A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth

Ethicon

Status and phase: Completed; Phase 3

Conditions: Episiotomy; Perineal Tear

Treatments: Device: High Viscosity DERMABOND

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196508

200-04-001

Details and patient eligibility

About

This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is at least 18 years of age.
• Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery.
• Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary.
• Patient has signed the informed consent form.

Exclusion criteria

• Patient has peripheral vascular disease.
• Patient has insulin dependent diabetes mellitus.
• Patient has a blood clotting disorder that requires therapy.
• Patient has a personal or family history of keloid formation or hypertrophy.
• Patient has a known allergy to cyanoacrylates or formaldehyde.
• Patient has impaired wound healing by history. Patient is a chronic steroid user.