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CompletedNCT07064161Updated Aug 24, 2025

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

An interventional study of Mupirocin (drug) and Hydrocolloid Dressing (DuoDERM CGF) in Biopsy Wound, sponsored by University of Santo Tomas Hospital, Philippines. Completed at 1 site in Philippines. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by University of Santo Tomas Hospital, Philippines · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jan 2024, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Biopsy Wound

Keywords

  • Biopsy
  • Wound Healing
  • Bandages, Hydrocolloid
  • Dermatology
  • Anti-Bacterial Agents
03

In context

Lead sponsor

University of Santo Tomas Hospital, Philippines is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Hydrocolloid Dressing

    Skin punch biopsy wound treated with hydrocolloid dressing.

    Drug: Hydrocolloid Dressing (DuoDERM CGF)

  • Experimental
    Topical Antibiotic

    Skin punch biopsy wound treated with topical antibiotic.

    Drug: Mupirocin (drug)

Interventions

  • DrugMupirocin (drug)

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

    Also known as: Mupirocin ointment, Antimicrobial, Topical antibacterial

  • DrugHydrocolloid Dressing (DuoDERM CGF)

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

    Also known as: hydrocolloid

06

What researchers measure

Primary outcomes

  1. Absence or Presence of Infection

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

    Time frame: 5 days after punch biopsy.

  2. Clinical Estimate of Reepithelialization

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

    Time frame: 5 days after punch biopsy

  3. Clinical Estimate of Wound Closure

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

    Time frame: 5 days after punch biopsy

  4. Scar Formation

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

    Time frame: 5 days after punch biopsy

  5. Scar Pigmentation

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

    Time frame: 5 days after punch biopsy

  6. Cosmetic Appearance

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

    Time frame: 5 days after punch biopsy

07

Study locations

1 site
  • University of Santo Tomas Hospital
    Manila, National Capital Region 1015, Philippines
08

References and documents

Publications

  • 17. World Health Organization. Antimicrobial resistance. World Health Organization. Published November 21, 2023. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
  • 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. PubMed 3707170 ↗
  • 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. PubMed 34993497 ↗
  • 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. PubMed 17276196 ↗
  • 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. PubMed 27935418 ↗
  • 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. PubMed 7894807 ↗
  • 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. PubMed 8471145 ↗
  • 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. PubMed 6395938 ↗
  • 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. PubMed 8109684 ↗
  • 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. PubMed 8141537 ↗
  • 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. PubMed 2616009 ↗
  • 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. PubMed 10755338 ↗
  • 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. PubMed 19134061 ↗
  • 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. PubMed 22713781 ↗
  • 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. PubMed 8166487 ↗
  • 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. PubMed 19668939 ↗
  • Ramsey ML, Conrad E, Chen RL, Rostami S. Skin Biopsy. 2025 Sep 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470457/ PubMed 29262109 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 25, 2024
  • Informed consent form · Oct 11, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Sharing of the individual participant data was not part of the patient informed consent form.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07064161
Lead sponsor
University of Santo Tomas Hospital, Philippines
Responsible party
Fiona Bianca V. Enriquez (Principal Investigator, University of Santo Tomas Hospital, Philippines) — Principal investigator
First posted
Jul 14, 2025
Start date
Jan 29, 2024
Primary completion
Oct 7, 2024
Completion
Oct 7, 2024
Last update
Aug 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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