Suture Versus Glue (Dermabond) Closure During Cesarean Delivery (SVGCS)

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Suture; Complications; Adhesive; Band

Treatments: Device: MODIFIED VICRYL PLUS; Device: DERMABOND GLUE

Study type: Interventional

Funder types: Other

Identifiers

NCT02831946

0062-16-MMC

Details and patient eligibility

About

To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

MODIFIED VICRYL PLUS

Experimental group

Description:

The intra-cuticular layer will closed with with VICRYL PLUS suture

Treatment:

Device: MODIFIED VICRYL PLUS

DERMABOND GLUE

Experimental group

Description:

The intra-cuticular layer will closed with with DERMABOND GLUE

Treatment:

Device: DERMABOND GLUE