NCT07453732

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

February 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

February 27, 2026

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain scores, as measured using Number Pain Rating Scale

    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 Outcomes (5)

  • Total use of opioids and benzodiazepines during wound care sessions

    During hospitalization, approximately 14 days

  • Time to wound closure

    During hospitalization or at follow-up in clinic, approximately within 1 month

  • Skin graft rate

    During hospitalization, approximately 14 days

  • Burn wound infection rate

    During hospitalization, approximately 14 days

  • Number of participants with at least one adverse event

    End of study (1 year)

Other Outcomes (3)

  • Patient recruitment rate

    End of study (1 year)

  • Adherence to study intervention

    End of study (1 year)

  • Adherence to pain score documentation

    End of study (1 year)

Study Arms (1)

Banana leaf dressing

EXPERIMENTAL

Participants will be treated with banana leaf as a primary non-adherent dressing on their burn wounds

Device: Banana leaf dressing

Interventions

Sterilized banana leaf as a primary non-adherent burn dressing

Banana leaf dressing

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (7)

  • 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: 34765339BACKGROUND
  • 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: 23387359BACKGROUND
  • 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: 16766833BACKGROUND
  • 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: 12880731BACKGROUND
  • 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: 12880730BACKGROUND
  • 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: 7971569BACKGROUND
  • 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.

    PMID: 25041616BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cameron Gibson, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations