Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Adhesive; Band
- Sponsor
- Meir Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Patient and Observer Scar Assessment Scale (POSAS)
- Last Updated
- 9 years ago
Overview
Brief Summary
To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.
Detailed Description
Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months. Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption. Data were analyzed according to the intention to treat principle.
Investigators
Yair Daykan
MD
Meir Medical Center
Eligibility Criteria
Inclusion Criteria
- •Pregnant women between 18 and 45 years
- •Elective cesarian section
Exclusion Criteria
- •Clinical signs of infection at the time of CS
- •History of keloids and a medical disorder that could affect wound healing
- •Hypersensitivity to any of the suture materials used in the protocol
- •Diabetes mellitus
- •Disorders requiring chronic corticosteroid use or immunosuppression
Outcomes
Primary Outcomes
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 2 month
Subjective scar rating will be performed using the patient component of the POSAS. The POSAS Scale consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale
Secondary Outcomes
- post operative complication(1 month)