
Eleanor Lo-Letran, MD, FPDS 
 
 
 
University of Santo Tomas Hospital, España, Manila 
Department of Dermatology 
 
 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 2 of 22 
TITLE:  A Double-Blind Randomized Controlled Trial on the Efficacy of 
Hydrocolloid Dressing vs. Topical Antibiotic on Wound Healing of Post-Punch 
Biopsy Wounds Among Patients in a Tertiary Hospital in Manila 
 
Enriquez, Fiona V., Letran, Eleanor L. 
Resident, Department of Dermatology; Consultant, Department of Dermatology 
 
PROJECT SUMMARY 
 
Rationale:  
 
Objectives: The main objective of this study is to determine the efficacy of using 
hydrocolloid dressing on wound healing of post-punch biopsy wounds vs topical 
antibiotic. Specifically, it aims to measure the following parameters: the presence or 
absence of infection, the clinical estimate of reepithelialization, the clinical estimate of 
wound closure, scar formation, pigmentation of scar, and the cosmetic appearance of 
the wound. 
 
Methodology and Population: The study is a double-blind randomized controlled 
trial which will be conducted at the Dermatology outpatient department and the private 
clinics of dermatology consultants of the University of Santo Tomas Hospital. Patients 
who will be included are those who are 18 to 64 years of age with clean cutaneous 
lesions. Excluded from this study are those who have infected wounds, those who 
have conditions with poor tendency to heal including diabetes mellitus, peripheral 
vascular disease, history of keloid formation, those currently receiving anticoagulation 
therapy or systemic corticosteroids, and those known to have hypersensitivity to 
topical antibiotics. 
 
Time Frame: 6 months 
 
Expected Outcomes: The primary outcome measure is the proportion of patients who 
achieved better overall healing when treated with hydrocolloid dressing. 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 3 of 22 
GENERAL INFORMATION 
PROTOCOL TITLE: 
A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL ON THE 
EFFICACY OF HYDROCOLLOID DRESSING VS. TOPICAL ANTIBIOTIC ON 
WOUND HEALING OF POST-PUNCH BIOPSY WOUNDS AMONG 
PATIENTS IN A TERTIARY HOSPITAL IN MANILA 
 
 
 
 
 
NAME AND ADDRESS OF SPONSOR/FUNDER: 
NOT APPLICABLE 
 
 
 
 
 
 
 
NAME AND ADDRESS OF AUTHORS: 
Fiona Bianca Velasco-Enriquez, MD  
Eleanor Lo-Letran, MD, FPDS  
University of Santo Tomas Hospital, España, Manila 
 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 4 of 22 
BACKGROUND 
Skin biopsies play an essential role in the verification or confirmation of the 
diagnosis of patients with dermatologic disorders. The punch biopsy, one of the 
frequently performed types of skin biopsies, is an incisional method that makes use of 
a cylindrical blade to obtain a specimen with a fuller thickness of the skin as compared 
to a shave biopsy. It is a procedure that has a low-risk of developing surgical site 
infections due to the short operative time and shallow wound depth. The most 
commonly used skin punch sizes range from 2 mm to 6 mm in diameter. Punch 
biopsies of less than 4 mm in size do not need to be closed with sutures. Obtaining an 
adequate tissue sample for histopathologic evaluation while preventing patient 
disfigurement is important.[1] 
Wound healing is a complex biological process where the main goal of clinical 
intervention is the promotion of tissue restoration.[2] Acute wounds are wounds that 
follow a predictable and timely repair process which results in the restoration of 
sufficient anatomical and functional integrity if healing proceeds normally.[3] In the 
pathophysiology of acute wound healing, there are four overlapping phases of the 
normal wound healing process namely coagulation, inflammation, granulation tissue 
formation, and remodeling phase. Neutrophils, macrophages, and platelets provide 
growth factors and provisional matrices that are required for the recruitment of 
epidermal and dermal cells into the wound bed during the coagulation and 
inflammatory phases of healing. The proliferative phase begins 3 days after injury and 
is characterized by increased keratinocyte and fibroblast proliferation, migration, and 
extracellular 
membrane 
synthesis. 
During 
this 
stage, 
angiogenesis 
or 
neovascularization also occurs. The tissue has a granular appearance due to the 
presence of blood vessels (granulation tissue). Finally, 1 to 2 weeks after injury, 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 5 of 22 
differentiated fibroblastic cells (myofibroblasts) present in the granulation tissue begin 
to remodel the extracellular matrix. Acellular scar formation is caused by extracellular 
matrix remodeling followed by apoptosis of resident cells.[4] 
Hydrocolloid is a type of dressing in which a "hydrophilic gelable mass is applied 
in a semisolid form to a flexible semipermeable carrier." Hydrocolloids were originally 
made as small square pieces in 1985. In 1989, a "thin" version was developed wherein 
these dressings have little or no fluid retention ability and are less permeable than the 
standard films and are used as post-operative dressings or as secondary retention 
products over primary dressings. Hydrocolloid dressings are most commonly utilized 
with the treatment of chronic wounds such as leg ulcers and pressure ulcers, however 
they can also be used with good effect for the treatment of a variety of acute wounds 
where their ability to facilitate debridement, absorb excess fluid and provide a barrier 
to infection is equally valuable.[5] 
Locally, in the Philippines, due to high rates of infection, topical antibiotics are 
routinely applied as wound care and prophylaxis despite obtaining clean wounds. In 
this study, we will investigate whether hydrocolloid dressings can be used as a 
treatment modality for the healing and care of post-punch biopsy sites. 
 
 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 6 of 22 
REVIEW OF RELATED LITERATURE 
Surgical Wounds 
In the management of surgical wounds, hydrocolloid dressings have been used 
as primary and secondary dressings for sutured wounds and wounds with secondary 
intention healing.[5] 
The use of hydrocolloids following excision of pilonidal sinuses have been 
reported by Viciano et al. through a prospective randomized trial involving 38 patients 
in which the researchers compared a hydrocolloid (Comfeel with Varihesive/Duoderm) 
and conventional gauze. Median healing time in the control group was 68 days in 
comparison to the experimental group which was 65 days. One-third of the cultures in 
the control group developed pathogens compared with 1 out of 23 patients with the 
hydrocolloid group, however these results were deemed statistically insignificant. Pain 
was assessed as significantly less in the hydrocolloid group in the first four weeks 
post-operation compared with those in the control group in which the conclusion was 
made that the use of hydrocolloid dressings leads to a reduction in pain but no effect 
on healing times.[6] 
A study by Estienne and Di Bella compared Granuflex/Duoderm with traditional 
dressings which made use of hypochlorite irrigation and packing with paraffin gauze 
in 40 patients for pilonidal fistula. The hydrocolloid dressing was first applied on the 
third postoperative day after an iodoform gauze pack was removed which was applied 
in theater. Dressings were changed on alternate days, but was extended to 3-5 days 
later on and results showed that wounds with hydrocolloid dressings had complete 
healing in an average of 6 weeks compared with 10 weeks with the traditional 
dressings.[7] 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 7 of 22 
Michie and Hugill compared Granuflex/Duoderm Extra Thin hydrocolloid 
dressing with an impregnated gauze (Xeroform) in 28 patients with 40 wounds after 
an elective surgery to assess the effects of the dressings on incisional healing. One-
half of every incision was covered with each of the dressings under investigation as 
each patient served as their own control. Wounds were assessed after a period of 2 
to 3 days, 7 to 10 days, 4 weeks, and 7 months postoperatively. No incision showed 
any evidence of infection and during suture removal, hydrocolloid dressings were 
assessed to contain exudate, protect the wound, and facilitate mobility and personal 
hygiene more effectively compared with the impregnated gauze dressing. When 
assessment was done after 4 weeks, scar segments covered with hydrocolloid 
dressings showed better appearance in terms of color, evenness, and suppleness 
compared with the Xeroform gauze, however these differences were no longer 
observed 7 months after the elective surgery.[8] 
A study by Hulten showed that soiling which commonly occurs with wounds 
dressed with traditional gauze were not observed in 89% of 340 patients who had 
undergone colorectal surgery with stoma creation and dressed with hydrocolloid.  The 
study also showed that 92% of the patients studied had no wound infections 
encountered.[9] 
Burns 
 
A report on the use of hydrocolloid dressing in the treatment of burns by 
Hermans and Hermans in 1984 showed that the use of Granuflex/Duoderm in 24 
patients had favorable healing rates compared with those treated with silver 
sulfadiazine cream in both superficial and deep partial thickness burns.[10] 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 8 of 22 
In a study by Wright et al, 67 patients with partial thickness burns managed as 
outpatients were treated with hydrocolloid dressings (Granuflex/Duoderm) versus 
conventional dressing (Bactigras) to compare the two products. The healing time 
(median 12 days) were comparable for both products in this study, however the quality 
of healing was rated “excellent” in 56% of the participants treated with 
Granuflex/Duoderm versus 11% in the group treated with Bactigras. The authors in 
this study suggested to use Granuflex/Duoderm as “first-choice dressing in the 
management of partial skin thickness burns”.[11] 
Traumatic Wounds 
 
A study done by Heffernan and Martin compared Granuflex/Duoderm Extra 
Thin with a perforated film absorbent dressing in managing 96 patients with 
lacerations, abrasions and minor operation incisions. The study showed similar results 
for healing time for both interventions; however, those patients using hydrocolloid 
dressings experienced less pain, required less analgesia, and were able to carry out 
activities of daily living without their wounds getting affected.[12] 
Pediatric Wounds 
 
A study done by Schmitt et al. compared hydrocolloid dressing with adhesive 
skin tapes on post-operative wounds in 170 children. Effective skin closure was 
comparable in both interventions but hydrocolloids were observed to be more secure, 
remaining in place in 69 children compared with adhesive skin tapes.[13] 
 
SIGNIFICANCE OF THE STUDY 
This study can provide a potential option to promote faster healing of post-
operative wounds particularly for skin punch biopsy used in the field of Dermatology. 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 9 of 22 
It will encourage Filipino dermatologists to reduce the routine use of prophylactic 
topical antibiotics as post-biopsy care heralding better antibiotic stewardship practices. 
 
MAIN OBJECTIVE 
The main objective of this study is to determine the efficacy of using 
hydrocolloid dressing on wound healing of non-sutured post-punch biopsy sites in 
comparison to gauze dressing impregnated with topical antibiotics (mupirocin 
ointment) at the Dermatology outpatient department and the private clinics of 
dermatology consultants of the University of Santo Tomas Hospital. 
 
SPECIFIC OBJECTIVES 
Specifically, this study aims to compare the efficacy of hydrocolloid dressing 
after 5 days post-punch biopsy by measuring the following parameters: absence or 
presence of infection, clinical estimate of reepithelialization, clinical estimate of wound 
closure, scar formation, pigmentation of scar and cosmetic appearance of wound. 
 
METHODOLOGY 
A. Study Design 
This is a double blind randomized controlled trial that will be conducted at the 
outpatient department of the University of Santo Tomas Hospital Department of 
Dermatology. Permission letters from the Head of Ambulatory Care Services (ACS), 
the Data Privacy Officer (DPO), and the Medical Director of UST Hospital will be 
obtained prior to the implementation of this study. Permission letters from the USTH 
Dermatology consultants for their private patients will be obtained prior to the 
implementation of this study. 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 10 of 22 
 
Figure 1. Schematic diagram of the study design 
 
 
B. Patient Selection, Recruitment and Withdrawal 
Adult patients 18 to 64 years old with clean cutaneous lesions who will undergo 
skin punch biopsy using a 3-mm disposable biopsy puncher shall be included in the 
study. 
Patients will be recruited from the UST Hospital outpatient department and from 
the private clinics of the UST Hospital Dermatology consultants. Patients who have 
infected wounds, patients who have conditions with poor tendency to heal including 
diabetes mellitus, peripheral vascular disease, history of keloid formation, patients 
currently receiving anticoagulation therapy or systemic corticosteroids, and patients 
known to have hypersensitivity to topical antibiotics shall be excluded from the study. 
Participants may request to withdraw from the study at any time. A participant 
may also be withdrawn from the study if the primary investigator believes that the 
participant was non-compliant with the treatment guidelines or develops severe and 
intolerable adverse effects (e.g. hypersensitivity reaction) secondary to the treatment 
given.  

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 11 of 22 
C. Randomization and Blinding 
Randomization 
Assignment of participants to the experimental (hydrocolloid dressing) or 
control group (topical antibiotic) will be done using the fishbowl method by a research 
assistant. 
Blinding 
Participants and the physician assessors will be blinded with the treatment 
assigned. 
D. Baseline Data Collection 
On the first visit, informed consent will be obtained from the patient. Afterwards, 
the following data will be recorded by the primary investigator on the baseline general 
information sheet: study code assigned to each individual patient, age, sex, and 
anatomic sites involved. 
Photographs will be limited to the skin punch biopsy sites and will be taken at 
baseline using a DSLR camera with uniform distance (3 inches) and lighting. 
On the 5th day after the skin punch biopsy procedure, the following data will be 
recorded by the physician assessors: the presence or absence of infection, the clinical 
estimate of reepithelialization, the clinical estimate of wound closure, scar formation, 
pigmentation of scar, and the cosmetic appearance of the wound. The primary 
investigator will then collect the wound evaluation sheets from the physician 
assessors. Photographs of the biopsy site will also be taken. 
E. Intervention 
Before the biopsies will be performed, the sites will be cleansed with 70% 
isopropyl alcohol and anesthetized intradermally with 1% lidocaine hydrochloride.  

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 12 of 22 
No suture, electrocautery, aluminum chloride or other hemostatic agents will be 
applied to the biopsy sites to avoid inhibition of wound healing inherent with these 
agents. 
Once bleeding will be controlled by pressure, wounds will be dressed with either 
a 1-inch size Duoderm Control Gel Formula hydrocolloid dressing or gauze dressing 
impregnated with mupirocin ointment covered by a transparent dressing (Tegaderm). 
Dressings will be left in place for 5 days, after which the dressings will be removed 
and will be cleansed with water to remove any exudate. 
F. Assessment 
For this study, wound assessment will be done after 5 days. Dermoscopy and 
photographs of the wounds will be taken for every evaluation. 
According to a study entitled “Pathophysiology of Acute Wound Healing” by Jie 
Li, PhD et. al. published in Elsevier Clinics in Dermatology in 2007, there are three 
phases of wound repair that overlap in time. These are the inflammatory reaction 
phase, proliferation phase, and remodeling phase. Days after initial injury, the wound 
would be in the proliferative phase where there would be reepithelialization of the 
wound, the establishment of appropriate blood supply, and reinforcement of the injured 
dermal tissue.[14] 
Three physician assessors who will be trained in the evaluation of skin punch 
biopsy wounds and the scoring criteria that will be used in this study will assess the 
wound and record their evaluations individually. 
 
SAMPLE SIZE AND STATISTICAL ANALYSIS 
 
Using G*Power 3.1.9.7, a minimum of 56 patients or 28 per group are required 
for this study based on the 8.38 mean Scar appearance score on Hydrocolloid 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 13 of 22 
dressing versus 7.23 mean Scar appearance score on Conventional daily dressing.[15] 
This computation also accounts for desired 1.5 common standard deviation, 5% level 
of significance and 80% power. 
 
Descriptive statistics will be used to summarize the demographic and clinical 
characteristics of the patients. Frequency and proportion will be used for categorical 
variables and mean and SD for normally distributed continuous variables. Independent 
Sample T-test and Fisher’s Exact/Chi-square test will be used to determine the 
difference of mean and frequency, respectively, between patients undergoing 
Hydrocolloid Dressing versus Topical Antibiotic. All statistical tests will be two tailed 
tests. Shapiro-Wilk test will be used to test the normality of the continuous variables. 
Missing values will neither be replaced nor estimated. Null hypotheses will be rejected 
at 0.05α-level of significance. STATA 13.1 will be used for data analysis. 
 
Inter-rater and Intra-rater reliability will also be conducted. 
 
SAFETY EVALUATION 
Assessment of possible adverse effects due to the hydrocolloid dressing or the 
topical antibiotics will be done on follow-up visit. Complaints of pruritus, burning, or 
stinging sensation will be asked from participants, while other physical signs and 
symptoms of adverse effects to the treatment applied will be checked by the primary 
investigator. 
 
ETHICAL CONSIDERATIONS 
This study will be conducted in accordance with the accepted ethical research 
practices of the ICH Good Clinical Practice regulations and guidelines. The study will 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 14 of 22 
be explained thoroughly to the eligible patients prior to enrollment. Free and informed 
written consent will be obtained. 
 
INFORMED CONSENT 
All participants involved in the study will not be compromised in terms of 
treatment. All possible benefits and side effects of the treatment will be fully explained 
and must be understood by the patients prior to enrollment into the study.  
The primary investigator will explain the study objectives, procedure, risks, and 
benefits to the eligible patients. Patients will be encouraged to ask questions regarding 
the study. In order to affirm voluntary participation, the patients will be asked to sign a 
written informed consent form (ICF) available in both English and Filipino versions 
(attached separately). One copy of the ICF will be given to the patient for reference. 
Another consent taker will be provided if the participant is a patient of the primary 
investigator. 
 
CONFLICT OF INTEREST 
This study is investigator-initiated and not industry funded or company 
sponsored. There is no potential conflict of interest. 
 
PRIVACY AND CONFIDENTIALITY 
All data will be handled in compliance to the Data Privacy Act of 2012 and its 
implementing rules and regulations in 2016. 
The identity, personal data, and other medical information of patients will 
remain confidential. In the event of any publication regarding the study, the identity of 
the patients will remain confidential. 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 15 of 22 
Physical data will be securely filed and electronic data will be stored in an 
encrypted hard drive by the principal investigator. Both forms of data will be protected 
from illegal or inadvertent access. Only the primary investigators, study coordinators, 
and the statistician will have access to the information collected for this study. 
Physical data will be shredded and securely disposed of one year after the 
completion of this study. Electronic data will be stored for a maximum of three years 
after completion of this study after which all data will be permanently deleted. 
The records, to the extent of the applicable laws and regulations, will not be 
made publicly available. However, the UST Hospital – Research Ethics Committee 
(USTH-REC) will be granted direct access to the participant’s original medical records 
to check study procedures and data, without making any of the information public. The 
informed consent form that patients will sign prior to participation in the study will 
include a section that they are authorizing such access to the study and medical 
records. 
 
VULNERABILITY 
Patients aged 18 years old to 64 years old with clean cutaneous lesions who 
will undergo skin punch biopsy will be recruited in this study. No patients aged below 
18 years old or above 64 years old, prisoners, mentally handicapped, or those with 
incurable diseases will be included. 
 
RISKS 
The possible side effect of hydrocolloid dressing is irritation of the skin. 
Treatment on patients who will experience any adverse side effects will be immediately 
stopped.   

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 16 of 22 
To minimize the risk of COVID-19 exposure, all safety measures in accordance 
with the IATF guidelines will be observed. 
 
BENEFITS 
The benefit that the patient will acquire from this study is better clinical 
outcomes of the post-biopsy site. This study can also help reduce medical costs and 
patients are suggested with alternative options which can be potentially used as one 
of the treatment modalities for post-biopsy sites. 
 
INCENTIVES AND COMPENSATION 
All of the dermatologic consultations and medications of the participants for 
the duration of the study will be free of charge. Transportation allowance of PHP 
100.00 will be provided to the participant on their visit on the 5th day. Management, 
consultation, and treatment of adverse effects resulting from the participation in this 
study will be free of charge. No other form of monetary compensation will be 
provided to the patients for their participation. Patients will be informed of the results 
of the study once it has been completed. 
 
SCORING CRITERIA FOR EVALUATION OF WOUND 
Objective assessment is based on a study by Armstrong et. al. in 1986 entitled 
“Punch biopsy wounds treated with Monsel’s solution or a collagen matrix”.[16] For this 
study, the assessment will be done as follows: 
 
(1) infection (absent, millimeters of surrounding erythema or equivocal findings; 
or present, as inferred by indurated erythema or purulent discharge); 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 17 of 22 
 
(2) clinical estimate of reepithelialization (rated on a scale of (a) 0% to 25%, (6) 
26% to 50%, (c) 51% to 75%, and (d) 76% to 100%); 
 
(3) clinical estimate of wound closure (rated on a scale of (a) 0% to 25%, (b) 
26% to 50%, (c) 51% to 75%, and (d) 76% to 100%) 
(4) scar formation (unhealed; depressed or atrophied; normal fine-line scar; or 
hypertrophied scar or keloid); 
         (5) pigmentation of scar (indeterminate or unhealed; normal; hyperpigmented; 
or hypopigmented); 
(6) cosmetic appearance of wound (acceptance of patient: indeterminate or 
unhealed; poor; fair; good; excellent) 
 
 
 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 18 of 22 
DUMMY TABLES 
Table 1. 
Baseline demographic and clinical characteristics 
 
Total 
Hydrocolloid 
Dressing 
Topical 
Antibiotic 
P-value 
Frequency (%); Mean + SD 
Age, years 
 
 
 
 
Sex 
Male 
Female 
 
 
 
 
Indications for Skin 
Punch Biopsy 
 
 
 
 
… 
 
 
 
 
 
Table 2. 
Scoring Criteria for Evaluation of Wound 
 
Total 
Hydrocolloid 
Dressing 
Topical 
Antibiotic 
P-value 
Frequency (%) 
Infection 
Absent 
Present 
 
 
 
 
Re-epithelialization estimate 
0 to 25% 
26 to 50% 
51 to 75% 
76 to 100% 
 
 
 
 
Wound closure 
0 to 25% 
26 to 50% 
51 to 75% 
76 to 100% 
 
 
 
 
Scar Formation 
Unhealed 
 
 
 
 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 19 of 22 
Depressed or Atrophied 
Normal Fine-Line Scar 
Hypertrophied Scar or 
Keloid 
Scar Pigmentation 
Indeterminate or Unhealed 
Normal 
Hyperpigmented 
Hypopigmented 
 
 
 
 
Cosmetic Appearance 
Indeterminate or Unhealed 
Poor 
Fair 
Good 
Excellent 
 
 
 
 
 
 
 
 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 20 of 22 
REFERENCES 
1. Ramsey ML, Rostami S. Skin Biopsy. In: StatPearls. Treasure Island (FL): 
StatPearls Publishing; September 9, 2022. 
2. Mendonça RJ de, Coutinho-Netto J. Cellular aspects of wound healing. Anais 
Brasileiros de Dermatologia. 2009;84(3):257-262. 
doi:https://doi.org/10.1590/s0365-05962009000300007 
3. Lazarus GS. Definitions and Guidelines for Assessment of Wounds and 
Evaluation of Healing. Archives of Dermatology. 1994;130(4):489. 
doi:https://doi.org/10.1001/archderm.1994.01690040093015 
4. Demidova-Rice TN, Hamblin MR, Herman IM. Acute and Impaired Wound 
Healing. Advances in Skin & Wound Care. 2012;25(7):304-314. 
doi:https://doi.org/10.1097/01.asw.0000416006.55218.d0 
5. Thomas S. Hydrocolloid dressings in the management of acute wounds: a 
review of the literature. International Wound Journal. 2008;5(5):602-613. 
doi:https://doi.org/10.1111/j.1742-481x.2008.00541.x 
6. Viciano, José E. Castera, J V. Effect of Hydrocolloid Dressings on Healing by 
Second Intention after Excision of Pilonidal Sinus. The European Journal of 
Surgery. 2000;166(3):229-232. 
doi:https://doi.org/10.1080/110241500750009339 
7. Estienne G, Bella D. L’impiego del “DuoDerm” nella ferita operatoria dopo 
trattamento chirurgico delle fistole pilonidali col metodo aperto [The use of 
DuoDerm in the surgical wound after surgical treatment of pilonidal fistulae 
using the open method]. Minerva Chir. 1989;44(19):2089-2092. 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 21 of 22 
8. Michie DD, Hugill JV. Influence of Occlusive and Impregnated Gauze 
Dressings on Incisional Healing. Annals of Plastic Surgery. 1994;32(1):57-64. 
doi:https://doi.org/10.1097/00000637-199401000-00011 
9. Hultén L. Dressings for surgical wounds. The American Journal of Surgery. 
1994;167(1A):S42-S45. doi:https://doi.org/10.1016/0002-9610(94)90010-8 
10. Hermans MHE, Hermans RP. Preliminary report on the use of a new 
hydrocolloid dressing in the treatment of burns. Burns Incl Therm Inj. 
1984;11(2):125-129. doi:https://doi.org/10.1016/0305-4179(84)90135-9 
11. Wright A, MacKechnie DWM, Paskins JR. Management of partial thickness 
burns with Granuflex “E” dressings. Burns. 1993;19(2):128-130. 
doi:https://doi.org/10.1016/0305-4179(93)90034-6 
12. Heffernan A, Martin AJ. A comparison of a modified form of Granuflex 
(Granuflex Extra Thin) and a conventional dressing in the management of 
lacerations, abrasions and minor operation wounds in an accident and 
emergency department. Emergency Medicine Journal. 1994;11(4):227-230. 
doi:https://doi.org/10.1136/emj.11.4.227 
13. Schmitt M, Vergnes N P., Canarelli JP, et al. Evaluation of a hydrocolloid 
dressing. Journal of Wound Care. 1996;5(9):396-399. 
doi:https://doi.org/10.12968/jowc.1996.5.9.396 
14. Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clinics in 
dermatology. 2007;25(1):9-18. 
doi:https://doi.org/10.1016/j.clindermatol.2006.09.007 
15. Holmes SP, Rivera S, Hooper PB, Slaven JE, Que SKT. Hydrocolloid 
dressing versus conventional wound care after dermatologic surgery. JAAD 
International. 2021;6:37-42. doi:https://doi.org/10.1016/j.jdin.2021.11.002 

Amended Protocol Version No. 01 dated 25 July 2024  
     
    Page 22 of 22 
16. Armstrong RB. Punch Biopsy Wounds Treated With Monsel’s Solution or a 
Collagen Matrix. Archives of Dermatology. 1986;122(5):546. 
doi:https://doi.org/10.1001/archderm.1986.01660170076023