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Use of Banana Leaf Dressing on Donor Site Wounds

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ClinicalTrials.gov Identifier: NCT02083900
Recruitment Status : Unknown
Verified March 2014 by University of the Philippines.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
University of the Philippines

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.

Condition or disease Intervention/treatment Phase
Split Thickness Skin Graft Donor Site Wounds. Device: Banana Leaf Dressing Drug: Hydrocolloid Dressing (DuoDERM CGF) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Use of Banana Leaf Dressing on Donor Site Wounds: A Prospective Randomized Control Study
Study Start Date : October 2006
Actual Primary Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Banana Leaf Dressing Group
The Banana Leaf Dressing site will receive a single layer of banana leaf dressing
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.

Active Comparator: Hydrocolloid Dressing Arm
The donor under Hydrocolloid dressing was covered with hydrocolloid (DuoDERM CGF).
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.




Primary Outcome Measures :
  1. Healing Assessment and Efficacy of the dressing [ Time Frame: 8th post harvest day ]

    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.



Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: taken from 24hours, on the 48th and 72 hour post skin harvest ]
    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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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083900


Locations
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Philippines
Philippine General Hospital - University of the Philippines Manila
Manila, Metro Manila, Philippines, 1000
Sponsors and Collaborators
University of the Philippines

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Responsible Party: University of the Philippines
ClinicalTrials.gov Identifier: NCT02083900     History of Changes
Other Study ID Numbers: NIH (TRB) 2005-002
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
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Wounds and Injuries