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

Not Applicable

Completed

• Conditions: Biopsy Wound
• Interventions: Drug: Hydrocolloid Dressing (DuoDERM CGF); Drug: Mupirocin (drug)

• Registration Number: NCT07064161
• Lead Sponsor: University of Santo Tomas Hospital, Philippines

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Primary Completion: 2024-10-07
• Study Completion: 2024-10-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Study First Posted: 2025-07-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-18
• Last Update Posted: 2025-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocolloid Dressing	Hydrocolloid Dressing (DuoDERM CGF)	Skin punch biopsy wound treated with hydrocolloid dressing.
Topical Antibiotic	Mupirocin (drug)	Skin punch biopsy wound treated with topical antibiotic.

Primary Outcome Measures

Name	Time	Method
Absence or Presence of Infection	5 days after punch biopsy.	Absent - millimeters of surrounding erythema or equivocal findings Present - as inferred by indurated erythema or purulent discharge
Clinical Estimate of Reepithelialization	5 days after punch biopsy	Rated on a scale of: * 0% to 25%; * 26% to 50%; * 51% to 75%; * 76% to 100%
Clinical Estimate of Wound Closure	5 days after punch biopsy	Rated on a scale of: * 0% to 25%; * 26% to 50%; * 51% to 75%; * 76% to 100%
Scar Formation	5 days after punch biopsy	Select one of the following for the assessment: * Unhealed; * Depressed or Atrophied; * Normal fine-line scar; * Hypertrophied scar or Keloid
Scar Pigmentation	5 days after punch biopsy	Select one of the following for the assessment: * Indeterminate or Unhealed; * Normal; * Hyperpigmented; * Hypopigmented
Cosmetic Appearance	5 days after punch biopsy	Select one of the following for the assessment: * Indeterminate or Unhealed; * Poor; * Fair; * Good; * Excellent

Trial Locations

Locations (1)

University of Santo Tomas Hospital; 🇵🇭 Manila, National Capital Region, Philippines