Suture MaterialsVICRYLNCT07045285
Prospective Randomized Trial On Episiorrhaphy
A study testing Antibacterial Vicryl Plus 2/0 and Standard Vicryl 2/0 in people with Suture Materials, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Suture Materials
- What is being tested?
- Antibacterial Vicryl Plus 2/0 and Standard Vicryl 2/0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial Comparing Outcomes Of Episiorrhaphy Using Vicryl Rapid Coated 2/0 Versus Vicryl 2/0 Plus Triclosan
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.
Read more
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
- Being tested
- Antibacterial Vicryl Plus 2/0, Standard Vicryl 2/0
- Keywords
- Episiotomy, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibacterial Vicryl Plus 2/0Device
antibacterial Vicryl Plus 2/0 sutures are multifilament absorbable synthetic sutures that are coated with triclosan, a purified antimicrobial.
Standard Vicryl 2/0Device
Vicryl rapid coated 2/0 sutures are multifilament absorbable synthetic sutures not treated with any antimicrobial.
| Study group | Role | What they receive |
|---|---|---|
| antibacterial sutures | Experimental | antibacterial Vicryl Plus 2/0 sutures. Receives: Device: Antibacterial Vicryl Plus 2/0 |
| non-antibacterial sutures | Active comparator | standard (non-antibacterial) Vicryl 2/0 sutures. Receives: Device: Standard Vicryl 2/0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 hours, 40 days and six months postpartum.
Secondary outcomes (3)
Re-suturing
Re-suturing (performed or not performed)
Measured: 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.
Measured: 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)
Measured: Assessed at 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jun 2025
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture MaterialsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Maria Savasi, ASST Fatebenefratelli Sacco
- Investigators
- Valeria Savasi, MD, PhD, Principal investigator, ASST Fatebenefratelli Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045285
- Sponsor's protocol ID
- VICRYL
- Acronym
- VICRYL
- Status last verified
- Jun 2025
- First submitted
- 2 May 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Outcomes Of Episiorrhaphy Using Vicryl Rapid Coated 2/0 Versus Vicryl 2/0 Plus Triclosan
- ClinicalTrials.gov ID
- NCT07045285
- Acronym / sponsor ID
- VICRYL / VICRYL
- Conditions
- Suture Materials
- Keywords
- Episiotomy, pregnancy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibacterial sutures | Experimental | Device: Antibacterial Vicryl Plus 2/0antibacterial Vicryl Plus 2/0 sutures. |
| non-antibacterial sutures | Active comparator | Device: Standard Vicryl 2/0standard (non-antibacterial) Vicryl 2/0 sutures. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibacterial Vicryl Plus 2/0antibacterial Vicryl Plus 2/0 sutures are multifilament absorbable synthetic sutures that are coated with triclosan, a purified antimicrobial. | Device | antibacterial sutures |
| Standard Vicryl 2/0Vicryl rapid coated 2/0 sutures are multifilament absorbable synthetic sutures not treated with any antimicrobial. | Device | non-antibacterial sutures |
Primary outcome
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)
3 secondary outcomes
Re-suturing
Time frame: at 48 hours and 40 days after delivery
Wound Healing Status Assessed by ASEPSIS Score
Time frame: 48 hours, 40 days and six months postpartum.
Functional disorders secondary to episiotomy repair
Time frame: Assessed at 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria Savasi, MD, PhD principal investigator
ASST Fatebenefratelli Sacco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibacterial Vicryl Plus 2/0 and Standard Vicryl 2/0 in people with Suture Materials, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evaluation (time frame: 48 hours, 40 days and six months postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.