Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202002762137087 Date of Registration: 11/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparison between banana leaf dressing and Vaseline gauze dressing for split-thickness skin graft donor sites at a Ugandan hospital
Official scientific title A comparison between banana leaf dressing and Vaseline gauze dressing for split-thickness skin graft donor sites at a Ugandan hospital
Brief summary describing the background and objectives of the trial Background Use of Split thickness skin grafts (SSG) is common in plastic and reconstructive surgery for coverage of a wide range of defects.The pain experienced at SSG donor wounds is significant, however, it reduces as the wounds heal. The healing of the donor wound depends on rapid re-epithelialisation under a moist dressing. The ideal dressing for the SSG donor site should be moist, allow gaseous exchange and remove exudate. It should also be sterile, resistant to infection, comfortable for the patient, easily applied and removed from the wound and cost effective. Such a dressing is yet to be developed. Vaseline gauze dressing (VGD) or petrolatum impregnated gauze is the commonest used dressing however, it is not completely non-adherent and is associated with pain on removal. Banana leaf dressing (BLD) has been used as a dressing for surgical wounds in India for 3 decades now. It is non adherent, pain-free dressing. It offers a large smooth surface, is cheap and readily available in Uganda throughout the year. It has also been found to be a good alternative dressing for surgical wounds in Uganda. The general objective of this study was to assess the effectiveness of BLD as a dressing for SSG donor sites in comparison to VGD. Specific Objectives: I. To compare the pain scores between donor sites dressed with BLD and those dressed with Vaseline gauze on post-operative days 3, 5, 7 & 9 and on dressing change. II. To compare the percentage epithelialisation achieved on donor site wounds dressed with BLD with those dressed with VGD on post-operative day 10. III. To identify and compare the microbial characteristics of SSG donor sites on post-operative day 10 on wounds dressed with BLD and the dressed with VGD. IV. To compare the cost and ease of use of VGD with that of BLD for SSG donor site wounds within the first 10 postoperative days.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 27/06/2017
Actual trial start date 27/06/2017
Anticipated date of last follow up 27/06/2018
Actual Last follow-up date 13/04/2018
Anticipated target sample size (number of participants) 95
Actual target sample size (number of participants) 86
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Banana Leaf Dressing 10 days The participants had their Skin graft donor sites dressed with Banana Leaf Dressing for 10 days postoperatively. 45
Control Group Vaseline Gauze dressing 10 days Participants had their skin graft donor site wounds dressed with Vaseline gauze dressing for 10 days postoperatively 41 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All patients undergoing harvest of SSG from the thigh. 2. Patients 10 years of age and above. 1. Patients with comorbidities which are known to impede normal wound healing. 2. Patients with a known history of substance abuse or long term pain medication. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/06/2017 Mbarara University Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mbarara Mbarara 1410 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post operative pain On post operative days 3,5,7 and 9
Primary Outcome pain on dressing change Day 10 post operative
Primary Outcome Percentage epithelialisation of donor site wound Day 10 post operative
Primary Outcome Microbial characteristics of donor site wound Day 10 postoperative
Secondary Outcome Ease of application of dressings to donor site wound during wound dressing Intraoperatively
Secondary Outcome Ease of removal of dressings from donor site wound On day 10 postoperative
Secondary Outcome Cost of dressings on Day 10 post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CoRSU Rehabilitation Hospital 125, Kisubi, Entebbe Road Kisubi Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Christian Blind Mission Germany Stubenwald-Allee 5 Bensheim 64625 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Christian Blind Mission Stubenwald-Allee 5, 64625 Bensheim, Germany Bensheim 64625 Germany Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr George William Galiwango 125 Kisubi Entebbe Uganda
Andrew Michael Hodges 125 Kisubi Entebbe Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naomi Leah Kekisa naomileahk@gmail.com +256776809494 125 Kisubi
City Postal code Country Position/Affiliation
Entebbe Uganda Plastic surgeon
Role Name Email Phone Street address
Public Enquiries Naomi Leah Kekisa naomileahk@gmail.com +256766809494 125 Kisubi
City Postal code Country Position/Affiliation
Entebbe Uganda Plastic Surgeon
Role Name Email Phone Street address
Scientific Enquiries George William Galiwango georgegaliwango@gmail.com +256772383677 125 Kisubi
City Postal code Country Position/Affiliation
Entebbe Uganda Consultant Plastic surgeon
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol immediately following publication with no end date Investigators whose proposed use of the data has been approved by an independent review committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Link to be added No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information