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

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

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
        • Contact:
        • 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.

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

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

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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