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.: PACTR202607754538830 Date of Registration: 08/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical Evaluation of Glycerol-Preserved Human Amniotic Membrane Versus Nanocrystalline Silver Dressing (Acticoat®) in Partial-Thickness Burns: A Prospective Within-Patient Randomised Controlled Trial
Official scientific title Clinical Evaluation of Glycerol-Preserved Human Amniotic Membrane Versus Nanocrystalline Silver Dressing (Acticoat®) in Partial-Thickness Burns: A Prospective Within-Patient Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Partial-thickness burns are a significant cause of morbidity in South Africa, particularly in peri-urban communities. Nanocrystalline silver dressings such as Acticoat® are widely used in South African public sector burn units but are associated with pain during dressing changes, high consumable cost, and supply chain constraints. Human amniotic membrane (hAM) is a biologically active wound dressing derived from placental tissue that is routinely discarded following childbirth, making it an ethically accessible and potentially costeffective alternative. hAM possesses anti-inflammatory properties, growth factors that promote epithelial cell migration and proliferation, and constitutive antimicrobial activity. Glycerol-based preservation enables roomtemperature storage without cryogenic infrastructure, making it suitable for resource-constrained settings. Despite promising properties, no randomised controlled trial has directly compared glycerol-preserved hAM with a contemporary nanocrystalline silver dressing in partial-thickness burn wound management. The primary objective of this trial is to compare time to first signs of re-epithelialisation between glycerol-preserved hAM and Acticoat® in patients with partial-thickness burns, using a within-patient controlled design in which each participant serves as their own control. Secondary objectives are to compare the number of dressing changes required, patient-reported pain scores, and incidence of clinical wound infection between the two treatments.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/10/2024
Actual trial start date 01/10/2024
Anticipated date of last follow up 30/11/2026
Actual Last follow-up date 30/11/2026
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Wits HREC M220945
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Glycerol preserved human amniotic membrane 14 days Single-layer glycerol-preserved hAM applied to the wound bed with the epithelial side facing the wound, secured with non-adherent secondary dressing and sterile gauze. Left in situ without scheduled changes until natural detachment. 75
Control Group Acticoat 14 days Commercially available nanocrystalline silver-infused mesh dressing (Smith & Nephew, UK), pre-moistened with sterile water and applied per manufacturer instructions. Changed every three days or earlier if clinically indicated. 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged ≥8 years presenting within 72 hours of acute partial thickness burn injury. If they had two anatomically comparable wound sites suitable for within-patient comparison (bilateral/symmetric burns, or a single wound of sufficient area for division into two equivalent halves). Eligible sites included wounds (burns or donor sites) on the limbs, torso, face, hands, or perineum. Patients with physical and/or mental conditions that are not expected to comply with the investigation. Participation in other clinical investigation(s) within 1 month prior to and at the start of the investigation. Patients with poor prognosis or who are critically ill. Patients with full thickness burns or infected wounds. 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 8 Year(s) 80 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 10/08/2023 Wits HREC
Ethics Committee Address
Street address City Postal code Country
4th Floor, 31 Princess of Wales Terrace, Parktown, Johannesburg Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to first signs of re-epithelialisation. This is during treatment. The wounds are assessed for first signs of re-epithelialization from day 3, then continued assessment on day 6, 9, 12, and 14
Secondary Outcome Number of dressing changes The number of dressing changes made on the wounds over the 14 days of assessment during treatment.
Secondary Outcome Patient-reported pain score Patient reported pain scores are recorded at baseline or day zero when treatments are applied. Then continue to be recorded on days 3, 6, 9, 12, and 14 during treatment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath Academic Hospital 26 Chris Hani Rd, Diepkloof 319-Iq Johannesburg 1684 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
The Innovation Hub Management Company 1 Mark Shuttleworth Street The Innovation Hub Pretoria 0087 South Africa
Magitech Science 1 Mark Shuttleworth Street The Innovation Hub Pretoria 0087 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand 7 York Road, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Chris Hani Baragwanath Academic Hospital Burns Centre 26 Chris Hani Road Johannesburg 2013 South Africa
Charlotte Maxeke Johannesburg Academic Hospital 5 Jubilee Road, Parktown Johannesburg 2193 South Africa
MagiTech Science Pty Ltd 1 Mark Shuttleworth street, BioPark building, The Innovation Hub Pretoria 0087 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cleopatra Ndhlovu cleondhlovu1@gmail.com +27828528452 4261 Paisley ave, Bluevalley Golf Estate
City Postal code Country Position/Affiliation
Kosmosdal 0157 South Africa Wits PhD candidate
Role Name Email Phone Street address
Public Enquiries Lawrence Chauke lawrence.chauke@wits.ac.za +27832775201 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Study Supervisor Wits University
Role Name Email Phone Street address
Scientific Enquiries Adelin Muganza amuganza@gmail.com +27834177487 26 Chris Hani Road, Soweto
City Postal code Country Position/Affiliation
Johannesburg 1684 South Africa Study Supervisor Wits University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data that underlie the results reported in the final PhD thesis and subsequent peer-reviewed publications (including data dictionaries) will be shared. Informed Consent Form Data will become accessible beginning 12 months after the primary publication of the trial results or the awarding of the PhD degree (whichever comes first), and will remain available for a period of 5 years. Requests must be submitted directly to the Principal Investigator (PhD Candidate) or the primary Wits University supervisor.
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 01/07/2026 each criteria on new line Patients aged ≥8 years presenting within 72 hours of acute partial thickness burn injury. If they had two anatomically comparable wound sites suitable for within-patient comparison (bilateral/symmetric burns, or a single wound of sufficient area for division into two equivalent halves). Eligible sites included wounds on the limbs or torso; burns or donor sites involving the face, hands, or perineum. Patients aged ≥8 years presenting within 72 hours of acute partial thickness burn injury. If they had two anatomically comparable wound sites suitable for within-patient comparison (bilateral/symmetric burns, or a single wound of sufficient area for division into two equivalent halves). Eligible sites included wounds (burns or donor sites) on the limbs, torso, face, hands, or perineum.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 01/07/2026 each criteria on new line Patients with physical and/or mental conditions that are not expected to comply with the investigation. Participation in other clinical investigation(s) within 1 month prior to and at the start of the investigation. Patients with poor prognosis or who are critically ill. Patients with physical and/or mental conditions that are not expected to comply with the investigation. Participation in other clinical investigation(s) within 1 month prior to and at the start of the investigation. Patients with poor prognosis or who are critically ill. Patients with full thickness burns or infected wounds.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/07/2026 clarification for reviewer Primary Outcome, Time to first signs of re-epithelialisation, Assessed on days 0, 3, 6, 9, 12, and 14 Primary Outcome, Time to first signs of re-epithelialisation, The wounds are assessed for first signs of re-epithelialization from day 3, then continued assessment on day 6, 9, 12, and 14
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/07/2026 clarification for reviewer Primary Outcome, Time to first signs of re-epithelialisation, The wounds are assessed for first signs of re-epithelialization from day 3, then continued assessment on day 6, 9, 12, and 14 Primary Outcome, Time to first signs of re-epithelialisation. This is during treatment. , The wounds are assessed for first signs of re-epithelialization from day 3, then continued assessment on day 6, 9, 12, and 14
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/07/2026 clarification for reviewer Secondary Outcome, Number of dressing changes , Recorded over 14 days Secondary Outcome, Number of dressing changes , The number of dressing changes made on the wounds over the 14 days of assessment during treatment.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/07/2026 clarification for reviewer Secondary Outcome, Patient-reported pain score, Assessed on days 0, 3, 6, 9, 12, and 14 Secondary Outcome, Patient-reported pain score, Patient reported pain scores are recorded at baseline or day zero when treatments are applied. Then continue to be recorded on days 3, 6, 9, 12, and 14 during treatment.