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

Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The incidence of a perineal tears during labor is 70 to 90%, while in 96% of the cases it's a minor perineal tear (grade 1). In about 3% to 4% the perineal tear is major and involve the external (grade 3) and the internal anal sphincter (grade 4). Episiotomy, which is considered an iatrogenic grade 2 tear, is performed in about 12% of vaginal deliveries. Complications related to perineal tears include bleeding, the most common, that may lead to the development of vaginal or perineal hematoma. Additionally, local infection can develop and complicate the recovery from the injury. In rare cases, abscesses may occur and in rarer cases necrotizing fasciitis or recto-vaginal fistula may also evolve. The gold standard method for repairing perineal tears is to use absorbable (preferably fast-absorbing) sutures. Grade 1 tears that do not bleed and do not disrupt the anatomical structure of the perineum usually do not require repair. Grade 2 tears are usually sewn in a continuous absorbent suture and less in the form of single stitches. The use of adhesive glue to repair skin injuries began 20 years ago and the main adhesive used is dermabond® (Ethicon Inc. octyl-2-cyanoacrylate). The use of glue is faster and lead to less pain than the use of stitches or staples. It can be used for a variety of large or small, traumatic or iatrogenic wounds, with a cosmetic result, infection rate, and dehiscence rate similar to those achieved by stitches or staples. In light of this, the investigators intend to conduct a randomized trial that will examine the advantages and disadvantages of the use of glue compared to the traditional sutures for closure of the skin in perineal tears grade 1 and 2 and episiotomies after vaginal delivery. The investigators hypothesis is that the use of adhesive glue to close the skin in perineal tears grade 1 and 2 (including episiotomy), will be faster and associated with less pain compared to the traditional suturing method, without a significant difference in the rate of complications.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Women aged 18-45.

• Term birth (\> 37.0 weeks).

• Perineal tears grade 1 or 2, or episiotomy.

Locations
Other Locations
Israel
EMEK Medical center
RECRUITING
Afula
Contact Information
Primary
Nitzan Sela, MD
nitzanse@clalit.org.il
+972528244803
Backup
Raed Salim, MD
salim_ra@clalit.org.il
Time Frame
Start Date: 2019-10-01
Completion Date: 2024-08-01
Participants
Target number of participants: 182
Treatments
No_intervention: control group
Standard technique: Suturing the perineal skin with fast-absorbable running sutures (Vicryl Rapide 3-0).
Active_comparator: intervention group
Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate)
Related Therapeutic Areas
Sponsors
Leads: HaEmek Medical Center, Israel
Collaborators: Holy Family Hospital, Nazareth, Israel

This content was sourced from clinicaltrials.gov