Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial

Launched by HAEMEK MEDICAL CENTER, ISRAEL · Jun 10, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating whether using skin glue is a better option than traditional stitches for repairing minor perineal tears (grade 1 and 2) and episiotomies after vaginal delivery. The goal is to see if the glue method can speed up the healing process and reduce pain while still keeping the risk of complications, like infection or bleeding, similar to that of stitches.

Women aged 18 to 45 who have given birth at term (after 37 weeks) and have a minor perineal tear or episiotomy may be eligible to participate. Participants will have the chance to experience a potentially quicker and less painful repair method. It’s important to note that women with more severe perineal tears (grades 3 or 4), certain health issues, or signs of infection before repair will not be included in the trial. If you join, you will be contributing to valuable research that could help improve recovery for many women in the future.

Gender

FEMALE

Eligibility 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.