Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:15 AM
Study NCT ID:
NCT07453732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient recruitment rate', 'timeFrame': 'End of study (1 year)', 'description': 'Average number of monthly patients recruited for the study'}, {'measure': 'Adherence to study intervention', 'timeFrame': 'End of study (1 year)', 'description': 'Percentage of times patients enrolled in study received treatment with study intervention'}, {'measure': 'Adherence to pain score documentation', 'timeFrame': 'End of study (1 year)', 'description': 'Percentage of properly documented pain scores during wound care sessions'}], 'primaryOutcomes': [{'measure': 'Pain scores, as measured using Number Pain Rating Scale', 'timeFrame': 'Before, during and after each wound care session during hospitalization, approximately 14 days', 'description': 'The Numeric Pain Rating Scale is a unidimensional subjective measure of pain intensity in adults, consisting of a scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst pain imaginable" (or "worst possible pain").'}], 'secondaryOutcomes': [{'measure': 'Total use of opioids and benzodiazepines during wound care sessions', 'timeFrame': 'During hospitalization, approximately 14 days', 'description': 'Total morphine-milligram equivalent (MME) and milligrams of benzodiazepines used during each wound care session'}, {'measure': 'Time to wound closure', 'timeFrame': 'During hospitalization or at follow-up in clinic, approximately within 1 month', 'description': 'Clinical determination of burn wound closure to be made by study team'}, {'measure': 'Skin graft rate', 'timeFrame': 'During hospitalization, approximately 14 days', 'description': 'Percentage of patients requiring skin grafting'}, {'measure': 'Burn wound infection rate', 'timeFrame': 'During hospitalization, approximately 14 days', 'description': 'Percentage of patients who develop burn wound infection as defined by the American Burn Association'}, {'measure': 'Number of participants with at least one adverse event', 'timeFrame': 'End of study (1 year)', 'description': 'Adverse events will only include those that are determined to be related to study device.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Partial-thickness Burn', 'Pain', 'Second Degree Burn']}, 'referencesModule': {'references': [{'pmid': '34765339', 'type': 'BACKGROUND', 'citation': 'Chendake S, Kale T, Manavadaria Y, Motimath AS. Evaluation of Banana Leaves (Musa paradisiaca) as an Alternative Wound Dressing Material Compared to Conventional Petroleum Jelly Gauze Dressing in Contused, Lacerated and Sutured Wounds Over the Head, Neck and Face Region. Cureus. 2021 Oct 6;13(10):e18552. doi: 10.7759/cureus.18552. eCollection 2021 Oct.'}, {'pmid': '23387359', 'type': 'BACKGROUND', 'citation': 'Guenova E, Hoetzenecker W, Kisuze G, Teske A, Heeg P, Voykov B, Hoetzenecker K, Schippert W, Moehrle M. Banana leaves as an alternative wound dressing. Dermatol Surg. 2013 Feb;39(2):290-7. doi: 10.1111/dsu.12067. Epub 2012 Dec 10.'}, {'pmid': '16766833', 'type': 'BACKGROUND', 'citation': 'Srinivas CR, Sundaram VS, Raju BA, Prabhu SK, Thirumurthy M, Bhaskar AC. Achieving asepsis of banana leaves for the management of toxic epidermal necrolysis. Indian J Dermatol Venereol Leprol. 2006 May-Jun;72(3):201-2. doi: 10.4103/0378-6323.25779.'}, {'pmid': '12880731', 'type': 'BACKGROUND', 'citation': 'Gore MA, Akolekar D. Evaluation of banana leaf dressing for partial thickness burn wounds. Burns. 2003 Aug;29(5):487-92. doi: 10.1016/s0305-4179(03)00050-0.'}, {'pmid': '12880730', 'type': 'BACKGROUND', 'citation': 'Gore MA, Akolekar D. Banana leaf dressing for skin graft donor areas. Burns. 2003 Aug;29(5):483-6. doi: 10.1016/s0305-4179(03)00049-4.'}, {'pmid': '7971569', 'type': 'BACKGROUND', 'citation': 'Dharnidharka VR, Kandoth PW. Use of banana leaves in Stevens-Johnson syndrome. Pediatr Dermatol. 1994 Sep;11(3):280-1. doi: 10.1111/j.1525-1470.1994.tb00606.x. No abstract available.'}, {'pmid': '25041616', 'type': 'BACKGROUND', 'citation': 'Hop MJ, Polinder S, van der Vlies CH, Middelkoop E, van Baar ME. Costs of burn care: a systematic review. Wound Repair Regen. 2014 Jul-Aug;22(4):436-50. doi: 10.1111/wrr.12189.'}]}, 'descriptionModule': {'briefSummary': 'This study plans to look at the benefits of banana leaves as a primary burn wound dressing. Study patients will be compared to historical patients', 'detailedDescription': 'Historically, banana leaves have been used as a burn wound dressing in developing countries. Current literature on banana leaf dressings is limited to predominantly pediatric patients and surgical wounds (i.e. skin graft donor sites). The comparison dressing is often other non-standard burn dressings (e.g. boiled potato peel bandage) and these studies are almost exclusively performed in tropical locations where banana plants grow naturally (Africa and Asia). To date, no study on the effectiveness of banana leaf dressings has been done in the United States, nor has there been a focus on their effectiveness in second degree partial thickness burns. Our pilot study aims to establish the feasibility of using banana leaf dressings for second degree partial thickness burn wounds in adult patients, in a geographic location that does not support natural banana agriculture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<10% Total body surface area (TBSA) partial thickness burns\n* Patients age 18 to 99\n* Primary admission (inpatient) to the UCHealth Burn and Frostbite Center\n* Burns \\<48 hours old on admission\n\nExclusion Criteria:\n\n* Patients \\<18 years\n* Patients who are pregnant, incarcerated, or cognitively impaired\n* Burns \\>48 hours old on admission\n* Patients with concurrent traumatic injuries\n* Patients with chemical, electrical, or friction burns\n* Full thickness burns\n* Burns to sensitive areas: face, genitals, hands, feet\n* Burns with evidence of infection on admission\n* Patients with a known allergy to bananas or latex\n* Patients with opioid use disorder or methamphetamine use disorder'}, 'identificationModule': {'nctId': 'NCT07453732', 'briefTitle': 'Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Pilot Study of Banana Leaves as a Primary Wound Dressing for Partial Thickness Burn Wounds', 'orgStudyIdInfo': {'id': '25-2297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Banana leaf dressing', 'description': 'Participants will be treated with banana leaf as a primary non-adherent dressing on their burn wounds', 'interventionNames': ['Device: Banana leaf dressing']}], 'interventions': [{'name': 'Banana leaf dressing', 'type': 'DEVICE', 'description': 'Sterilized banana leaf as a primary non-adherent burn dressing', 'armGroupLabels': ['Banana leaf dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Cameron Gibson, MD', 'role': 'CONTACT', 'email': 'cameron.2.gibson@cuanschutz.edu'}, {'name': 'Cameron Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas Vogler, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arek Wiktor, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Frederick Endorf, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra Halevi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Cameron Gibson, MD', 'role': 'CONTACT', 'email': 'cameron.2.gibson@cuanschutz.edu', 'phone': '720-848-3251'}], 'overallOfficials': [{'name': 'Cameron Gibson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}