Skin Adhesive Plus Intra-cuticular Suture Versus Suture Alone for Cesarean Skin Closure
ConditionSurgical Site Infection (SSI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDoron Kabiri
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients undergoing elective cesarean section at Hadassa medical center
Patients undergoing elective cesarean section btween 37+0/7 and 41+6/7 weeks of gestation
Disqualifiers
Patients undergoing emergency cesarean section
patients undergoing cesarean section before 37+0/7 weeks of gestation
patients with a history of previous wound complications after previous Caesarean section
Trial design
Design model
Parallel
Treatments tested in this trial
Dermabond
Other interventionThe intervention is the addition of skin adhesive biological material on top of an intracuticular suture in skin closure after cesarean section
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Skin closure using intracuticular suture aloneNo intervention 0 interventions
Group B: Skin closure using intracuticular suture and biological adhesive material in additionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Skin wound complecations
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 surgery and up to 8 weeks post surgerySecondary outcomes
1
Recovery and connivance of the patient at POD 2
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
From the day of the surgery up to 8 weeks post surgery2
Patients' satisfaction from their recovery and scar healing process 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 surgery3
Scar appearance after 6-8 weeks
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.
Time frame
6-8 weeks post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Doron Kabiri
Lead sponsor
Hadassah Medical Organization
Sponsor institution
Source ClinicalTrials.gov