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

A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth

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.

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.