Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-31 @ 6:16 AM
Study NCT ID:
NCT07064161
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Hydrocolloid Dressing vs. Topical Antibiotic on Wound Healing of Post-Punch Biopsy Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016712', 'term': 'Mupirocin'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D047070', 'term': 'Bandages, Hydrocolloid'}, {'id': 'D003102', 'term': 'Colloids'}], 'ancestors': [{'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-25', 'size': 376095, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-18T04:04', 'hasProtocol': True}, {'date': '2023-10-11', 'size': 97236, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-29T11:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence or Presence of Infection', 'timeFrame': '5 days after punch biopsy.', 'description': 'Absent - millimeters of surrounding erythema or equivocal findings Present - as inferred by indurated erythema or purulent discharge'}, {'measure': 'Clinical Estimate of Reepithelialization', 'timeFrame': '5 days after punch biopsy', 'description': 'Rated on a scale of:\n\n* 0% to 25%\n* 26% to 50%\n* 51% to 75%\n* 76% to 100%'}, {'measure': 'Clinical Estimate of Wound Closure', 'timeFrame': '5 days after punch biopsy', 'description': 'Rated on a scale of:\n\n* 0% to 25%\n* 26% to 50%\n* 51% to 75%\n* 76% to 100%'}, {'measure': 'Scar Formation', 'timeFrame': '5 days after punch biopsy', 'description': 'Select one of the following for the assessment:\n\n* Unhealed\n* Depressed or Atrophied\n* Normal fine-line scar\n* Hypertrophied scar or Keloid'}, {'measure': 'Scar Pigmentation', 'timeFrame': '5 days after punch biopsy', 'description': 'Select one of the following for the assessment:\n\n* Indeterminate or Unhealed\n* Normal\n* Hyperpigmented\n* Hypopigmented'}, {'measure': 'Cosmetic Appearance', 'timeFrame': '5 days after punch biopsy', 'description': 'Select one of the following for the assessment:\n\n* Indeterminate or Unhealed\n* Poor\n* Fair\n* Good\n* Excellent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biopsy', 'Wound Healing', 'Bandages, Hydrocolloid', 'Dermatology', 'Anti-Bacterial Agents'], 'conditions': ['Biopsy Wound']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '17. World Health Organization. Antimicrobial resistance. World Health Organization. Published November 21, 2023. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance'}, {'pmid': '3707170', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '34993497', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17276196', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27935418', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7894807', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8471145', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '6395938', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8109684', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8141537', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2616009', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10755338', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19134061', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22713781', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8166487', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19668939', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29262109', 'type': 'BACKGROUND', 'citation': '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/'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe primary outcome measure is the proportion of patients who achieved better overall healing when treated with hydrocolloid dressing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients 18 to 64 years old with clean cutaneous lesions who underwent skin punch biopsy using 3-mm disposable biopsy puncher.\n\nExclusion Criteria:\n\n* Patients with infected wounds.\n* 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.\n* Patients known to have hypersensitivity to topical antibiotics.'}, 'identificationModule': {'nctId': 'NCT07064161', 'briefTitle': 'Efficacy of Hydrocolloid Dressing vs. Topical Antibiotic on Wound Healing of Post-Punch Biopsy Wounds', 'organization': {'class': 'OTHER', 'fullName': 'University of Santo Tomas Hospital, Philippines'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2023-06-047-TR-AP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrocolloid Dressing', 'description': 'Skin punch biopsy wound treated with hydrocolloid dressing.', 'interventionNames': ['Drug: Hydrocolloid Dressing (DuoDERM CGF)']}, {'type': 'EXPERIMENTAL', 'label': 'Topical Antibiotic', 'description': 'Skin punch biopsy wound treated with topical antibiotic.', 'interventionNames': ['Drug: Mupirocin (drug)']}], 'interventions': [{'name': 'Mupirocin (drug)', 'type': 'DRUG', 'otherNames': ['Mupirocin ointment', 'Antimicrobial', 'Topical antibacterial'], 'description': 'Wounds were dressed with gauze impregnated with mupirocin ointment covered by a transparent dressing (Tegaderm)', 'armGroupLabels': ['Topical Antibiotic']}, {'name': 'Hydrocolloid Dressing (DuoDERM CGF)', 'type': 'DRUG', 'otherNames': ['hydrocolloid'], 'description': 'Wounds were dressed with a 1-inch size Duoderm Control Gel Formula hydrocolloid dressing', 'armGroupLabels': ['Hydrocolloid Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1015', 'city': 'Manila', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'University of Santo Tomas Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing of the individual participant data was not part of the patient informed consent form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Santo Tomas Hospital, Philippines', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fiona Bianca V. Enriquez', 'investigatorAffiliation': 'University of Santo Tomas Hospital, Philippines'}}}}