The PLUS Study: Comparison of VicrylPlus® Versus Vicryl® for Repair of Perineal Tears

NCT02863874 | Completed

• 1 other identifier: 2015/774
• Study Type: interventional
• Target: 1,890
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION It is estimated that over 80% of women who give vaginal birth will sustain some form of perineal tear and of these 60-70% will require suturing. It is of great importance that operators are familiar with the best suturing technique and suture material in order to minimize possible associated short- and long-term sequelae. There is evidence for suturing continuously to reduce postoperative pain and superficial dyspareunia, but the choice of suture-material is still debated. The function of a suture is to close the wound to minimize the bleeding, the risk for infection and to adapt the wound edges to promote anatomic correct healing. Infection results in softened wound edges, shirked sutures, pain and dehiscence. Delayed and/or compromised wound healing is correlated with impaired strength in the affected tissue. Reported frequency of infection after first and second degree tear is between 1 and 11% where the discrepancy most likely is due to poor registration and follow-up. In 2004 Polyglactin 910 was launched with a new antibacterial coating of Triclosan (VicrylPlus®). Studies suggest a correlation between the use of VicrylPlus® and a reduction of up to 30% of surgical site infections (SSI) compared to conventional sutures in a non-colonized wound. OBJEKTIVE: The primary objective is to compare infection rates and pain intensity when using Vicryl® versus VicrylPlus® for perineal repair after delivery. Secondly, to show if there is a difference in sequelae (pelvic floor dysfunction) after one year between the two groups. METHODS The participants are randomly allocated to continuously suturing with either Vicryl® or VicrylPlus®. Sealed identical-looking envelopes are prepared and placed in the delivery room (randomized into blocks of 50) containing randomization number, sutures, declaration of informed consent and questionnaires. The participants are instructed to fill in the first questionnaire after 7 days and the second questionnaire after 8 weeks post partum. After 8 weeks all participants are offered a routine visit to the "out-patient clinic". After one year an internet-based survey will be sent out to the participants. In case of complains/signs of deficient healing after one year, the woman will be offered a clinical control. Data will be analyzed according to intention to treat and per-protocol".

Conditions

Skin Structures and Soft Tissue Infections; Wound Infection

Keywords

Perineal tear; Labor; Triclosan

Outcome Measures

Primary Outcomes (1)

• Incidence of wound infection in vaginal and perineal tears after suturing with normal braided suture (Vicryl®) versus antibacterial braided suture (VicrylPlus®).

  Presence of infection determined by a certified physician according to CDC's Criteria for Defining a Surgical Site Infection.

  4 weeks

Secondary Outcomes (3)

• Difference in self-reported pain after suturing vaginal and perineal tears with normal braided or antibacterial braided suture.

  8 weeks

• Number of patients who need or are resutured within one year after delivery for each suture

  one year after delivery

• Number of patients with superficial/deep dyspareunia or pelvic floor dysfunction one year after delivery for each suture

  one year after delivery

Study Arms (2)

Vicryl®

ACTIVE COMPARATOR

The vaginal or and perineal tear is sutured continuously with Vicryl®. The instruments for suturing and the bedcover are clean whereas the gloves are sterile.

Device: Vicryl®

VicrylPlus®

ACTIVE COMPARATOR

The vaginal or and perineal tear is sutured continuously with VicrylPlus®. The instruments for suturing and bedcover are clean whereas the gloves are sterile.

Device: VicrylPlus®

Interventions

VicrylPlus® DEVICE

Suture

VicrylPlus®

Vicryl® DEVICE

Suture

Vicryl®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vaginal delivery complicated by a spontaneously first, second or third degree tear with need of continuously suturing
• Woman with episiotomy
• Able to read and understand Swedish

You may not qualify if:

• Previously perineal surgery other than primary repair after delivery
• Birth of a stillborn infant
• HIV or active Hepatitis B/C infection
• Severe perineal warts or varicose veins
• The operator is uncomfortable with continuous suturing

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Gynecology and Obstetrics

Lund, Skåne County, 22185, Sweden

Location

Related Publications (11)

• Wang ZX, Jiang CP, Cao Y, Ding YT. Systematic review and meta-analysis of triclosan-coated sutures for the prevention of surgical-site infection. Br J Surg. 2013 Mar;100(4):465-73. doi: 10.1002/bjs.9062. Epub 2013 Jan 21.

  PMID: 23338685 BACKGROUND

• McCandlish R, Bowler U, van Asten H, Berridge G, Winter C, Sames L, Garcia J, Renfrew M, Elbourne D. A randomised controlled trial of care of the perineum during second stage of normal labour. Br J Obstet Gynaecol. 1998 Dec;105(12):1262-72. doi: 10.1111/j.1471-0528.1998.tb10004.x.

  PMID: 9883917 BACKGROUND

• Kettle C, Hills RK, Jones P, Darby L, Gray R, Johanson R. Continuous versus interrupted perineal repair with standard or rapidly absorbed sutures after spontaneous vaginal birth: a randomised controlled trial. Lancet. 2002 Jun 29;359(9325):2217-23. doi: 10.1016/S0140-6736(02)09312-1.

  PMID: 12103284 BACKGROUND

• Kettle C, Dowswell T, Ismail KM. Absorbable suture materials for primary repair of episiotomy and second degree tears. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD000006. doi: 10.1002/14651858.CD000006.pub2.

  PMID: 20556745 BACKGROUND

• Johnson A, Thakar R, Sultan AH. Obstetric perineal wound infection: is there underreporting? Br J Nurs. 2012 Mar 8-21;21(5):S28, S30, S32-5. doi: 10.12968/bjon.2012.21.Sup5.S28.

  PMID: 22489339 BACKGROUND

• Gartti-Jardim EC, de Souza AP, Carvalho AC, Pereira CC, Okamoto R, Magro Filho O. Comparative study of the healing process when using Vicryl(R), Vicryl Rapid(R), Vicryl Plus(R), and Monocryl(R) sutures in the rat dermal tissue. Oral Maxillofac Surg. 2013 Dec;17(4):293-8. doi: 10.1007/s10006-012-0380-3. Epub 2012 Dec 28.

  PMID: 23269361 BACKGROUND

• Ford HR, Jones P, Gaines B, Reblock K, Simpkins DL. Intraoperative handling and wound healing: controlled clinical trial comparing coated VICRYL plus antibacterial suture (coated polyglactin 910 suture with triclosan) with coated VICRYL suture (coated polyglactin 910 suture). Surg Infect (Larchmt). 2005 Fall;6(3):313-21. doi: 10.1089/sur.2005.6.313.

  PMID: 16201941 BACKGROUND

• Edmiston CE, Seabrook GR, Goheen MP, Krepel CJ, Johnson CP, Lewis BD, Brown KR, Towne JB. Bacterial adherence to surgical sutures: can antibacterial-coated sutures reduce the risk of microbial contamination? J Am Coll Surg. 2006 Oct;203(4):481-9. doi: 10.1016/j.jamcollsurg.2006.06.026. Epub 2006 Aug 22.

  PMID: 17000391 BACKGROUND

• Fernando R, Sultan AH, Kettle C, Thakar R, Radley S. Methods of repair for obstetric anal sphincter injury. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD002866. doi: 10.1002/14651858.CD002866.pub2.

  PMID: 16855993 BACKGROUND

• Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.

  PMID: 18538699 BACKGROUND

• Sonnichsen K, Isberg PE, Elers J, Zaigham M, Wiberg N. The PLUS study: efficacy of triclosan coated suture (VicrylPlus(R)) to reduce infection in primary suture of childbirth related perineal tears - a randomized controlled trial. Matern Health Neonatol Perinatol. 2025 May 5;11(1):13. doi: 10.1186/s40748-025-00211-0.

  PMID: 40320545 DERIVED

MeSH Terms

Conditions

Soft Tissue Infections; Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Nana Wiberg, MD, PhD

  Senior consultant, Dept of Gyn et Obst, SUS, Lund, Sweden.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: August 11, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2020
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)