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.: PACTR202407734894108 Date of Approval: 23/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of surgical site infections following early and delayed exposure of caesarean section wound in FCTA hospitals, Abuja, Nigeria
Official scientific title Comparison of surgical site infections following early and delayed exposure of caesarean section wound in FCTA hospitals, Abuja, Nigeria
Brief summary describing the background and objectives of the trial Background: Caesarean delivery is the most performed surgery in women of reproductive age and the rate continues to rise globally. Surgical site infection (SSI), the most common Healthcare - acquired infection (HAI) is a major complication of caesarean section (C/S), it increases maternal morbidity, hospital stay as well as unplanned hospital cost. Wound dressing is usually applied on caesarean section wounds but there is conflicting evidence on the duration in which the wound should be left covered to reduce the rate of SSI. Aim: To compare the incidence of surgical site infection following early (intervention) versus delayed (control) exposure of caesarean section wound in Asokoro District Hospital (ADH) and Maitama District Hospital (MDH), Abuja. Nigeria Subjects and Methods: this will be a multi-cantered randomized control trial. Ethical clearance will be obtained from the hospital ethical committee. Only booked patients who are to undergo elective caesarean section in the obstetrics and gynaecology unit at ADH/MDH will be evaluated. Those that meet the inclusion criteria will be randomized using computerized random numbers and simple randomization into two groups: early wound exposure at 24 hours (Group A) and delayed wound exposure on day 3 post caesarean section (Group B). The wound will be examined on the 3rd, 10th, 21st and 30th-day post-surgery for signs of SSI. The total sample size will be 230 (115 in each arm). A p-value of < 0.05 will be considered statistically significant. The data will be analysed statistically using SPSS version 2021. Result: will be drawn from the data analysis Conclusion: will be drawn from the result of the study
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied surgical site infections following caesarean section
Purpose of the trial Education /Training
Anticipated trial start date 13/09/2022
Actual trial start date 14/11/2022
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date 31/03/2023
Anticipated target sample size (number of participants) 230
Actual target sample size (number of participants) 230
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 a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 24 HOURS TO 30 DAYS POST OPERATION THE SURGICAL WOUND WAS EXPOSED AT 24 HOURS POST OPERATION AND PARTICIPANTS WERE FOLLOWED UP FOR 30 DAYS POST SURGERY TO CHECK FOR SIGNS AND SYMPTOMS OF SURGICAL SITE INFECTION AFTER SURGERY 115
Control Group GROUP B 3 DAYS TO 30 DAYS POST OPERATION WOUND WAS EXPOSED AT 3 DAYS POST OPERATION AND PARTICIPANTS WERE FOLLOWED UP FOR 30 DAYS POST SURGERY TO CHECK FOR SIGNS AND SYMPTOMS OF SURGICAL SITE INFECTION 115 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged ≥18 years to ≤ 45 years having primary, first repeat and second repeat elective caesarean section. Any other skin incision other than Pfannenstiel Prior surgical site infection Pyrexia before surgery Prelabour rupture of membrane BMI ≥35kg/m 2 Wound drain in-situ Declined consent Diabetes in pregnancy HIV in pregnancy Sickle cell disease in pregnancy Antepartum hemorrhage Duration of surgery greater than I hour Anaemia (PCV < 30%) Any C/S that results in another procedure due to complications Allergy to Durapore Adhesive tape Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 19/07/2022 federal capital territory health research ethics committee
Ethics Committee Address
Street address City Postal code Country
no 1 kapital street 11, Garki Abuja 900247 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome was the presence of surgical site infection as defined by the Centre for Disease control and Prevention. primary outcome was measured from 24 hours to 30 hours post caesarean section while secondary outcome was measured on the 2nd post operative day
Secondary Outcome The secondary outcome was patients’ comfort level. SECOND DAY POST OPERATION
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ASOKORO DISTRICT HOSPITAL JULIUS NYEREYE ABUJA Nigeria
MAITAMA DISTRICT HOSPITAL AGUIYI IRONSI STREET ABUJA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SORELY FUNDED BY THE RESEACHER MAITAMA DISTRICT HOSPITAL ABUJA Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EKANEM UDUAK SUNDAY PRINCIPAL INVESTIGATOR MAITAMA DISTRICT HOSPITAL ABUJA Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator UDUAK EKANEM PRINCESSUSUNGIMO12@GMAIL.COM 07035491171 BHD 69 ROAD, GWARINPA
City Postal code Country Position/Affiliation
ABUJA Nigeria SENIOR REGISTRAR MAITAMA DISTRICT HOSPITAL
Role Name Email Phone Street address
Scientific Enquiries OLUGBENGA BELLO belloolu123@gmail.com 08023230067 JULIUS NYEREYE
City Postal code Country Position/Affiliation
ABUJA Nigeria CONSULTANT ASOKORO DISTRICT HOSPITAL
Role Name Email Phone Street address
Public Enquiries OLAJUMOKE OGUNMOLA aquilajmk@yahoo.com 08062198050 JULIUS NYERERE
City Postal code Country Position/Affiliation
ABUJA Nigeria SENIOR REGISTRAR ASOKORO DISTRICT HOSPITAL
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trail will be shared after deidentification Informed Consent Form,Study Protocol immediately following publication. No end date. Any one who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available 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