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NCT Number: NCT07045285

Prospective Randomized Trial On Episiorrhaphy

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.

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Key information

Conditions

Suture Materials

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale dei Bambini "Vittore Buzzi"

Milan, Milano, 20154, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard Vicryl 2/0

Device

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

Primary outcomes

  1. Pain evaluation

    Time frame: 48 hours, 40 days and six months postpartum.

    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)

Secondary outcomes

  1. Re-suturing

    Time frame: at 48 hours and 40 days after delivery

    Re-suturing (performed or not performed)

  2. Wound Healing Status Assessed by ASEPSIS Score

    Time frame: 48 hours, 40 days and six months postpartum.

    The ASEPSIS (Additional treatment, Serous exudate, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay) score evaluates the extent of wound healing complications after delivery. It quantifies serous exudate, erythema, purulent exudate, and wound dehiscence on the suture line. Additional points are assigned for antibiotic use, drainage of purulent material, bacterial isolation from cultures, and hospitalization exceeding 14 days. Scores range from 0 to over 40, with higher scores indicating more severe wound infection or healing disturbance.

  3. Functional disorders secondary to episiotomy repair

    Time frame: Assessed at 6 months postpartum

    Assessment of dyspareunia (present or absent), urinary disorders (present or absent) ,and bowel disorders (present or absent)

Sponsors and collaborators

Lead sponsor

ASST Fatebenefratelli Sacco

Other

Registry information

Official study title

Prospective Randomized Trial Comparing Outcomes Of Episiorrhaphy Using Vicryl Rapid Coated 2/0 Versus Vicryl 2/0 Plus Triclosan

Acronym: VICRYL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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