Partial-thickness BurnNCT07453732
Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.
A study testing Banana leaf dressing in people with Partial-thickness Burn and Pain, run by University of Colorado, Denver at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Partial-thickness Burn, Pain, Second Degree Burn
- What is being tested?
- Banana leaf dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
Cameron Gibson, MD, cameron.2.gibson@cuanschutz.edu
Cameron Gibson, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Partial-thickness Burn, Pain, Second Degree Burn
- Being tested
- Banana leaf dressing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banana leaf dressingDevice
Sterilized banana leaf as a primary non-adherent burn dressing
| Study group | Role | What they receive |
|---|---|---|
| Banana leaf dressing | Experimental | Participants will be treated with banana leaf as a primary non-adherent dressing on their burn wounds Receives: Device: Banana leaf dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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
Total morphine-milligram equivalent (MME) and milligrams of benzodiazepines used during each wound care session
Measured: During hospitalization, approximately 14 days
Time to wound closure
Clinical determination of burn wound closure to be made by study team
Measured: During hospitalization or at follow-up in clinic, approximately within 1 month
Skin graft rate
Percentage of patients requiring skin grafting
Measured: During hospitalization, approximately 14 days
Burn wound infection rate
Percentage of patients who develop burn wound infection as defined by the American Burn Association
Measured: During hospitalization, approximately 14 days
Number of participants with at least one adverse event
Adverse events will only include those that are determined to be related to study device.
Measured: End of study (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Partial-thickness BurnStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cameron Gibson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453732
- Sponsor's protocol ID
- 25-2297
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34765339Guenova 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.
PubMed 23387359Srinivas 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.
PubMed 16766833Gore 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.
PubMed 12880731Gore 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.
PubMed 12880730Dharnidharka 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.
PubMed 7971569Hop 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.
PubMed 25041616
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Banana Leaves as a Primary Wound Dressing for Partial Thickness Burn Wounds
- ClinicalTrials.gov ID
- NCT07453732
- Acronym / sponsor ID
- 25-2297
- Conditions
- Partial-thickness Burn, Pain, Second Degree Burn
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Banana leaf dressing | Experimental | Device: Banana leaf dressingParticipants will be treated with banana leaf as a primary non-adherent dressing on their burn wounds |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- <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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Banana leaf dressingSterilized banana leaf as a primary non-adherent burn dressing | Device | Banana leaf dressing |
Primary outcome
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").
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 34765339Chendake 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.
- Background: PubMed 23387359Guenova 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.
- Background: PubMed 16766833Srinivas 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.
- Background: PubMed 12880731Gore 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.
- Background: PubMed 12880730Gore 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.
- Background: PubMed 7971569Dharnidharka 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.
- Background: PubMed 25041616Hop 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cameron Gibson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Banana leaf dressing in people with Partial-thickness Burn and Pain, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cameron Gibson, MD (720-848-3251, cameron.2.gibson@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores, as measured using Number Pain Rating Scale (time frame: Before, during and after each wound care session during hospitalization, approximately 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07453732, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.