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.: PACTR201903775777250 Date of Approval: 28/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EARLY OUTCOMES OF POST OPERATIVE HIP AND PROXIMAL THIGH WOUNDS DRESSED WITH POST-OP OPSITE™ VERSUS POVIDONE-IODINE BASED DRESSING; A RANDOMIZED TRIAL
Official scientific title EARLY OUTCOMES OF POST OPERATIVE HIP AND PROXIMAL THIGH WOUNDS DRESSED WITH POST-OP OPSITE™ VERSUS POVIDONE-IODINE BASED DRESSING; A RANDOMIZED TRIAL
Brief summary describing the background and objectives of the trial Management of clean surgical wounds involves use of adequate post-operative wound dressings. The ideal wound dressings should have the following characteristics, it should create a moist, clean, and warm environment which is good for wound healing, be able to provide hydration if the wound is dry or if the wound is desiccated, remove excess exudates, be non-traumatic, provide protection for the peri-wound area and allow gaseous exchange, other properties are ;it must be impermeable to micro-organisms, being free of irritant or toxic particles and should conform to the body contour ,patients should have minimal pain during application and removal, it must be easy to use and be cost effective. In my hospital (University College Hospital, Ibadan), povidone iodine based sterile cotton gauze dressings is used for wound dressings except in arthroplasty surgeries in which composite wound dressings are used. The povidone iodine based sterile gauze dressings consists of an inner layer of povidone iodine (an antiseptic) soaked gauze, followed by a middle absorbent layer of plain sterile gauze and then an outer layer of adherent plaster. It provides a barrier to bacteria including MRSA, it reduces the risk of maceration. It reduces blistering, reduces pain on removal, It is water proof, conformable and comfortable to wear. This is due to the reduced bulk which makes it easy to apply and remove, it manages exudate through a highly absorbent pad and breathable film, it is easy to apply and remove aseptically. The study will compare the early outcomes of wounds around the hip and proximal thigh dressed in post-op opsite with wounds dressed in povidone iodine-based gauze. Specifically to compare the rate of wound maceration, skin reaction and formation of blisters between the use of conventional wound dressings and post-op opsite; the number of changes of wound dressings between the two methods of wound dressings and the pain score during change of wound dressings
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,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2019
Actual trial start date
Anticipated date of last follow up 30/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 98
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Post operative opsite dressing versus povidone iodine based dressing Not applicable five days Povidone iodine based gauze dressings 49 Active-Treatment of Control Group
Experimental Group Post operative opsite dressing versus povidone iodine based dressing Not applicable five days Pre-fabricated post-operative op-site 49
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting patients undergoing surgeries around the hip and proximal thigh that are eighteen years and older. Patients would have to be on the ward for a minimum of five days Patients with open wounds Patients with pre-operatively compromised skin in the region of the surgery Patients with skin lesions at the surgical site Patients with bleeding disorders or on long term anticoagulant therapy Patient with dementia, psychiatric problems who may interfere with the wound 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 10/12/2018 UIUCH Research ethics committee
Ethics Committee Address
Street address City Postal code Country
Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan Ibadan 5116 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of surgical site infection 5 days
Secondary Outcome Skin maceration (presence or absence) peri wound blistering (presence or absence) Wound dressing loosening/ displacement (presence or absence) Pain score during change of wound dressings Number of changes of wound dressing before removal of stitches 5 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Department of Orthopaedics and Trauma Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self University College Hospital Ibadan Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adeoye AllenTaylor University College Hospital, Ibadan Ibadan Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Promise Jaja University College Hospital Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Promise Jaja projat@hotmail.com +2348030804035 University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Neurological Surgery Resident
Role Name Email Phone Street address
Principal Investigator Adeoye AllenTaylor deoyeallentaylor@gmail.com +2348060918597 University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Orthopaedics and Trauma Resident
Role Name Email Phone Street address
Public Enquiries Promise Jaja projat@hotmail.com +2348030804035 University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Neurological Surgery Resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD for this study will contain de-identified bio data information as well as the outcome measures for the study Study Protocol The IPD will be available between 6-12 months following completion of study, when the publication of the study is expected to be out The IPD will initially have controlled access and later open. Requests for access will be reviewed by one of the investigators. There may be no restrictions on statistical analysis. Access will be granted based on the relevance of the study the data will be needed for, as judged by the protocol and the qualification of the authors.
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