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Completed

NCT Number: NCT07064161

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

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.

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Key information

Conditions

Biopsy Wound

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Santo Tomas Hospital

Manila, National Capital Region, 1015, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mupirocin (drug)

Drug

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

Other names: Mupirocin ointment, Antimicrobial, Topical antibacterial

Hydrocolloid Dressing (DuoDERM CGF)

Drug

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

Other names: hydrocolloid

Primary outcomes

  1. Absence or Presence of Infection

    Time frame: 5 days after punch biopsy.

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

  2. Clinical Estimate of Reepithelialization

    Time frame: 5 days after punch biopsy

    Rated on a scale of:

    • 0% to 25%
    • 26% to 50%
    • 51% to 75%
    • 76% to 100%

  3. Clinical Estimate of Wound Closure

    Time frame: 5 days after punch biopsy

    Rated on a scale of:

    • 0% to 25%
    • 26% to 50%
    • 51% to 75%
    • 76% to 100%

  4. Scar Formation

    Time frame: 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

  5. Scar Pigmentation

    Time frame: 5 days after punch biopsy

    Select one of the following for the assessment:

    • Indeterminate or Unhealed
    • Normal
    • Hyperpigmented
    • Hypopigmented

  6. Cosmetic Appearance

    Time frame: 5 days after punch biopsy

    Select one of the following for the assessment:

    • Indeterminate or Unhealed
    • Poor
    • Fair
    • Good
    • Excellent

Sponsors and collaborators

Lead sponsor

University of Santo Tomas Hospital, Philippines

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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