Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Colorado, Denver
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
<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
Disqualifiers
Patients <18 years
Patients who are pregnant, incarcerated, or cognitively impaired
Burns >48 hours old on admission
Patients with concurrent traumatic injuries
Trial design
Design model
Single group
Treatments tested in this trial
Banana leaf dressing
DeviceSterilized banana leaf as a primary non-adherent burn dressing
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Banana leaf dressingExperimental treatment 1 intervention
Trial outcomes
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").
Time frame
Before, during and after each wound care session during hospitalization, approximately 14 daysSecondary outcomes
1
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
Time frame
During hospitalization, approximately 14 days2
Time to wound closure
Clinical determination of burn wound closure to be made by study team
Time frame
During hospitalization or at follow-up in clinic, approximately within 1 month3
Skin graft rate
Percentage of patients requiring skin grafting
Time frame
During hospitalization, approximately 14 days4
Burn wound infection rate
Percentage of patients who develop burn wound infection as defined by the American Burn Association
Time frame
During hospitalization, approximately 14 daysOther outcomes
1
Patient recruitment rate
Average number of monthly patients recruited for the study
Time frame
End of study (1 year)2
Adherence to study intervention
Percentage of times patients enrolled in study received treatment with study intervention
Time frame
End of study (1 year)3
Adherence to pain score documentation
Percentage of properly documented pain scores during wound care sessions
Time frame
End of study (1 year)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: