Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples

University of Massachusetts, Worcester

Status: Terminated

Conditions: Cesarean Section

Treatments: Device: Dermabond; Device: Surgical skin staples

Study type: Interventional

Funder types: Other

Identifiers

NCT00524511

12462

Details and patient eligibility

About

Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.

Enrollment: 136 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women undergoing scheduled and non-scheduled cesarean deliveries

Exclusion criteria

• Prisoners
• Insulin-requiring diabetics
• Vertical skin incision
• Allergy to Dermabond

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

136 participants in 2 patient groups

1

Experimental group

Description:

Women receiving Dermabond for skin closure

Treatment:

Device: Surgical skin staples

2

Active Comparator group

Description:

Women receiving standard surgical skin staples

Treatment:

Device: Dermabond