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

NCT03983343 | Unknown DMC FDA Device

• 1 other identifier: 0039-19-EMC
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Tear

Keywords

Adhesive glue; Episiotomy; Pain sensation; Perineal tears; Running sutures; Skin closure; Visual Analogue Scale

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be measured by asking the woman to describe the pain related to the procedure using a 0 (no pain) to 100 VAS (intolerable pain)

  within 2 hours after completing the procedure

Study Arms (2)

control group

NO INTERVENTION

Standard technique: Suturing the perineal skin with fast-absorbable running sutures (Vicryl Rapide 3-0).

intervention group

ACTIVE COMPARATOR

Closing the perineal skin using adhesive glue- exofin® (Octyl-2-cyanoacrylate)

Device: exofin®

Interventions

exofin® DEVICE

Perineal skin will be closed by adhesive glue - exofin® (Octyl-2-cyanoacrylate).

intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45.
• Term birth (\> 37.0 weeks).
• Perineal tears grade 1 or 2, or episiotomy.

You may not qualify if:

• Perineal tears grades 3 or 4.
• Operative vaginal deliveries.
• 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.
• Signs of local infection prior to the beginning of repair of the tear.
• Known allergy to exofin®.
• Pregestational body mass index \> 35 kg/m2.
• Women with excessive bleeding that does not allow the use of glue.
• Delivery of a dead fetus.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Holy Family Hospital, Nazareth, Israel: collaborator

Study Sites (1)

EMEK Medical center

Afula, 1834111, Israel

RECRUITING

Related Publications (13)

• Smith LA, Price N, Simonite V, Burns EE. Incidence of and risk factors for perineal trauma: a prospective observational study. BMC Pregnancy Childbirth. 2013 Mar 7;13:59. doi: 10.1186/1471-2393-13-59.

  PMID: 23497085 BACKGROUND

• Vale de Castro Monteiro M, Pereira GM, Aguiar RA, Azevedo RL, Correia-Junior MD, Reis ZS. Risk factors for severe obstetric perineal lacerations. Int Urogynecol J. 2016 Jan;27(1):61-7. doi: 10.1007/s00192-015-2795-5. Epub 2015 Jul 30.

  PMID: 26224381 BACKGROUND

• Friedman AM, Ananth CV, Prendergast E, D'Alton ME, Wright JD. Variation in and factors associated with use of episiotomy. JAMA. 2015 Jan 13;313(2):197-9. doi: 10.1001/jama.2014.14774. No abstract available.

  PMID: 25585333 BACKGROUND

• Kalis V, Laine K, de Leeuw JW, Ismail KM, Tincello DG. Classification of episiotomy: towards a standardisation of terminology. BJOG. 2012 Apr;119(5):522-6. doi: 10.1111/j.1471-0528.2011.03268.x. Epub 2012 Feb 3.

  PMID: 22304364 BACKGROUND

• Leeman L, Rogers R, Borders N, Teaf D, Qualls C. The Effect of Perineal Lacerations on Pelvic Floor Function and Anatomy at 6 Months Postpartum in a Prospective Cohort of Nulliparous Women. Birth. 2016 Dec;43(4):293-302. doi: 10.1111/birt.12258. Epub 2016 Oct 31.

  PMID: 27797099 BACKGROUND

• Kettle C, Dowswell T, Ismail KM. Continuous and interrupted suturing techniques for repair of episiotomy or second-degree tears. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD000947. doi: 10.1002/14651858.CD000947.pub3.

  PMID: 23152204 BACKGROUND

• Feigenberg T, Maor-Sagie E, Zivi E, Abu-Dia M, Ben-Meir A, Sela HY, Ezra Y. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial. Biomed Res Int. 2014;2014:526590. doi: 10.1155/2014/526590. Epub 2014 Jun 26.

  PMID: 25089271 BACKGROUND

• Singer AJ, Thode HC Jr. A review of the literature on octylcyanoacrylate tissue adhesive. Am J Surg. 2004 Feb;187(2):238-48. doi: 10.1016/j.amjsurg.2003.11.017.

  PMID: 14769312 BACKGROUND

• Seijmonsbergen-Schermers AE, Sahami S, Lucas C, Jonge Ad. Nonsuturing or Skin Adhesives versus Suturing of the Perineal Skin After Childbirth: A Systematic Review. Birth. 2015 Jun;42(2):100-15. doi: 10.1111/birt.12166. Epub 2015 Apr 11.

  PMID: 25864727 BACKGROUND

• Mota R, Costa F, Amaral A, Oliveira F, Santos CC, Ayres-De-Campos D. Skin adhesive versus subcuticular suture for perineal skin repair after episiotomy--a randomized controlled trial. Acta Obstet Gynecol Scand. 2009;88(6):660-6. doi: 10.1080/00016340902883133.

  PMID: 19353332 BACKGROUND

• Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.

  PMID: 20596233 BACKGROUND

• Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 198: Prevention and Management of Obstetric Lacerations at Vaginal Delivery. Obstet Gynecol. 2018 Sep;132(3):e87-e102. doi: 10.1097/AOG.0000000000002841.

  PMID: 30134424 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 165: Prevention and Management of Obstetric Lacerations at Vaginal Delivery. Obstet Gynecol. 2016 Jul;128(1):e1-e15. doi: 10.1097/AOG.0000000000001523.

  PMID: 27333357 BACKGROUND

Study Officials

• Raed Salim, MD

  Emek Medical Center, Afula, Israel

  STUDY CHAIR

Central Study Contacts

Nitzan Sela, MD

CONTACT

+972528244803; nitzanse@clalit.org.il

Raed Salim, MD

CONTACT

salim_ra@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Cosmetic result will be assessed 4-6 weeks after the repair by a doctor who did not participate in tear suturing immediately after delivery, and is not aware to the repair method used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: October 1, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

IL (1)