EpisiotomyPhase 4EPISIOVICNCT02847936
Efficacy of Triclosan-coated Sutures in the Episiotomy
A Phase 4 study testing vicryl plus suture and vicryl suture in people with Episiotomy, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Episiotomy
- What is being tested?
- vicryl plus suture and vicryl suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTunisia
- Study dates
- Jul 2016to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women who had had an episiotomy at the delivery
- vaginal delivery
- no further perineal or vaginal lesions present
Who cannot join
- collagen disease
- known immunodeficiency
- Clinical signs of infection at the time of episiotomy
- History of keloids and a medical disorder that could affect wound healing
- Hypersensitivity to any of the suture materials used in the protocol
- Diabetes mellitus
- Disorders requiring chronic corticosteroid use or immunosuppression
- Instrumental extraction
Trial locations and contacts
1 site in 1 country.
AMIRA AYACHI, Ph d contact
Tunisia1 site, 1 recruiting
- Recruiting
University Hospital Bougatfa
Bizerte, 7000
AMIRA AYACHI, Ph D, 53660148 ext. 00216, benmrad.amira@yahoo.fr
About this study
Official title: The Effect of Triclosan-coated Sutures for Reducing Risk of Surgical Site Infection After Episiotomy: A Prospective Randomized Controlled Trial
Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery.
Read the detailed description
Women undergoing planned were randomized to either episiotomy suture with VICRYL PLUS or VICRYL. The primary outcome measures were number of sutures used and the development of hematoma, seroma, surgical site infection (SSI) or wound disruption one week after episiotomy. Secondary outcome measures were the cost of the treatment with or without infection, and scar evaluation (wound complication).
Data were analyzed according to the intention to treat principle.
- Conditions
- Episiotomy
- Being tested
- vicryl plus suture, vicryl suture
- Keywords
- triclosan, sutures, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vicryl plus sutureProcedure or surgery
episiotomy with triclosan-coated sutures
vicryl sutureProcedure or surgery
episiotomy with non antibacterial coated suture
| Study group | Role | What they receive |
|---|---|---|
| VICRYL PLUS | Active comparator | triclosan-coated sutures Receives: Procedure: vicryl plus suture |
| VICRYL | Active comparator | non antibacterial coated sutures Receives: Procedure: vicryl suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of sutures used
Measured: two hours
number of patients with wound complications (infection, hematoma, disruption)
Measured: one week
Secondary outcomes (2)
cost of the treatment with and without infection
cost of the treatment with and without infection
Measured: two weeks
number of patients with adverse outcomes
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpisiotomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ayachi, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847936
- Sponsor's protocol ID
- episio1
- Acronym
- EPISIOVIC
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guo J, Pan LH, Li YX, Yang XD, Li LQ, Zhang CY, Zhong JH. Efficacy of triclosan-coated sutures for reducing risk of surgical site infection in adults: a meta-analysis of randomized clinical trials. J Surg Res. 2016 Mar;201(1):105-17. doi: 10.1016/j.jss.2015.10.015. Epub 2015 Oct 23.
PubMed 26850191
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Triclosan-coated Sutures for Reducing Risk of Surgical Site Infection After Episiotomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02847936
- Acronym / sponsor ID
- EPISIOVIC / episio1
- Conditions
- Episiotomy
- Keywords
- triclosan, sutures, infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- 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.
Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery.
Detailed description
Women undergoing planned were randomized to either episiotomy suture with VICRYL PLUS or VICRYL. The primary outcome measures were number of sutures used and the development of hematoma, seroma, surgical site infection (SSI) or wound disruption one week after episiotomy. Secondary outcome measures were the cost of the treatment with or without infection, and scar evaluation (wound complication).
Data were analyzed according to the intention to treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VICRYL PLUS | Active comparator | Procedure: vicryl plus suturetriclosan-coated sutures |
| VICRYL | Active comparator | Procedure: vicryl suturenon antibacterial coated sutures |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women who had had an episiotomy at the delivery
- vaginal delivery
- no further perineal or vaginal lesions present
Key exclusion criteria (8 listed)
- collagen disease
- known immunodeficiency
- Clinical signs of infection at the time of episiotomy
- History of keloids and a medical disorder that could affect wound healing
- Hypersensitivity to any of the suture materials used in the protocol
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 |
|---|---|---|
| vicryl plus sutureepisiotomy with triclosan-coated sutures | Procedure or surgery | VICRYL PLUS |
| vicryl sutureepisiotomy with non antibacterial coated suture | Procedure or surgery | VICRYL |
Primary outcome
number of sutures used
Time frame: two hours
number of patients with wound complications (infection, hematoma, disruption)
Time frame: one week
2 secondary outcomes
cost of the treatment with and without infection
Time frame: two weeks
number of patients with adverse outcomes
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Results publication: PubMed 26850191Guo J, Pan LH, Li YX, Yang XD, Li LQ, Zhang CY, Zhong JH. Efficacy of triclosan-coated sutures for reducing risk of surgical site infection in adults: a meta-analysis of randomized clinical trials. J Surg Res. 2016 Mar;201(1):105-17. doi: 10.1016/j.jss.2015.10.015. Epub 2015 Oct 23.
- 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.
AMIRA AYACHI, Ph d contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vicryl plus suture and vicryl suture in people with Episiotomy, run by University Tunis El Manar at 1 site in Tunisia.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Jul 2016. 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 Tunisia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AMIRA AYACHI, Ph D (53660148 ext. 00216, benmrad.amira@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of sutures used (time frame: two hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02847936, which also lists 1 linked publication.
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 28 Jul 2016.