Partial-thickness Burn, Pain, Second Degree Burn
Conditions
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
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
DEVICEBanana leaf dressing
Sterilized banana leaf as a primary non-adherent burn dressing
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores, as measured using Number Pain Rating Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Total use of opioids and benzodiazepines during wound care sessions | During hospitalization, approximately 14 days | Total morphine-milligram equivalent (MME) and milligrams of benzodiazepines used during each wound care session |
| Time to wound closure | During hospitalization or at follow-up in clinic, approximately within 1 month | Clinical determination of burn wound closure to be made by study team |
| Skin graft rate | During hospitalization, approximately 14 days | Percentage of patients requiring skin grafting |
| Burn wound infection rate | During hospitalization, approximately 14 days | Percentage of patients who develop burn wound infection as defined by the American Burn Association |
| Number of participants with at least one adverse event | End of study (1 year) | Adverse events will only include those that are determined to be related to study device. |
Countries
United States
Contacts
CONTACTCameron Gibson, MD
PRINCIPAL_INVESTIGATORCameron Gibson, MD
University of Colorado, Denver
Outcome results
None listed