Overview

This trial is active, not recruiting.

Condition split thickness skin graft donor site wounds.
Treatments banana leaf dressing, hydrocolloid dressing (duoderm cgf)
Phase phase 2
Sponsor University of the Philippines
Start date October 2006
End date September 2007
Trial size 10 participants
Trial identifier NCT02083900, NIH (TRB) 2005-002

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
The Banana Leaf Dressing site will receive a single layer of banana leaf dressing
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.
(Active Comparator)
The donor under Hydrocolloid dressing was covered with hydrocolloid (DuoDERM CGF).
hydrocolloid dressing (duoderm cgf)
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.

Primary Outcomes

Measure
Healing Assessment and Efficacy of the dressing
time frame: 8th post harvest day

Secondary Outcomes

Measure
Pain Scores
time frame: taken from 24hours, on the 48th and 72 hour post skin harvest

Eligibility Criteria

Male or female participants from 20 years up to 40 years old.

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

Additional Information

Official title Use of Banana Leaf Dressing on Donor Site Wounds: A Prospective Randomized Control Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by University of the Philippines.