Comparing skin glue and sutures for repairing perineal tears after vaginal delivery
Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial
This study is testing whether using skin glue instead of stitches can help reduce pain for women who have perineal tears after vaginal delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | HaEmek Medical Center, Israel Academic / other |
| Locations | 1 site (Afula) |
| Trial ID | NCT03983343 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of adhesive glue versus fast-absorbable running sutures in reducing pain sensation following the repair of perineal tears (grade 1 and 2) or episiotomies during vaginal delivery. Women aged 18-45 who experience these types of tears will be randomly assigned to one of two groups: one receiving sutures and the other receiving adhesive glue for skin closure. The study will measure pain levels using a visual analogue scale within two hours post-procedure to determine which method results in less pain. The trial is conducted at Emek Medical Center in Israel.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 who have experienced a grade 1 or 2 perineal tear or episiotomy during vaginal delivery.
Not a fit: Patients with severe perineal tears (grades 3 or 4), operative vaginal deliveries, or significant underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less painful and more efficient method for repairing perineal tears, improving recovery for new mothers.
How similar studies have performed: While the use of adhesive glue for skin closure is gaining interest, this specific comparison with running sutures is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women aged 18-45. 2. Term birth (\> 37.0 weeks). 3. Perineal tears grade 1 or 2, or episiotomy. Exclusion Criteria: 1. Perineal tears grades 3 or 4. 2. Operative vaginal deliveries. 3. Significant background diseases that can affect pain or recovery time: Pregestational diabetes mellitus, any heart disease, severe pulmonary disease, collagen or connective tissue disease, rheumatic diseases, autoimmune diseases, known immunodeficiency and chronic steroid use. 4. Signs of local infection prior to the beginning of repair of the tear. 5. Known allergy to exofin®. 6. Pregestational body mass index \> 35 kg/m2. 7. Women with excessive bleeding that does not allow the use of glue. 8. Delivery of a dead fetus.
Where this trial is running
Afula
- EMEK Medical center — Afula, Israel (Recruiting)
Study contacts
- Study coordinator: Nitzan Sela, MD
- Email: nitzanse@clalit.org.il
- Phone: +972528244803
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.