- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07453732
Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.
March 19, 2026 updated by: University of Colorado, Denver
Pilot Study of Banana Leaves as a Primary Wound Dressing for Partial Thickness Burn Wounds
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cameron Gibson, MD
- Phone Number: 720-848-3251
- Email: cameron.2.gibson@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
Contact:
- Cameron Gibson, MD
- Email: cameron.2.gibson@cuanschutz.edu
-
Principal Investigator:
- Cameron Gibson, MD
-
Sub-Investigator:
- Thomas Vogler, MD
-
Sub-Investigator:
- Arek Wiktor, MD
-
Sub-Investigator:
- Frederick Endorf, MD
-
Sub-Investigator:
- Alexandra Halevi, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- <10% Total body surface area (TBSA) partial thickness burns
- Patients age 18 to 99
- Primary admission (inpatient) to the UCHealth Burn and Frostbite Center
- Burns <48 hours old on admission
Exclusion Criteria:
- Patients <18 years
- Patients who are pregnant, incarcerated, or cognitively impaired
- Burns >48 hours old on admission
- Patients with concurrent traumatic injuries
- Patients with chemical, electrical, or friction burns
- Full thickness burns
- Burns to sensitive areas: face, genitals, hands, feet
- Burns with evidence of infection on admission
- Patients with a known allergy to bananas or latex
- Patients with opioid use disorder or methamphetamine use disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Banana leaf dressing
Participants will be treated with banana leaf as a primary non-adherent dressing on their burn wounds
|
Sterilized banana leaf as a primary non-adherent burn dressing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores, as measured using Number Pain Rating Scale
Time Frame: Before, during and after each wound care session during hospitalization, approximately 14 days
|
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").
|
Before, during and after each wound care session during hospitalization, approximately 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total use of opioids and benzodiazepines during wound care sessions
Time Frame: During hospitalization, approximately 14 days
|
Total morphine-milligram equivalent (MME) and milligrams of benzodiazepines used during each wound care session
|
During hospitalization, approximately 14 days
|
|
Time to wound closure
Time Frame: During hospitalization or at follow-up in clinic, approximately within 1 month
|
Clinical determination of burn wound closure to be made by study team
|
During hospitalization or at follow-up in clinic, approximately within 1 month
|
|
Skin graft rate
Time Frame: During hospitalization, approximately 14 days
|
Percentage of patients requiring skin grafting
|
During hospitalization, approximately 14 days
|
|
Burn wound infection rate
Time Frame: During hospitalization, approximately 14 days
|
Percentage of patients who develop burn wound infection as defined by the American Burn Association
|
During hospitalization, approximately 14 days
|
|
Number of participants with at least one adverse event
Time Frame: End of study (1 year)
|
Adverse events will only include those that are determined to be related to study device.
|
End of study (1 year)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient recruitment rate
Time Frame: End of study (1 year)
|
Average number of monthly patients recruited for the study
|
End of study (1 year)
|
|
Adherence to study intervention
Time Frame: End of study (1 year)
|
Percentage of times patients enrolled in study received treatment with study intervention
|
End of study (1 year)
|
|
Adherence to pain score documentation
Time Frame: End of study (1 year)
|
Percentage of properly documented pain scores during wound care sessions
|
End of study (1 year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cameron Gibson, MD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Study Registration Dates
First Submitted
February 27, 2026
First Submitted That Met QC Criteria
February 27, 2026
First Posted (Actual)
March 6, 2026
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 19, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-2297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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