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

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

Interventions

DEVICE

VicrylPlus®

Suture

DEVICE

Vicryl®

Suture

Sponsors & Collaborators

• Region Skane

  lead OTHER

Principal Investigators

• Nana Wiberg, MD, PhD · Senior consultant, Dept of Gyn et Obst, SUS, Lund, Sweden.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2018-02-28

Completion

2020-02-29

Countries

• Sweden

Study Locations