Surgical Site Infection (SSI)
Conditions
Keywords
cesarean section, biological adhesive, intracuticular suture, Obstetrics surgical site infection
Brief summary
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.
Interventions
OTHERDermabond
The intervention is the addition of skin adhesive biological material on top of an intracuticular suture in skin closure after cesarean section
Sponsors
Doron Kabiri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin wound complecations | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery and connivance of the patient at POD 2 | 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 |
| Patients' satisfaction from their recovery and scar healing process 6-8 weeks post surgery | 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 |
| Scar appearance after 6-8 weeks | 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. |
Countries
Israel
Contacts
CONTACTEfrat Shekel, MD
CONTACTDoron Kabiri, MD, MPH
Outcome results
None listed