Perineal Tear Clinical Trial
Official title:
A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth
Verified date | June 2006 |
Source | Ethicon, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | January 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | McDonald Murrmann Women's Clinic | Memphis | Tennessee |
United States | Phoenix OB-GYN Associates | Moorestown | New Jersey |
United States | Tidewater Physicians for Women | Norfolk | Virginia |
United States | Virginia Beach Obstetrics & Gynecology | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
Ethicon, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth | |||
Primary | The incidence of perineal skin opening requiring re-closure post-partum | |||
Secondary | Presence and extent of clinically relevant skin openings | |||
Secondary | Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area | |||
Secondary | Perineal skin closure cosmesis | |||
Secondary | Patient satisfaction |
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