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Biopsy WoundNCT07064161

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

A study testing Mupirocin (drug) and Hydrocolloid Dressing (DuoDERM CGF) in people with Biopsy Wound, run by University of Santo Tomas Hospital, Philippines at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Biopsy Wound
What is being tested?
Mupirocin (drug) and Hydrocolloid Dressing (DuoDERM CGF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePhilippines
Study dates
29 Jan 2024to 7 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • University of Santo Tomas Hospital

    Manila, National Capital Region, 1015

Other trials in Philippines

About this study

Official 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

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
Being tested
Mupirocin (drug), Hydrocolloid Dressing (DuoDERM CGF)
Keywords
Biopsy, Wound Healing, Bandages, Hydrocolloid, Dermatology, Anti-Bacterial Agents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mupirocin (drug)Drug

    Also called Mupirocin ointment, Antimicrobial, Topical antibacterial

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

  • Hydrocolloid Dressing (DuoDERM CGF)Drug

    Also called hydrocolloid

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

Study groups in NCT07064161
Study groupRoleWhat they receive
Hydrocolloid DressingExperimentalSkin punch biopsy wound treated with hydrocolloid dressing.
Receives: Drug: Hydrocolloid Dressing (DuoDERM CGF)
Topical AntibioticExperimentalSkin punch biopsy wound treated with topical antibiotic.
Receives: Drug: Mupirocin (drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absence or Presence of Infection

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

    Measured: 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%

    Measured: 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%

    Measured: 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

    Measured: 5 days after punch biopsy

  5. Scar Pigmentation

    Select one of the following for the assessment:

    • Indeterminate or Unhealed
    • Normal
    • Hyperpigmented
    • Hypopigmented

    Measured: 5 days after punch biopsy

  6. Cosmetic Appearance

    Select one of the following for the assessment:

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

    Measured: 5 days after punch biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start29 Jan 2024
  3. Primary completion7 Oct 2024
  4. Study completion7 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07064161
Sponsor's protocol ID
2023-06-047-TR-AP
Status last verified
Aug 2025
First submitted
2 Jul 2025
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing of the individual participant data was not part of the patient informed consent form.

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

Questions about this trial

What is this clinical trial studying?

A study testing Mupirocin (drug) and Hydrocolloid Dressing (DuoDERM CGF) in people with Biopsy Wound, run by University of Santo Tomas Hospital, Philippines at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence or Presence of Infection (time frame: 5 days after punch biopsy.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07064161, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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