NCT02831946

Suture Versus Glue (Dermabond) Closure During Cesarean Delivery

Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Adhesive; Band
• Suture; Complications

Interventions

Type	Name	Description
DEVICE	MODIFIED VICRYL PLUS	closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture
DEVICE	DERMABOND GLUE	closing the intra-cuticular layer with Dermabond glue

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• Completion: 2018-02-01
• First posted: 2016-07-13
• Last updated: 2016-07-13

Locations

1 site across 1 country: Israel