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.: PACTR202308874091441 Date of Approval: 25/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A study comparing antimicrobial sutures with regular sutures in prevention of infection following cranial surgery
Official scientific title A comparative analysis of antimicrobial sutures and conventional sutures in the prevention of cranial surgical site infection
Brief summary describing the background and objectives of the trial BACKGROUND: Surgical site infection (SSI) is a major challenge to safe surgical practice resulting in significant morbidity and preventable death. The use of triclosan-coated sutures for wound closure has been recommended in the prevention of SSI in the field of surgery. However, the results of its efficacy in SSI prevention appear conflicting, and there is a paucity of studies to evaluate its role in cranial surgery, which may partly explain its non-adoption. This suggests the need for local clinical trials to evaluate its effect in the prevention of SSI following cranial surgery. OBJECTIVE: To compare the effect of triclosan-coated sutures with conventional sutures for wound closure in the prevention of SSIs after cranial surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2023
Actual trial start date 01/09/2023
Anticipated date of last follow up 31/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Triclosan coated Vicryl sutures One time event (wound closure) Not applicable, the sutures will be absorbed by the body At the time of wound closure, patients randomised into the experimental group will have the deep layer of the scalp (galea aponeurotica and subcutaneous layer) closed in a simple continuous pattern with a buried knot using triclosan-coated suture, Vicryl® Plus (polyglactin 910) 2/0, with the skin closed using staples. 50
Control Group Regular vicryl sutures The sutures will be left insitu and will be absorbed by the body Patients randomised into the control group will have the deep layer (galea aponeurotica and subcutaneous layer) of the scalp closed in a simple continuous pattern with buried knots using regular Vicryl® suture, (polyglactin 910) 2/0, with the skin closed using staples. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 2–80 years. Consenting patients who are scheduled for cranial surgical procedures under general anaesthesia requiring scalp incisions All patients for cranial surgical procedures with class I wounds as defined by the American College of Surgeons and without evidence of systemic focus of infection Patients with controlled comorbidities Patients with an intracranial or systemic infection before the procedure Patients with contaminated or dirty surgical wounds Patients who die within 30 days after surgery from complications unrelated to SSIs Patients on long-term steroid use (> 1 month) or with uncontrolled co-morbidities Patients undergoing surgery with the use of implants Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 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 23/03/2023 Obafemi Awolowo University Teaching Hospitals Complex Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Ilesha Road Ile Ife 220101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be the surgical site infection rate reported by blinded assessors within 30 days of surgery, which will be compared in both groups. Within 30 days
Secondary Outcome The length of hospital stay in those with surgical site infection and the pattern of causative microorganism Within 30 days of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex. Ilesa Road Ife Osun state 220101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR CHIZOWA OKWUCHUKWU EZEAKU ILESHA ROAD ILE IFE 220101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr CHIZOWA OKWUCHUKWU EZEAKU ILESHA ROAD ILE IFE 220101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHIZOWA EZEAKU ezeakuchizowa@gmail.com +2348080054944 Phase 2, Ilesha Road
City Postal code Country Position/Affiliation
ILE IFE 220101 Nigeria PRINCIPAL INVESTIGATOR
Role Name Email Phone Street address
Scientific Enquiries EDWARD KOMOLAFE eokomolafe@hotmail.com +2348033447326 Phase 4, OAUTHC
City Postal code Country Position/Affiliation
ILE IFE 220101 Nigeria POFESSOR AND HEAD NEUROSURGERY DEPARTMENT OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX
Role Name Email Phone Street address
Public Enquiries CHIZOWA EZEAKU ezeakuchizowa@gmail.com +2348080054944 Phase 4 OAUTHC
City Postal code Country Position/Affiliation
ILE IFE 220101 Nigeria DIVISION OF NEUROSURGERY OBAFEMI AWOLOWO UNIVERSITY HOSPITALS COMPLEX
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial, will be made available after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol This will be from completion of data collection and publication up to 5 years Researchers who wishes to access the data
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