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.: PACTR202308768448394 Date of Approval: 14/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Skin Wound outcome Closure Using Tissue Adhesives Versus Subcuticular Absorbable Sutures at Elective Caesarean Section
Official scientific title Skin Wound outcome Closure Using Tissue Adhesives Versus Subcuticular Absorbable Sutures at Elective Caesarean Section: Randomized controlled trial
Brief summary describing the background and objectives of the trial Background Surgical wound closure is an integral step of caesarean delivery as it influences several aspects of the postoperative course of patients including: postoperative pain, wound healing, wound complications, cosmetic outcome and patient satisfaction. Over the years, various skin wound closure techniques have been used. However, there is still no definite evidence regarding the best method for skin closure after Caesarean section. Aim: This study will compare the use of tissue adhesives with subcuticular absorbable sutures for skin wound closure to determine patients’ satisfaction and cosmetic outcome of each technique at discharge and at 6 weeks post operation following assessment by the patients and an independent observer using a validated assessment scale.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Skin Glue
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 05/05/2022
Actual trial start date 30/08/2022
Anticipated date of last follow up 29/03/2023
Actual Last follow-up date 03/04/2023
Anticipated target sample size (number of participants) 172
Actual target sample size (number of participants) 190
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group skin Glue 1 pack of Dermabond (Ethicon Inc, Somerville,NJ) two to three minutes Dermabond (Ethicon Inc, Somerville,NJ) will be used to close the skin 95
Control Group suture one pack of Vicryl (polyglactin 910 suture; Ethicon, Somerville, NJ) 2-0 variable In the suture group, the skin will be apposed with Vicryl (polyglactin 910 suture; Ethicon, Somerville, NJ) 2-0 placed under the skin using the subcuticular suturing technique 95 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 18 years and above  With no known co-existing medical condition  With ability and willingness to give consent  Willing to return for follow up evaluation previous CS using midline incision  Clinical signs of infection at the time of CS including: Fever, abdominal tenderness and foul-smelling vaginal discharge.  Uncontrolled diabetes mellitus (defined as Haemoglobin A1c > 6%, poorly controlled blood glucose measurements, and fasting glucose >95 mg/dl),  history of keloids formation  known hypersensitivity to any of the suture materials or tissue adhesives to be used in the protocol  tattoos on skin area to be studied  BMI ≥30kg/m2 at recruitment  Any disorders requiring chronic corticosteroids or immune suppressants.  Other conditions that impair wound healing like Sickle cell Anaemia, Other causes of anaemia, HIV 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 05/04/2022 UI UCH Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Queen Elizabeth II road, Agodi Ibadan 5116 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare skin wound cosmetic appearance following elective caesarean delivery using modified patient and observer scar assessment scale (POSAS) among randomized patient groups six weeks post-caesarean section
Secondary Outcome post-operative pain, duration of surgery, duration of hospitalization after the CS, complications such as surgical site infection (SSI) or wound disruption (hematoma or seroma), patients’ and surgeons’ satisfaction scales Varied
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College hospital Queen Elizabeth II road, Agodi Ibadan 5116 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ifebude Joshua Flatlet 71, UCH quarters Ibadan 5116 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ifebude Joshua Flatlet 71, UCH Quarters Ibadan 5116 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joshua Ifebude joshuaifebude@gmail.com +2348160882757 Flatlet 71, UCH Quarters
City Postal code Country Position/Affiliation
Ibadan 5116 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Yinka Ogunbode yinkogunbode@yahoo.co.uk +2348023258010 Dept of obstetrics and gynecology, UCH
City Postal code Country Position/Affiliation
Ibadan 5116 Nigeria Consultant University College Hospital
Role Name Email Phone Street address
Scientific Enquiries Yinka Ogunbode yinkaogunbode@yahoo.co.uk +2348023258010 Dept of Obstetrics and Gynecology, UCH
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant University College hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this trial will be provided to qualified researchers with interest in surgical skin wound outcome assessment. Data to be shared will be coded. There will be no protected health information(PHI) included. Approval of request and execution of data sharing will be done following fulfillment of applicable agreement(i.e. a material transfer agreement) by the requesting party Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol ten months Access to trial IPD can be requested by qualified researchers engaging in independent scientific research. This will be provided following review and approval of a research proposal and statistical analysis plan(SAP) with execution of a data sharing agreement (DSA). For more information or to submit a DSA request, please contact joshuaifebude@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://us.docworkspace.com/d/sIHv1-dkl5LPFpgY?sa=e1&st=0t 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