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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202208841557072 Date of Approval: 22/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Aloe Vera Fresh Leaf compared with 1% Silver Sulfadiazine cream in the healing of second-degree burns in Children
Official scientific title Effectiveness of Aloe Vera Fresh Leaf compared with 1% Silver Sulfadiazine cream in the healing of second-degree burns in Children: A comparative Study
Brief summary describing the background and objectives of the trial Globally, burns are a public health problem accounting for an estimated 8 million in morbidity, and over 180 000 moralities annually. In The Gambia, burns are among the leading cause of injuries among children and put a significant burden on inpatient services. The care and management of burns can be very costly, both in terms of direct and indirect costs to families and society. One of the recommended topical antimicrobial used in the management of burns is 1% silver sulfadiazine (SSD) cream. However, long-term use may lead to microbial resistance and hepatic or renal toxicity. The use of Aloe Vera products for the treatment of burns has previously shown promising results and may be used as an alternative to 1% Silver Sulfadiazine (SSD). Therefore, we aim to investigate the effectiveness of Aloe Vera Fresh Leaf (Aloe Barbadensis Miller) compared to 1% SSD in the treatment of second-degree burns in children. Specific objectives: 1) To compare the average time taken from the start of treatment to complete epithelialization between those treated with AVFL and those with 1% SSD. 2) To identify factors associated with burn injury outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/12/2022
Actual trial start date
Anticipated date of last follow up 04/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dressing the burn with Aloe Vera Fresh Leaf Two daily and less frequent depending on wound progression Until complete epithelialization Before dressing, the wound will be washed with 1% povidone scrub and normal saline. The AVFL will be washed and peeled partly, leaving one side intact, to expose the fresh gel-like substance, which will first be spread gently over the burnt surface. A one-layer piece of gauze soaked in paraffin liquid will then be placed over the entire wound and generously over its wound edges and finally, the peeled side of the fresh leaves will be placed over the burn. Using an elastic bandage (sterile), the entire area will be fixated. 26
Control Group Dressing with one percent Silver Sulfadiazine Daily, with less frequency depending on wound progression Until complete epithelialization Before dressing, the wound will be washed with 1% povidone scrub and normal saline, then 1% SSD will be gently applied over the entire wound. 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All burns patients 15 years and below Have a second degree burn Burns with <25% total surface area (TSA) Children with birth defects Those with corrosive, electrical, and chemical burns History of diabetes, epilepsy, or kidney disease Altered mental status that hinder communication for older children Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Year(s) 15 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 02/05/2022 Edward Francis Small Teaching Ethics committee
Ethics Committee Address
Street address City Postal code Country
Independence Drive Banjul 000 Gambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to complete epithelialization At complete epithelialization
Secondary Outcome Incidence of infection At admission and every 7th day
Secondary Outcome Pain score Post dressing at 30 minutes interval for 2 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Edward Francis Small Teaching Hospital Independence Drive Banjul Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
City Link Ostend Banjul Project for Sustainable development independence drive Banjul Gambia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Edward Francis Small Teaching Hospital independence Drive Banjul Gambia Hospital
COLLABORATORS
Name Street address City Postal code Country
Haddy Tunkara Bah Independence Drive Banjul Gambia
Phebian Ina Grante Independence Drive Banjul Gambia
Charles A. P. Roberts Independence Drive Banjul Gambia
Jainaba SeySawo Independence Drive Banjul Gambia
Thomas Senghore Independence Drive Banjul Gambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jainaba Sey Sawo jsey@utg.edu.gm +2203650105 independence Drive
City Postal code Country Position/Affiliation
Banjul Gambia Senior Lecturer and Head of Department Nursing and Reproductive Health University of the Gambia
Role Name Email Phone Street address
Scientific Enquiries Thomas Senghore tsenghore@utg.edu.gm +2203739629 Independence Drive
City Postal code Country Position/Affiliation
Banjul Gambia Senior Lecturer School of Nursing and Reproductive Health University of The Gambia
Role Name Email Phone Street address
Public Enquiries Phebian Ina Grante inaspecial@gmail.com +2207387777 independence Drive
City Postal code Country Position/Affiliation
Banjul Gambia Principal Health Researcher Directorate of Health Research Ministry of Health The Gambia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual patient data collected during the trial, after deidentification, the results reported including text, tables, figures, and appendix will be shared Clinical Study Report,Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 3 years after article publication Researcher who have a sound study proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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