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

NCT07064161 | Completed

• 1 other identifier: 2023-06-047-TR-AP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biopsy Wound

Keywords

Biopsy; Wound Healing; Bandages, Hydrocolloid; Dermatology; Anti-Bacterial Agents

Outcome Measures

Primary Outcomes (6)

• Absence or Presence of Infection

  Absent - millimeters of surrounding erythema or equivocal findings Present - as inferred by indurated erythema or purulent discharge

  5 days after punch biopsy.

• Clinical Estimate of Reepithelialization

  Rated on a scale of: * 0% to 25% * 26% to 50% * 51% to 75% * 76% to 100%

  5 days after punch biopsy

• Clinical Estimate of Wound Closure

  Rated on a scale of: * 0% to 25% * 26% to 50% * 51% to 75% * 76% to 100%

  5 days after punch biopsy

• Scar Formation

  Select one of the following for the assessment: * Unhealed * Depressed or Atrophied * Normal fine-line scar * Hypertrophied scar or Keloid

  5 days after punch biopsy

• Scar Pigmentation

  Select one of the following for the assessment: * Indeterminate or Unhealed * Normal * Hyperpigmented * Hypopigmented

  5 days after punch biopsy

• Cosmetic Appearance

  Select one of the following for the assessment: * Indeterminate or Unhealed * Poor * Fair * Good * Excellent

  5 days after punch biopsy

Study Arms (2)

Hydrocolloid Dressing

EXPERIMENTAL

Skin punch biopsy wound treated with hydrocolloid dressing.

Drug: Hydrocolloid Dressing (DuoDERM CGF)

Topical Antibiotic

EXPERIMENTAL

Skin punch biopsy wound treated with topical antibiotic.

Drug: Mupirocin (drug)

Interventions

Mupirocin (drug) DRUG

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

Also known as: Mupirocin ointment, Antimicrobial, Topical antibacterial

Topical Antibiotic

Hydrocolloid Dressing (DuoDERM CGF) DRUG

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

Also known as: hydrocolloid

Hydrocolloid Dressing

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santo Tomas Hospital, Philippines: lead

Study Sites (1)

University of Santo Tomas Hospital

Manila, National Capital Region, 1015, Philippines

Location

Related Publications (17)

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

  BACKGROUND

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  PMID: 3707170 BACKGROUND

• 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.

  PMID: 34993497 BACKGROUND

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  PMID: 17276196 BACKGROUND

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  PMID: 27935418 BACKGROUND

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  PMID: 7894807 BACKGROUND

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  PMID: 8471145 BACKGROUND

• 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.

  PMID: 6395938 BACKGROUND

• 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.

  PMID: 8109684 BACKGROUND

• 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.

  PMID: 8141537 BACKGROUND

• 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.

  PMID: 2616009 BACKGROUND

• 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.

  PMID: 10755338 BACKGROUND

• 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.

  PMID: 19134061 BACKGROUND

• 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.

  PMID: 22713781 BACKGROUND

• 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.

  PMID: 8166487 BACKGROUND

• 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.

  PMID: 19668939 BACKGROUND

• 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/

  PMID: 29262109 BACKGROUND

MeSH Terms

Interventions

Mupirocin; Pharmaceutical Preparations; Anti-Infective Agents; Bandages, Hydrocolloid; Colloids

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Bandages; Equipment and Supplies; Complex Mixtures; Dosage Forms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: January 29, 2024
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)