A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study

Columbia University

Status: Completed

Conditions: Cesarean Section; Wound; Complication

Treatments: Other: Suture; Device: Dermabond Prineo

Study type: Interventional

Funder types: Other

Identifiers

NCT05903547

AAAT9584

Details and patient eligibility

About

The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.

Full description

The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.

Enrollment: 151 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women age 18 years or older
• All women scheduled for primary or repeat cesarean deliveries
• All women undergoing intrapartum or antepartum cesarean delivery
• Pfannenstiel skin incision
• Birth of a live infant at time of cesarean delivery

Exclusion criteria

• Vertical skin incision
• Cesarean hysterectomy
• Emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of Chlorhexidine skin prep, vaginal prep, etc)
• Intrapartum stillbirth
• Planned postpartum follow up at another facility
• Contraindications to routine postpartum pain medications
• Adhesive or tape allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups, including a placebo group

Dermabond Prineo Group

Active Comparator group

Description:

At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.

Treatment:

Device: Dermabond Prineo

Suture Group

Placebo Comparator group

Description:

At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.

Treatment:

Other: Suture