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NCT Number: NCT07453732

Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location contact

Alexandra Halevi, MD

SUB_INVESTIGATOR

Arek Wiktor, MD

SUB_INVESTIGATOR

Cameron Gibson, MD

CONTACT

[email protected]

Cameron Gibson, MD

PRINCIPAL_INVESTIGATOR

Frederick Endorf, MD

SUB_INVESTIGATOR

Thomas Vogler, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Banana leaf dressing

Device

Sterilized banana leaf as a primary non-adherent burn dressing

Primary outcomes

  1. 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").

Secondary outcomes

  1. 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

  2. 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

  3. Skin graft rate

    Time frame: During hospitalization, approximately 14 days

    Percentage of patients requiring skin grafting

  4. 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

  5. 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.

Other outcomes

  1. Patient recruitment rate

    Time frame: End of study (1 year)

    Average number of monthly patients recruited for the study

  2. Adherence to study intervention

    Time frame: End of study (1 year)

    Percentage of times patients enrolled in study received treatment with study intervention

  3. Adherence to pain score documentation

    Time frame: End of study (1 year)

    Percentage of properly documented pain scores during wound care sessions

Study contacts

Contact information is provided by the study sponsor or research team.

Cameron Gibson, MD

CONTACT

[email protected]

720-848-3251

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Pilot Study of Banana Leaves as a Primary Wound Dressing for Partial Thickness Burn Wounds

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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