Episiotomy, Perineal Tear
Conditions
Keywords
Childbirth
Brief summary
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.
Interventions
DEVICEHigh Viscosity DERMABOND
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth | — |
| The incidence of perineal skin opening requiring re-closure post-partum | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence and extent of clinically relevant skin openings | — |
| Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area | — |
| Perineal skin closure cosmesis | — |
| Patient satisfaction | — |
Countries
United States
Outcome results
None listed