Prospective Randomized Trial On Episiorrhaphy

NCT ID: NCT07045285

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

antibacterial sutures

antibacterial Vicryl Plus 2/0 sutures.

Group Type: EXPERIMENTAL

Antibacterial Vicryl Plus 2/0

Intervention Type: DEVICE

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

non-antibacterial sutures

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

Group Type: ACTIVE_COMPARATOR

Standard Vicryl 2/0

Intervention Type: DEVICE

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

Interventions

Antibacterial Vicryl Plus 2/0

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

Intervention Type: DEVICE

Standard Vicryl 2/0

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ASST Fatebenefratelli Sacco

OTHER

Sponsor Role: lead

Responsible Party

Valeria Maria Savasi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valeria Savasi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ASST Fatebenefratelli Sacco

Locations

Ospedale dei Bambini "Vittore Buzzi"

Milan, Milano, Italy

Countries

Italy

Other Identifiers

VICRYL

Identifier Type: -

Identifier Source: org_study_id