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.: PACTR202006616535482 Date of Approval: 17/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomised controlled trial comparing silver impregnated fibrous hydrocolloid dressings to silver sulfadiazine cream dressings for the treatment of fracture blisters to determine time to surgical readiness
Official scientific title A randomised controlled trial comparing silver impregnated fibrous hydrocolloid dressings to silver sulfadiazine cream dressings for the treatment of fracture blisters to determine time to surgical readiness
Brief summary describing the background and objectives of the trial To investigate, in patients suffering from fracture blisters, the time to surgical readiness in those treated with silver impregnated fibrous hydrocolloid dressings compared to those treated with topical silver sulfadiazine cream, and to determine the direct costs associated with both treatments.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2018
Actual trial start date 01/07/2018
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date 29/02/2020
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 70
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 Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Silver sulfadiazine cream Applied daily to deroofed fracture blisters until re-epithelialisation has occurred. Approximately 20ml cream applied on average - depending on size of fracture blister area to cover Until re-epithelialisation has occurred In both treatment groups, skin preparation of the blisters was performed with povodine iodine solution and blisters were deroofed using an 18-guage needle , after which the chosen intervention was applied and then covered with sterile gauze dressings. Patients in the Silver sulfadiazine cream group received new dressings daily. Patients were deemed ready for surgery once the blister had fully re-epithelialised. The time to complete re-epithelialisation, and thus surgical readiness, was recorded. 35 Active-Treatment of Control Group
Experimental Group Silver impregnated Fibrous Hydrocolloid Dressing Applied to deroofed fracture blisters and inspected daily until blisters have re-epithelialised. Amount used is enough to cover deroofed fracture blister bed. On average 5x5cm square. Until blisters have re-epithelialised. In both treatment groups, skin preparation of the blisters was performed with povodine iodine solution and blisters were deroofed using an 18-guage needle, after which the chosen intervention was applied and then covered with sterile gauze dressings. Patients in the silver fibrous hydrocolloid group had their blisters inspected daily, but the dressing was only removed once the blister had re-epithelialised. Patients were deemed ready for surgery once the blister had fully re-epithelialised. The time to complete re-epithelialisation, and thus surgical readiness, was recorded. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Fracture blisters overlying a fracture requiring surgical intervention 18 years of age or older Fracture blisters overlying a fracture not requiring surgical intervention (conservatively managed) Patients younger than 18 years Patient refusal to participate Known povodine iodine allergy Known silver allergy Known sodium carboxymethylcellulose allergy 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 18/04/2018 HREC Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive Parow Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The aim of this study was to investigate, in patients suffering from fracture blisters, the time to surgical readiness in those treated with silver impregnated fibrous hydrocolloid dressings compared to those treated with topical silver sulfadiazine cream. On completion March 2020
Secondary Outcome A secondary aim was to determine the direct costs associated with both treatments. On completion March 2020
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Francie Van Zijl Drive Parow Cape Town 7505 South Africa
Worcester Provincial Hospital Murray Street Worcester Worcester 6850 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tygerberg Hospital Francie Van Zijl Drive Cape Town 7505 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karin Wiese karinraewiese@gmail.com 0027835994473 237 Ocean View Drive, Sea Point
City Postal code Country Position/Affiliation
Cape Town 8005 South Africa Registrar Orthopaedic Surgery
Role Name Email Phone Street address
Public Enquiries Marilize Burger marilizecb@gmail.com 0027820462614 Francie Van Zijl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Research coordinator
Role Name Email Phone Street address
Scientific Enquiries Nando Ferreira drferreiran@gmail.com 0027833245585 Francie Van Zijl Drive, Parow
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be collected on a Microsoft excel spreadsheet. The principal investigator will collect all the data and will be the only one with access to identified IPD. It will be password protected. The supervisor and biostatistician will have access to password protected de-identified patient data for a one month period as stipulated below for the sole purpose of data analysis. The principal investigator will then be responsible for writing up of results. No individual patient data will be reported on in the article but rather a collated dataset looking at medians and the overall trends. this will be in text, tables. one example of IPD will be used in the form of a figure depicting a fracture blister. This will be de-identified. Only the principal investigator will know the IPD of this figure. The principal investigator will have all informed consent sheets securely stored for a period 5 years following completion of the study and only they will have access to the sheets. Informed Consent Form The principal investigator will have access to all patient data during the time of recruitment from 01 July 2018 until 29 February 2020. From 01 March 2020 until 30 March 2020 de-identified IPD was available to the supervisor and biostatistician. Thereafter only the principal investigator will have access to IPD. The data once analyzed will be written in a report and the results thereof published in a journal. The aim is to have this completed by end of 2020. (December 2020). The results will then be available. Controlled data access only by the principal investigator to identified and de-identified IPD. The supervisor and biostatistician will have access to de-identified IPD during the time period listed above. IPD will never be available to public or other sources. once published in a journal, readers of the journal will have access to overall global de-identified results. No IPD will be accessible to the public.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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