Hadassah University Medical Center, Ein Karem Campus
Jerusalem, 9112001, Israel
Location status: Recruiting
NCT Number: NCT07483411
The goal of this randomized control trial is to compare two skin closure techniques after cesarean section. Both techniques are currently in wide use but no comparison between the two was reasserted yet. The two techniques are- First technique is intracuticular suture using monofilament suture, Second technique is intracuticular suture and biological adhesive material. The investigators' primary outcome is to explore the rate of skin scar complications to understand whether one technique has a lower complication rate then the other. The secondary outcomes is to check whether one technique is better then the other in terms of patients' satisfaction, convenience and scar healing and appearance.
Patients at the age of 18 and above, undergoing elective cesarean section at the Hadassa medical center, can participate.
participants will be randomly assigned to one of the groups- the firs or the second technique.
Patients will be asked to fill out a questionnaire on POD 2 and attend a check-up appointment in-person with their surgeon 6-8 weeks post surgery. at the check-up the patient will be asked to fill out another questionnaire and undergo a scar appearance evaluation by the surgeon.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Jerusalem, 9112001, Israel
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is the addition of skin adhesive biological material on top of an intracuticular suture in skin closure after cesarean section
Other names: skin adhesive material
Time frame: From the surgery and up to 8 weeks post surgery
Any skin complications including superficial infection, deep infection, seroma, skin open, the need for antibiotics and skin related complaints including rash, itching, discharge.
Time frame: From the day of the surgery up to 8 weeks post surgery
The investigators will assess the satisfaction of the patient on POD 2 using a Likert score based questionnaire designed for the study. Each question is graded between 0-10, the summery of all questions is the grade of the questionnaire
Time frame: 6-8 weeks post surgery
The investigators will assess the satisfaction of the patient 6-8 weeks post the surgery using the POSAS 3.0 (patient & observer scar assessment scale)- the patient questionnaire for generic scar. the score for this questionnaire rages between 16 to 80, the lower the score, the better scar outcomes
Time frame: 6-8 weeks post surgery
The investigators will assess the scar healing and appearance using the Vancouver Scar Scale 6-8 weeks post surgery. the assessment will be made by the surgeon, in person. The grade for this questionnaire ranges between 0 and 13, the lower the score, the better outcome.
Contact information is provided by the study sponsor or research team.
Doron Kabiri, MD, MPH
CONTACT
Efrat Shekel, MD
CONTACT
Doron Kabiri
Other
Intracuticular Suture Alone Compared to Intracuticular Suture and Skin Adhesive Material for Skin Closure After Cesarean Delivery : a Prospective Randomized Control Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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