- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02083900
Use of Banana Leaf Dressing on Donor Site Wounds
Use of Banana Leaf Dressing on Donor Site Wounds: A Prospective Randomized Control Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.
Adult patients with no uncontrolled medical condition admitted at Philippine General Hospital Burn Center requiring split thickness skin graft for their burn. this is to compare the efficacy and safety of Banana Leaf Dressing with Hydrocolloid dressing among patients undergoing split thickness skin graft for their burn.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Metro Manila
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Manila, Metro Manila, Philippines, 1000
- Philippine General Hospital - University of the Philippines Manila
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient undergoing harvesting of skin graft one or both thigh
- Surgery under general anesthesia
- Given informed consent and has accomplished a written inform consent
Exclusion Criteria:
- Patient with uncontrolled medical condition such as diabetes or hypertension
- Pregnant females
- Patients in whom legs or back was used as donor site
- Surgery under regional anesthesia
- Refused inclusion into the study
- Patients who had previous skin harvesting on the area of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Banana Leaf Dressing Group
The Banana Leaf Dressing site will receive a single layer of banana leaf dressing
|
Banana leaf dressing will be prepared by cutting the mid rib of the leaf cutting the leaf into standard size of 12 x 12 inches to facilitate packing.
The leaves are rolled and packed in polypropelene bags and subject to gamma irradiation or packed in paper bags for autoclaving.
The Banana Leaf Dressing site will receive a single layer of banana leaf without any topical antibiotic applied to the wound followed by a layer of dry gauze for absorption of exudates.
The dressing is secured with cling wrap to maintain an occlusive environment.
This is then covered by rolled gauze and elastic bandage.
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Active Comparator: Hydrocolloid Dressing Arm
The donor under Hydrocolloid dressing was covered with hydrocolloid (DuoDERM CGF).
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The donor under HCD was covered with hydrocolloid (DuoDERM CGF).
The hydrocolloid dressing was cut to the size of the donor site with an overlap of at least 2 centimeter around the wound edge.
After pulling off the adhesive backing, care was taken to ensure that the adhesive was in direct contact with the raw surface.
This was likewise covered with a top dressing of gauze for absorption of exudates and an elastic bandage to secure dressing.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healing Assessment and Efficacy of the dressing
Time Frame: 8th post harvest day
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After 8th post harvest day The degree of healing will be assessed. Direct inspection of the wound will be made by experienced burn surgeon. The degree of re-epithelialization will be graded as follow: No Re-epithelialization = zero (0); Less than 50% = one (1); More than 50% but not complete = Two (2), and Complete (90% or more) = Three (3). Complete Re-epithelialization is synonymous to healing on which 90% or more of the wound surface is re-epithelialized. |
8th post harvest day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores
Time Frame: taken from 24hours, on the 48th and 72 hour post skin harvest
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This pain score shall be determined on each patient using a visual analog pain intensity scale the score is as follows: 0-1=no pain; 2-3= Mild pain; 4-5=Moderate pain; 7-8= Severe pain; 9-10=Worst possible.
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taken from 24hours, on the 48th and 72 hour post skin harvest
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeane Azarcon, MD, UP Manila
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NIH (TRB) 2005-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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