Efficacy of Hydrocolloid Dressing vs. Topical Antibiotic on Wound Healing of Post-Punch Biopsy Wounds

NCT ID: NCT07064161

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2024-10-07

Brief Summary

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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.

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.

The primary outcome measure is the proportion of patients who achieved better overall healing when treated with hydrocolloid dressing.

Detailed Description

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Conditions

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Biopsy Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hydrocolloid Dressing

Skin punch biopsy wound treated with hydrocolloid dressing.

Group Type EXPERIMENTAL

Hydrocolloid Dressing (DuoDERM CGF)

Intervention Type DRUG

Wounds were dressed with a 1-inch size Duoderm Control Gel Formula hydrocolloid dressing

Topical Antibiotic

Skin punch biopsy wound treated with topical antibiotic.

Group Type EXPERIMENTAL

Mupirocin (drug)

Intervention Type DRUG

Wounds were dressed with gauze impregnated with mupirocin ointment covered by a transparent dressing (Tegaderm)

Interventions

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Mupirocin (drug)

Wounds were dressed with gauze impregnated with mupirocin ointment covered by a transparent dressing (Tegaderm)

Intervention Type DRUG

Hydrocolloid Dressing (DuoDERM CGF)

Wounds were dressed with a 1-inch size Duoderm Control Gel Formula hydrocolloid dressing

Intervention Type DRUG

Other Intervention Names

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Mupirocin ointment Antimicrobial Topical antibacterial hydrocolloid

Eligibility Criteria

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Inclusion Criteria

* Adult patients 18 to 64 years old with clean cutaneous lesions who underwent skin punch biopsy using 3-mm disposable biopsy puncher.

Exclusion Criteria

* Patients with infected wounds.
* Patients with conditions with poor tendency to heal including diabetes mellitus, peripheral vascular disease, history of keloid formation, patients currently receiving anticoagulation therapy or systemic corticosteroids.
* Patients known to have hypersensitivity to topical antibiotics.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Santo Tomas Hospital, Philippines

OTHER

Sponsor Role lead

Responsible Party

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Fiona Bianca V. Enriquez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Santo Tomas Hospital

Manila, National Capital Region, Philippines

Site Status

Countries

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Philippines

References

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17. World Health Organization. Antimicrobial resistance. World Health Organization. Published November 21, 2023. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance

Reference Type BACKGROUND

Armstrong RB, Nichols J, Pachance J. Punch biopsy wounds treated with Monsel's solution or a collagen matrix. A comparison of healing. Arch Dermatol. 1986 May;122(5):546-9.

Reference Type BACKGROUND
PMID: 3707170 (View on PubMed)

Holmes SP, Rivera S, Hooper PB, Slaven JE, Que SKT. Hydrocolloid dressing versus conventional wound care after dermatologic surgery. JAAD Int. 2021 Dec 21;6:37-42. doi: 10.1016/j.jdin.2021.11.002. eCollection 2022 Mar.

Reference Type BACKGROUND
PMID: 34993497 (View on PubMed)

Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. doi: 10.1016/j.clindermatol.2006.09.007.

Reference Type BACKGROUND
PMID: 17276196 (View on PubMed)

Schmitt M, Vergnes NP, Canarelli JP, Gailhrd S, Daoud S, Dodat H, Lascombes P, Melin NY, Morisson-Lacombe G, Revillon Y. Evaluation of a hydrocolloid dressing. J Wound Care. 1996 Oct 2;5(9):396-399. doi: 10.12968/jowc.1996.5.9.396.

Reference Type BACKGROUND
PMID: 27935418 (View on PubMed)

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. J Accid Emerg Med. 1994 Dec;11(4):227-30. doi: 10.1136/emj.11.4.227.

Reference Type BACKGROUND
PMID: 7894807 (View on PubMed)

Wright A, MacKechnie DW, Paskins JR. Management of partial thickness burns with Granuflex 'E' dressings. Burns. 1993 Apr;19(2):128-30. doi: 10.1016/0305-4179(93)90034-6.

Reference Type BACKGROUND
PMID: 8471145 (View on PubMed)

Hermans MH, Hermans RP. Preliminary report on the use of a new hydrocolloid dressing in the treatment of burns. Burns Incl Therm Inj. 1984 Dec;11(2):125-9. doi: 10.1016/0305-4179(84)90135-9.

Reference Type BACKGROUND
PMID: 6395938 (View on PubMed)

Hulten L. Dressings for surgical wounds. Am J Surg. 1994 Jan;167(1A):42S-44S; discussion 44S-45S. doi: 10.1016/0002-9610(94)90010-8.

Reference Type BACKGROUND
PMID: 8109684 (View on PubMed)

Michie DD, Hugill JV. Influence of occlusive and impregnated gauze dressings on incisional healing: a prospective, randomized, controlled study. Ann Plast Surg. 1994 Jan;32(1):57-64. doi: 10.1097/00000637-199401000-00011.

Reference Type BACKGROUND
PMID: 8141537 (View on PubMed)

Estienne G, Di Bella F. [The use of DuoDerm in the surgical wound after surgical treatment of pilonidal fistulae using the open method]. Minerva Chir. 1989 Oct 15;44(19):2089-92. Italian.

Reference Type BACKGROUND
PMID: 2616009 (View on PubMed)

Viciano V, Castera JE, Medrano J, Aguilo J, Torro J, Botella MG, Toldra N. Effect of hydrocolloid dressings on healing by second intention after excision of pilonidal sinus. Eur J Surg. 2000 Mar;166(3):229-32. doi: 10.1080/110241500750009339.

Reference Type BACKGROUND
PMID: 10755338 (View on PubMed)

Thomas S. Hydrocolloid dressings in the management of acute wounds: a review of the literature. Int Wound J. 2008 Dec;5(5):602-13. doi: 10.1111/j.1742-481X.2008.00541.x.

Reference Type BACKGROUND
PMID: 19134061 (View on PubMed)

Demidova-Rice TN, Hamblin MR, Herman IM. Acute and impaired wound healing: pathophysiology and current methods for drug delivery, part 1: normal and chronic wounds: biology, causes, and approaches to care. Adv Skin Wound Care. 2012 Jul;25(7):304-14. doi: 10.1097/01.ASW.0000416006.55218.d0.

Reference Type BACKGROUND
PMID: 22713781 (View on PubMed)

Lazarus GS, Cooper DM, Knighton DR, Margolis DJ, Pecoraro RE, Rodeheaver G, Robson MC. Definitions and guidelines for assessment of wounds and evaluation of healing. Arch Dermatol. 1994 Apr;130(4):489-93.

Reference Type BACKGROUND
PMID: 8166487 (View on PubMed)

Mendonca RJ, Coutinho-Netto J. Cellular aspects of wound healing. An Bras Dermatol. 2009 Jul;84(3):257-62. doi: 10.1590/s0365-05962009000300007. English, Portuguese.

Reference Type BACKGROUND
PMID: 19668939 (View on PubMed)

Ramsey ML, Conrad E, Chen RL, Rostami S. Skin Biopsy. 2025 Sep 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470457/

Reference Type BACKGROUND
PMID: 29262109 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2023-06-047-TR-AP

Identifier Type: -

Identifier Source: org_study_id

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