Use of Banana Leaf Dressing on Donor Site Wounds

NCT ID: NCT02083900

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

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.

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.

Conditions

Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Banana Leaf Dressing Group

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

Group Type: EXPERIMENTAL

Banana Leaf Dressing

Intervention Type: 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.

Hydrocolloid Dressing Arm

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

Group Type: ACTIVE_COMPARATOR

Hydrocolloid Dressing (DuoDERM CGF)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

DuoDERM CGF

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the Philippines

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeane Azarcon, MD

Role: PRINCIPAL_INVESTIGATOR

UP Manila

Locations

Philippine General Hospital - University of the Philippines Manila

Manila, National Capital Region, Philippines

Countries

Philippines

Other Identifiers

NIH (TRB) 2005-002

Identifier Type: -

Identifier Source: org_study_id