Prospective Randomized Trial On Episiorrhaphy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Primary outcome measure(s)

• Pain evaluation — 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)

Trial sites (1)

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