Use of Banana Leaf Dressing on Donor Site Wounds

NCT02083900 | Unknown Phase 2 DMC

• 1 other identifier: NIH (TRB) 2005-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Scores

  taken from 24hours, on the 48th and 72 hour post skin harvest

Study Arms (2)

Banana Leaf Dressing Group

EXPERIMENTAL

The Banana Leaf Dressing site will receive a single layer of banana leaf dressing

Device: Banana Leaf Dressing

Hydrocolloid Dressing Arm

ACTIVE COMPARATOR

The donor under Hydrocolloid dressing was covered with hydrocolloid (DuoDERM CGF).

Drug: Hydrocolloid Dressing (DuoDERM CGF)

Interventions

Banana Leaf Dressing DEVICE

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.

Banana Leaf Dressing Group

Hydrocolloid Dressing (DuoDERM CGF) DRUG

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.

Also known as: DuoDERM CGF

Hydrocolloid Dressing Arm

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient undergoing harvesting of skin graft one or both thigh
• Surgery under general anesthesia
• Given informed consent and has accomplished a written inform consent

You may not qualify if:

• 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
• Patients who had previous skin harvesting on the area of the study

Sponsors & Collaborators

• University of the Philippines: lead

Study Sites (1)

Philippine General Hospital - University of the Philippines Manila

Manila, National Capital Region, 1000, Philippines

Location

MeSH Terms

Conditions

Burns

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Jeane Azarcon, MD

  UP Manila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 11, 2014
• Study Start: October 1, 2006
• Primary Completion: September 1, 2007
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

PH (1)