Prospective Randomized Trial On Episiorrhaphy

NCT07045285 | Active Not Recruiting

• 1 other identifier: VICRYL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

An episiotomy refers to the incision of the perineum performed to increase the space of the vaginal opening to facilitate the birth of the newborn. Subsequently, the incision is closed by aligning the tissues without cutaneous and vascular alterations. Although a systematic review and metanalysis demonstrated that sutures coated with triclosan, a purified antimicrobial, prevent surgical site infections, there is no evidence in the literature regarding the use of antibacterial sutures for perineal plane compared to standard ones. Therefore, the goal of this clinical trial is to compare the outcomes of incisions performed with standard Vicryl 2/0 sutures and antibacterial Vicryl Plus 2/0 sutures. The study involves women giving birth at the Vittore Buzzi Children's Hospital, for whom an incision is necessary at the time of delivery. Participants will be evaluated at 48 hours (at the time of the hospital discharge visit), 40 days (at the postpartum visit), and 6 months (by phone interview) after delivery. In particular, the aim of this study is to assess whether:

• antibacterial Vicryl Plus 2/0 sutures reduce pain after delivery;
• antibacterial Vicryl Plus 2/0 sutures improve the overall wound healing rate, avoid sexual, urinary or bowel disorders and the need for additional pharmacological, surgical, or physiotherapeutic interventions (in case of suboptimal wound healing). This study also aims to validate a new ASEPSIS ( Additional Treatment, Serous exudate, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria and Stay) score for the evaluation of healing outcomes of episiotomies. This is a double-blind, parallel-group randomized controlled trial. After obtaining informed consent, participants are randomly assigned either to the experimental group or the control group. Participants do not know the group they belong to, as the researchers; only the healthcare professional performing the suture knows it.

Conditions

Suture Materials

Keywords

Episiotomy; pregnancy

Outcome Measures

Primary Outcomes (1)

• Pain evaluation

  Pain is defined through a Swab test (based on a pain scale known as the Visual Analogue scale (VAS) with a score from 0 to 10 (0= no pain, 10=worst imaginable pain)

  48 hours, 40 days and six months postpartum.

Secondary Outcomes (3)

• Re-suturing

  at 48 hours and 40 days after delivery

• Wound Healing Status Assessed by ASEPSIS Score

  48 hours, 40 days and six months postpartum.

• Functional disorders secondary to episiotomy repair

  Assessed at 6 months postpartum

Study Arms (2)

antibacterial sutures

EXPERIMENTAL

antibacterial Vicryl Plus 2/0 sutures.

Device: Antibacterial Vicryl Plus 2/0

non-antibacterial sutures

ACTIVE COMPARATOR

standard (non-antibacterial) Vicryl 2/0 sutures.

Device: Standard Vicryl 2/0

Interventions

Antibacterial Vicryl Plus 2/0 DEVICE

antibacterial Vicryl Plus 2/0 sutures are multifilament absorbable synthetic sutures that are coated with triclosan, a purified antimicrobial.

antibacterial sutures

Standard Vicryl 2/0 DEVICE

Vicryl rapid coated 2/0 sutures are multifilament absorbable synthetic sutures not treated with any antimicrobial.

non-antibacterial sutures

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women at term (more than 37 weeks);
• age between 18 and 40 years;
• women who give consent to participate in the study;
• women who give birth during the recruitment period;
• women for whom an episiotomy is necessary at the time of delivery.

You may not qualify if:

• age lower than 18 years and more than 40 years;
• gestational age lower than 37 weeks;
• diabetes mellitus or gestational diabetes;
• African and South-East Asian ethnicities;
• cigarette smoking;
• BMI higher than 30;
• anemia;
• lack of consent to participate;
• complicated episiotomy and/or presence of other spontaneous perineal lacerations;
• women lost to follow-up or who have undergone non-gynecological perineal interventions during the follow-up period.

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (1)

Ospedale dei Bambini "Vittore Buzzi"

Milan, Milano, 20154, Italy

Location

Study Officials

• Valeria Savasi, MD, PhD

  ASST Fatebenefratelli Sacco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: July 1, 2025
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)