An interventional study of Antibacterial Vicryl Plus 2/0 and Standard Vicryl 2/0 in Suture Materials, sponsored by ASST Fatebenefratelli Sacco. Active, not recruiting at 1 site in Italy. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by ASST Fatebenefratelli Sacco · Not applicable, Interventional, and Other
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:
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.
ASST Fatebenefratelli Sacco is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
antibacterial Vicryl Plus 2/0 sutures.
Device: Antibacterial Vicryl Plus 2/0
standard (non-antibacterial) Vicryl 2/0 sutures.
Device: Standard Vicryl 2/0
antibacterial Vicryl Plus 2/0 sutures are multifilament absorbable synthetic sutures that are coated with triclosan, a purified antimicrobial.
Vicryl rapid coated 2/0 sutures are multifilament absorbable synthetic sutures not treated with any antimicrobial.
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)
Time frame: 48 hours, 40 days and six months postpartum.
Re-suturing
Re-suturing (performed or not performed)
Time frame: at 48 hours and 40 days after delivery
Wound Healing Status Assessed by ASEPSIS Score
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.
Time frame: 48 hours, 40 days and six months postpartum.
Functional disorders secondary to episiotomy repair
Assessment of dyspareunia (present or absent), urinary disorders (present or absent) ,and bowel disorders (present or absent)
Time frame: Assessed at 6 months postpartum
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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ASST Fatebenefratelli Sacco