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.: PACTR201401000697382 Date of Approval: 05/11/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title SSI in CS
Official scientific title COMPARATIVE STUDY OF ANTISEPTIC SKIN PREPARATION FOR PREVENTING SURGICAL SITE INFECTION AT CAESAREAN SECTION: A RANDOMISED CONTROL TRIAL
Brief summary describing the background and objectives of the trial The study aims to compare the effect of two different antiseptic skin preparations- chlorhexidine-alcohol and povidone iodine on surgical site infection rates post caesarean section. It aims to determine the proportion of subjects with surgical site infection following caesarean section in OAUTHC, Ile-Ife; to compare the relative effectiveness of the two antiseptic skin preparation in preventing surgical site infection at caesarean and to determine the rate of skin reaction to both antiseptics
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgical site infection
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2012
Actual trial start date 13/08/2012
Anticipated date of last follow up 01/04/2013
Actual Last follow-up date 03/06/2013
Anticipated target sample size (number of participants) 284
Actual target sample size (number of participants) 374
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ERC/2012/05/05 Ethics and research committee (ERC) OAUTHC, Ile-Ife, Nigeria
IRB/IEC/0004553 International research and ethical committee
NHREC/27/02/2009a Nigerian health research and ethical committee
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 using a radomisation table created by a computer software program sealed opaque envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Povidone iodine Cleaning once Allowed to dry A centrifugal scrubbing motion was used starting from the area of the intended incision and covered the abdomen from the subcoastal margin to the midaxillary line down to the middle of the thigh. The povidone iodine was painted on the aforementioned area and then left to dry completely 186
Experimental Group Chlorhexidine-alcohol Cleaning thrice Dried immediately A centrifugal scrubbing motion was used starting from the area of the intended incision and covered the abdomen from the subcoastal margin to the midaxillary line down to the middle of the thigh. The chlorhexidine-alcohol was then dried completely. This was repeated twice. 188
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women scheduled for elective caesarean section Refusal of the patient to participate Known allergy/hypersensitivity to chlorhexidine or povidone-iodine Immunocompromised patients e.g. patients with HIV, diabetes mellitus, malnourished patients and patients on long term steroid therapy Previous midline scar 18 Year(s) 45 Year(s) Female
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 03/05/2012 Ethics and research commitee, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife
Ethics Committee Address
Street address City Postal code Country
Ilesa road Ile-Ife 1000000 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Development of surgical site infection Day 3 Day 7 Week 2 Week 3 Week 4
Secondary Outcome Development of skin reaction Day 0 Day 3 Day 7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Ilesa road Ile-Ife 1000000 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Obafemi Awowolowo University Teaching Hospital Complex Ilesa road Ile-Ife 1000000 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obafemi Awowolowo University Teaching Hospital Complex Ilesa road Ile-Ife 1000000 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Wesley Guild Hospital Bolodunro Ilesa 1000001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olufemi Aworinde aworindeolufemi@yahoo.com +2348035925195 Ilesa road
City Postal code Country Position/Affiliation
Ile-Ife 1000000 Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Olufemi Aworinde aworindeolufemi@yahoo.com +2348035925195 Ilesa road
City Postal code Country Position/Affiliation
Ile-Ife 1000000 Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Ernest Orji eoorji11@yahoo.com +2348033567451 Ilesa road
City Postal code Country Position/Affiliation
Ile-Ife 1000000 Nigeria Consultant obstetrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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