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.: PACTR202407540567857 Date of Approval: 11/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Subcuticular Polyglactin Suture Versus Staple For Skin Closure After Caeseraen Section At Asokoro District Hospital Abuja: A Randomised Controlled Trial
Official scientific title Subcuticular Polyglactin Suture Versus Staple For Skin Closure After Caesarean Section At Asokoro District Hospital Abuja: A Randomised Controlled Trial
Brief summary describing the background and objectives of the trial Caesarean section is the most common life-saving surgical procedure done in obstetrics. It is imperative that the surgical technique should be carefully tailored to the patient’s satisfaction. Technique of skin closure after Caesarean section has not changed much even in modern obstetrics where there are innovations for safer and better outcome. The ideal skin closure should be safe, fast, simple, and cost effective, while taking into consideration the patient’s satisfaction. Although, a lot of studies have been done on skin closure after Caesarean section using either subcuticular technique or staples, there is still conflicting and inconclusive evidence as regards the best method of skin closure in terms of less postoperative pain, wound complications, cosmesis, and patient’s satisfaction. Aim; 1.To compare the outcome of skin closure after Caesarean section using staple and subcuticular sutures among women attending Asokoro District Hospital, Federal Capital Territory, AbujaTo determine the post-operative pain score, wound outcome, patient’s satisfaction, time of skin closure, scar cosmesis, and cost after CS among patients undergoing skin wound closure using staples. 2. To determine the post-operative pain score, wound outcome, patient’s satisfaction, time of skin closure, scar cosmesis, and cost after CS among patients undergoing skin wound closure using subcuticular sutures. 3. To compare the post-operative pain score, wound outcome, patient’s satisfaction, time of skin closure, scar cosmesis, and cost after CS among patients undergoing skin wound closure using staples and those undergoing skin wound closure using subcuticular sutures after CS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin closure after Caesarean section
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/08/2023
Actual trial start date 29/03/2024
Anticipated date of last follow up 05/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 184
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group secondary wound closure secondary wound closure when the wound is clean if wound dehiscence is more than 3cm ,it will be sutured 92 Active-Treatment of Control Group
Experimental Group wound closure once when the wound dehiscence is more than 3cm, it will be re-sutured when the wound dehiscence is more than 3cm, it will be re-sutured 92
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
consenting adult in index pregnancy planned for elective caesarean section with no added risk factors for infection Declined consent 2. Anaemia (pre-operative haemoglobin level less than 10g/dl) 3. HIV positive 4. Diabetes Mellitus 5. Obesity (Body Mass Index at delivery >35 kg/m2) 6. Cigarettes smoking 7. Have chorioamnionitis or any overt infection 8. Have intrauterine foetal death 9. Hypertrophic /keloid scar 10. Patients on steroids 11. Sickle cell anaemia Adult: 19 Year-44 Year 18 Year(s) 44 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 15/05/2023 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
No 1 Kapital Street, Area 11,Garki, Abuja Federal Capital Territory 900103 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative pain day 2 and day 5 wound outcome day 2 and 5 post operation
Secondary Outcome patients satisfaction, operation time and scar outcome 6 weeks postoperation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Asokoro District Hospital 11 Julius Nyerere Crescent, Off Yakubu Gowon Crescent, Asokoro. Federal Capital Territory 900103 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ogunmola Mercy Asokoro District Hospital FCT 900103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ogunmola Mercy Asokoro District Hospital FCT 900103 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mercy Ogunmola olajumokeogunmola@gmail.com +2348062198050 11 julius nyekere cresecent,abuja
City Postal code Country Position/Affiliation
abuja 900103 Nigeria researcher
Role Name Email Phone Street address
Public Enquiries Olugbenga Bello belloolu123@gmail.com +2348023230067 Asokoro District Hospital
City Postal code Country Position/Affiliation
Abuja 900103 Nigeria chief Consultant Supervisor
Role Name Email Phone Street address
Scientific Enquiries Francis Alu drfrankalu@yahoo.com +2348037206243 Asokoro District Hospital
City Postal code Country Position/Affiliation
FCT 900103 Nigeria Chief Consultant surpervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data Sharing Statement: We are committed to promoting transparency and advancing scientific knowledge through data sharing. In accordance with this commitment, individual participant data collected during the randomized controlled trial comparing subcuticular versus staple skin closure after cesarean section will be made available upon reasonable request. Researchers interested in accessing the individual participant data should submit a formal request to the Principal Investigator of the study. Requests will be reviewed by the study team to ensure compliance with ethical and legal requirements, as well as protection of participant confidentiality. Upon approval, access to the individual participant data will be provided in a secure and anonymized format, with identifiers removed to protect participant privacy. Data sharing will be facilitated through a secure platform or data repository, and users will be required to sign a data-sharing agreement outlining terms of use and confidentiality obligations. We believe that sharing individual participant data will enable independent verification of study findings, facilitate meta-analyses, and contribute to the advancement of evidence-based practice in obstetrics and gynecology. For inquiries regarding data access or further information, please contact Mercy Olajumoke Ogunmola,,olajumokeogunmola@gmail.com Informed Consent Form 1 year all consenting women scheduled for elective caesarean section in Asokoro district hospital
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