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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
118
Unnamed facility
Bessemer, Alabama, United States
Phoenix OB-GYN Associates
Moorestown, New Jersey, United States
McDonald Murrmann Women's Clinic
Memphis, Tennessee, United States
Tidewater Physicians for Women
Norfolk, Virginia, United States
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
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
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Virginia Beach Obstetrics & Gynecology
Virginia Beach, Virginia, United States