Efficacy of Hydrocolloid Dressing vs. Topical Antibiotic on Wound Healing of Post-Punch Biopsy Wounds
NCT ID: NCT07064161
Last Updated: 2025-08-24
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-01-29
2024-10-07
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hydrocolloid Dressing
Skin punch biopsy wound treated with hydrocolloid dressing.
Hydrocolloid Dressing (DuoDERM CGF)
Wounds were dressed with a 1-inch size Duoderm Control Gel Formula hydrocolloid dressing
Topical Antibiotic
Skin punch biopsy wound treated with topical antibiotic.
Mupirocin (drug)
Wounds were dressed with gauze impregnated with mupirocin ointment covered by a transparent dressing (Tegaderm)
Interventions
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Mupirocin (drug)
Wounds were dressed with gauze impregnated with mupirocin ointment covered by a transparent dressing (Tegaderm)
Hydrocolloid Dressing (DuoDERM CGF)
Wounds were dressed with a 1-inch size Duoderm Control Gel Formula hydrocolloid dressing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
64 Years
ALL
No
Sponsors
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University of Santo Tomas Hospital, Philippines
OTHER
Responsible Party
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Fiona Bianca V. Enriquez
Principal Investigator
Locations
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University of Santo Tomas Hospital
Manila, National Capital Region, Philippines
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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/
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2023-06-047-TR-AP
Identifier Type: -
Identifier Source: org_study_id
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