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.: PACTR202309540218056 Date of Approval: 28/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical Outcomes of Burns after Health Worker Training on Essential Burn Life Support a Comparative Study at Two Main Treatment Hospitals in Lusaka, Zambia.
Official scientific title Clinical Outcomes of Burns after Health Worker Training on Essential Burn Life Support a Comparative Study at Two Main Treatment Hospitals in Lusaka, Zambia.
Brief summary describing the background and objectives of the trial Front line health workers in LMIC are often faced with challenges in triaging and managing burns for instance, assessing the size of the burn wound surface, deciding whether fluid resuscitation is required or surgery or transfer to specialized or more capable facilities based on initial assessment. Improper management could increase patient morbidity and mortality. One way to ease the burden on health workers is to create training opportunities in burns care. The aim of this study is to assess the clinical outcome of burn patients after health worker training on Essential Burn Life Suppport (EBLS). Primary Outcomes in Patients: Mortality Burn wound infection Length of hospital stay Health Worker Training Our study will aim to train health workers who provide care regularly to burns patients and will include- nurses in the general surgical wards, intern doctors and registrars in general surgery, physiotherapists, nutritionists, as well as critical care staff in intensive care units that admit burns patients (Nurses and Doctors). The course content will be derived from the “Essential Burns Care Training Manual” by the International Network for Training, Education and Research in Burns (Interburns). Breakout groups will help us achieve two things, firstly, some groups will be composed of same speciality members to ensure in depth discussion of management i.e. surgical registrars could discuss in depth about indications for skin grafting and physiotherapist about the different positioning and splinting options for burns. Secondly the mixed discipline groups will encourage multidisciplinary approach in burns care. Course component Details Trainers- Surgeons,Registrars, nurses, physiotherapist, nutritionist from the study sites Location- Study sites Content - Essential burns Care- Interburns training manual Mode of teaching- Lecture, case series, role play, group discussion Evaluation- Questionnaire
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 03/07/2023
Actual trial start date 24/07/2023
Anticipated date of last follow up 29/02/2024
Actual Last follow-up date 29/03/2024
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Essential Burn Life Support Training A once off 3- 4 hour training for health workers managing burn patients. 3 months Essential Burn Life Support Training- is a one -two day training offered to health workers dealing with burn patients (nurses, surgeons, therapists, nutritionists). It covers key aspects from emergency. care to rehabilitation and psychosocial care. The Interburns- Essential Burn Care Training manual will be used for this study. 100
Control Group No Intervention or Routine Care Not Applicable 3 months We will monitor outcomes under the current care. 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult and Paediatric burns patients admitted to surgical units with consent to partake in study Burns involving > 10% Body surface area Burns not infected on admission Infected burns on admission Non consenting burns patients Burns involving <10% 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Month(s) 90 Year(s) Both
Adult and Paediatric burns patients admitted to surgical units with consent to partake in study Burns involving > 10% Body surface area Burns not infected on admission Infected burns on admission Non consenting burns patients Burns involving <10% 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Month(s) 90 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 19/04/2023 University of Zambia Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality At discharge or Patient demise
Primary Outcome wound Infection at Day 0, Day 5, then weekly till discharge
Secondary Outcome Length of Hospital Stay Calculated in days at discharge or mortality
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Levy Mwanawasa University Teaching Hospital Chainama Hills, Great East Road Lusaka 10101 Zambia
University Teaching Hospital Nationalist Road Lusaka 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Royal Society of Tropical Medicine and Hygiene 303-306 High Holborn London WC1V 7JZ United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Royal Society of Tropical Medicine and Hygiene 303-306 High Holborn London WC1V IJZ United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Sharmila Dissanaike 3601 4th Street Lubbock Texas 79430 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nancy Kasongo kasongonancy2@gmail.com +260977989792 Levy Mwanawasa Hospital, Great East road
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Medical Doctor
Role Name Email Phone Street address
Scientific Enquiries Sody Mweetwa s.munsaka@unza.zm +260977925304 Nationalist road
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Chairperson University of Zambia Biomedical Research Ethics Committee
Role Name Email Phone Street address
Public Enquiries Nancy Kasongo Kasongonancy2@gmail.com +260977989792 Levy Mwanawasa University Teaching Hospital , Great East
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Medical Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial after deidentification will be available for use. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Begining after research publication upto 2 years Investigators whose proposed use of data has been approved by scientific ethics committee
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