Clinical trial NCT03983343: Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial
Official title: Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perineal Tear
Keywords: Adhesive glue
Episiotomy
Pain sensation
Perineal tears
Running sutures
Skin closure
Visual Analogue Scale
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: Holy Family Hospital, Nazareth, Israel
First posted: 2019-06-12
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be asked to participate in this trial before perineal tear repair.

The patients will be randomly assigned to one of the two groups in a 1:1 ratio:

1. Suturing the perineal skin of the perineum using fast-absorbable running sutures (Vicryl Rapide 3-0)
2. Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate). Other than skin closure, both groups will be treated similarly according to standard protocol used for perineal tear repair. In both groups, the walls of the vagina, the perineal muscles and the subcutaneous tissue will be repaired and approximated using the standard method, i.e. with running sutures using Vicryl Rapid Stitch 2-0.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Trial design: Randomized controlled trial.

Objectives: To examine the effect of adhesive glue compared to fast-absorbable running sutures on pain sensation following repairing perineal skin in cases of tears grade 1 and 2.

Trial population: Women delivering vaginally at Emek Medical Center, and experience a spontaneous perineal tear, grade 1 or 2, or episiotomy.

Trial course:

Eligible patients will be asked to participate in this trial before perineal tear repair. Following providing an explanation about the trial, patients will be asked to provide written informed consent to participate in the trial.

The patients will be randomly assigned to one of the two groups in a 1:1 ratio:

1. Suturing the perineal skin of the perineum using fast-absorbable running sutures (Vicryl Rapide 3-0)
2. Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate). Other than skin closure, both groups will be treated similarly according to standard protocol used for perineal tear repair.

Sample size In order to detect a reduction of 20% in the VAS (visual analogue pain score) within 2 hours of the procedure between the groups \[from 40% to 20% in the running sutures and glue groups, respectively) with a level of significance of 95% (α = 0.05 - two tailed) and a power of 80% (β = 0.2) a sample size of 182 women (91 per group) is needed.

Data collected during the study:

* Data collected during the repair of the tear: maternal age, ethnicity, pre-gestational body mass index, background medical conditions, medication use, smoking status, birth's number, number of vaginal/caesarean births in the past, perineal tears in the past, antenatal complications, gestational age at delivery, epidural use during labor, birth weight, gender, grade of tear, spontaneous or episiotomy, cross over (failure of completing the procedure with the assigned method), number of skin sutures/glue capsules that was used, length of the perineal incision, repair time, use of local analgesics during repair, pain sensation related to the procedure. Pain sensation will be evaluated within 2 hours using a 0 (no pain) to 100 Visual Analogue Scale (VAS). Additionally immediate breastfeeding will be assessed as well.
* Data collected 48 hours after the repair and prior to discharge: pain level during walking/standing/sitting/lying down, (pain will be evaluated using the same VAS), discomfort during walking/standing/sitting/lying down, difficulty and pain in urination, local edema, local infection, separation of the edges of the wound, need for re-suturing, need to remove a stitch, woman's satisfaction and breastfeeding.
* Data collected 4-6 weeks after repair: women will be asked to return for check-up visit by a physician that was not involved in the repair and unaware of the allocation group. The outcomes that will be assessed at this visit will include: pain during walking/standing/sitting/lying, discomfort during walking/standing/sitting/lying down, difficulty and pain in urination, time to return to sexual activity, dyspareunia, cosmetic result, skin dehiscence and granuloma, preference of women for the next delivery. A telephone questionnaire will be used to collect the same data among women who do not attend the clinic visit within 6 weeks.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: within 2 hours after completing the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: EMEK Medical center
Study officials:
affiliation: Emek Medical Center, Afula, Israel
name: Raed Salim, MD
role: STUDY_CHAIR
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