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.: PACTR202407496762405 Date of Approval: 26/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomised Controlled Trial of Cyanoacrylate Glue Versus Vicryl for skin closure at Caesarean Section at Federal Teaching Hospital, Katsina
Official scientific title A Randomised Controlled Trial of Cyanoacrylate Glue Versus Vicryl for skin closure at Caesarean Section at Federal Teaching Hospital, Katsina
Brief summary describing the background and objectives of the trial Caesarean Section rate is on the rise over the last four decades. Emphasis is now being placed on the cosmesis by the women partly because of the rate of repeat Caesarean Section. Over the years there were no studies that showed the best method or material for skin closure at Caesarean Section. Use of sutures (Absorbable and Non-absorbable), tissue adhesive glues and stapler for skin closure were at the Surgeons' discretion. Some studies have shown better scar cosmesis with N-butyl cyanoacrylate glue compared with standard procedure (vicryl suture), while others showed no significant difference. However most of the studies were Retrospective and/or not Randomized. SPECIFIC OBJECTIVES 1. To compare the scar cosmesis between patients who had skin closure using subcuticular vicryl 2/0 versus N-butyl cyanoacrylate glue after Caesarean section. 2. To compare the duration of skin closure during Caesarean section between patients who had subcuticular vicryl 2/0 versus N-butyl cyanoacrylate glue. 3. To compare the pain intensity after Caesarean section between patients who had skin closure using subcuticular vicryl 2/0 versus N-butyl cyanoacrylate glue. 4. To compare the rate of wound complications among patients who had skin closure using subcuticular vicryl 2/0 versus N-butyl cyanoacrylate glue at Caesarean section. 5. To compare the patients’ and surgeons’ satisfaction with skin cosmesis among those who had skin closure using subcuticular vicryl 2/0 versus N-butyl cyanoacrylate glue.
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 Skin closure at Caesarean Section
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/04/2024
Actual trial start date 29/07/2024
Anticipated date of last follow up 01/07/2024
Actual Last follow-up date 30/10/2024
Anticipated target sample size (number of participants) 70
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 Dynamic (adaptive) random allocation such as minimization 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 Use of N butyl cyanoacrylate glue for skin closure at Caesarean Section 0.5-1ml over the wound start At skin closure following Caesarean Section N butyl Cyanoacrylate glue will be used to close the skin. 35
Control Group Subcuticular Vicryl Start Start Use of Subcuticular vicryl 2 0 to close the skin at Caesarean Section 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of FMCK undergoing Caesarean section with Pfannenstiel or Joel Cohen skin incision between the ages of 18 and 45 years, from 28 weeks 0 days to 41 weeks 6 days of gestation. Patients with the following will be excluded: 1. Previous hypersensitivity to N-butyl cyanoacrylate glue 2. Asthmatic patients 3. Extremes of maternal weight; <45kg and >90kg 4. Diabetes mellitus 5. Anaemia; PCV <30% 6. Cigarette smoking and chronic alcohol consumption 7. Suspected or confirmed chorioamnionitis 8. Prolonged pre-labor rupture of membrane (pPROM) of >24hrs 9. Patients with Intra uterine fetal death (IUFD) 10. Obstructed labour 11. Keloid scarring 12. Immunosuppressive disease conditions e.g., HIV, Systemic Lupus Erythematosus (SLE), Anti phospholipid syndrome, multiple sclerosis 13. Immunosuppressive treatment e.g., prolonged use of systemic steroids >3 months 14. Primary or previous Caesarean section not using Pfannenstiel or Joel Cohen incision 15. Do not consent to participate in the study. Adult: 19 Year-44 Year 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 05/02/2024 Federal Medical Center Katsina ethical committee
Ethics Committee Address
Street address City Postal code Country
Jibia road, Katsina, Nigeria Katsina 820101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measure To compare the scar outcome on day 5 (SCAR1) and at 6 weeks (SCAR2) post-operatively using SCAR scale in both the study and control group. Day 5- 6weeks postpartum
Secondary Outcome Secondary outcome measures 1. To compare the time taken for skin closure in both the study and control group. 2. To compare self-assessed pain 6 hours post-operatively using NPRS in both the study and control group. 3. To compare wound complications (wound dehiscence and superficial surgical site infection) at day 5 and at 6 weeks post operation in both the study and control group. 4. To assess and compare the patient’s and surgeons’ satisfaction using Scar VSS in both the study and control group. Day 1-6weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Center Katsina Murtala Mohammed Way, Jibiya Bypass, Katsina. Katsina PMB 2121 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adamu Saminu Adamu Bayajidda Quarters Katsina. Katsina Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adamu Saminu Adamu Bayajidda Quarters Katsina Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adamu Saminu Adamu adamusaminu1984@gmail.com +2348032880636 Bayajidda Quarters Katsina
City Postal code Country Position/Affiliation
Katsina Nigeria Senior Registrar Obstetrics
Role Name Email Phone Street address
Scientific Enquiries Jamilu Tukur jtukur@yahoo.com +2348037042818 Murtala Mohammed Way, Jibiya Bypass Katsina
City Postal code Country Position/Affiliation
Katsina Nigeria Prof. of Gynaecology
Role Name Email Phone Street address
Public Enquiries Yusuf Shuaibu adamsadam2000@yahoo.com +2348035923946 Murtala Mohammed Way, Jibiya Bypass Katsina.
City Postal code Country Position/Affiliation
Katsina Nigeria Consultant Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices) will be shared. Clinical Study Report,Informed Consent Form,Study Protocol IPD will be shared Immediately following publications, no end date. Anyone who wishes to access the data for any purpose and data will be available indefinitely.
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