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Not yet recruiting NCT07453732

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

No phase Interventional Partial-thickness Burn Pain Second Degree Burn

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Banana leaf dressing.
Who it may be relevant to
Registry conditions: Partial-thickness Burn, Pain, Second Degree Burn. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Device Banana leaf dressing
    Sterilized banana leaf as a primary non-adherent burn dressing

Primary outcome measures

  • Pain scores, as measured using Number Pain Rating Scale [Time frame: Before, during and after each wound care session during hospitalization, approximately 14 days]
Secondary outcome measures (5)
  • Total use of opioids and benzodiazepines during wound care sessions [Time frame: During hospitalization, approximately 14 days]
  • Time to wound closure [Time frame: During hospitalization or at follow-up in clinic, approximately within 1 month]
  • Skin graft rate [Time frame: During hospitalization, approximately 14 days]
  • Burn wound infection rate [Time frame: During hospitalization, approximately 14 days]
  • Number of participants with at least one adverse event [Time frame: End of study (1 year)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Hospital — Aurora

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. PMID 34765339
  • 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 23387359
  • 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 16766833
  • 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 12880731
  • 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 12880730
  • 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 7971569
  • 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 25041616

Identifiers

NCT: NCT07453732 · 25-2297

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗