Use of Banana Leaf Dressing on Donor Site Wounds

Burn Clinical Trial

Official title:

Use of Banana Leaf Dressing on Donor Site Wounds: A Prospective Randomized Control Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02083900
• Other study ID #: NIH (TRB) 2005-002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2006

Study information

• Verified date: April 2020
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn

Intervention

Device:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
Philippines	Philippine General Hospital - University of the Philippines Manila	Manila	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
University of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Assessment and Efficacy of the dressing	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
Secondary	Pain Scores	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.	taken from 24hours, on the 48th and 72 hour post skin harvest