EpisiotomyEPINOQNCT02762357
PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
An observational study of Episiotomy, run by Aesculap AG at 2 sites in Spain.
Trial summary
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy
- What is being tested?
- Novosyn® Quick
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2016to 7 Jan 2020
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Primiparous women who require perineal repair due to an episiotomy after spontaneous vaginal delivery.
- Singleton birth between 37 and 42 weeks gestation
- Written informed consent
Who cannot join
- Age< 18 years
- Previous perineal surgery
- Instrumental vaginal deliveries
- Multiparous (at least 1 previous perineal delivery)
- Episiotomy involving the anal sphincter or the rectum
- Medical consumption that might adversely affect healing
- Women with active infection at the time of delivery
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital General de Granollers
Granollers, 08402
IDC Hospital General de Catalunya
Sant Cugat Del Vallés, 08190
About this study
Official title: Post-Marketing Clinical Follow-up (PMCF) Study to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material for Episiotomy . A Monocenter, Prospective, Observational Study.
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.
- Conditions
- Episiotomy
- Being tested
- Novosyn® Quick
- Keywords
- Novosyn Quick, Episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novosyn® QuickDevice
Episiotomy closure
| Study group | Role | What they receive |
|---|---|---|
| Novosyn® Quick | episiotomy closure using suture material Receives: Device: Novosyn® Quick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound dehiscence
A dehiscence of the skin which needs surgical treatment with re-closure.
Measured: 3 months postpartum
Secondary outcomes (8)
Incidence of Re-suturing
Re-suturing due to wound dehiscence
Measured: 3 months postpartum
Incidence of suture removal
Suture removal due to wound problems (infection, gaping wound, residual material requiring removal)
Measured: 3 months postpartum
Short-term perineal pain (VAS)
Measured: 24h to 48h, 10 days postpartum
Long term perineal pain (VAS)
Measured: 3 months postpartum
Pain in daily living (VAS)
Pain in repose, during walking, during sitting, when urinating, and when defecating
Measured: 24h and 10 days postpartum
Dyspareunia
Questionnaire
Measured: 3 months post-operatively
Sexual intercourse
Questionnaire
Measured: 3 months post-operatively
Patient satisfaction with the repair (VAS)
Measured: until 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startSep 2016
- Primary completion7 Oct 2019
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762357
- Sponsor's protocol ID
- AAG-O-H-1504
- Acronym
- EPINOQ
- Status last verified
- Jul 2020
- First submitted
- 3 May 2016
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Follow-up (PMCF) Study to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material for Episiotomy . A Monocenter, Prospective, Observational Study.
- ClinicalTrials.gov ID
- NCT02762357
- Acronym / sponsor ID
- EPINOQ / AAG-O-H-1504
- Conditions
- Episiotomy
- Keywords
- Novosyn Quick, Episiotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- Sep 2016 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 4 May 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.
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novosyn® Quick | – | Device: Novosyn® Quickepisiotomy closure using suture material |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (3 listed)
- Primiparous women who require perineal repair due to an episiotomy after spontaneous vaginal delivery.
- Singleton birth between 37 and 42 weeks gestation
- Written informed consent
Key exclusion criteria (7 listed)
- Age< 18 years
- Previous perineal surgery
- Instrumental vaginal deliveries
- Multiparous (at least 1 previous perineal delivery)
- Episiotomy involving the anal sphincter or the rectum
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 |
|---|---|---|
| Novosyn® QuickEpisiotomy closure | Device | Novosyn® Quick |
Primary outcome
Incidence of wound dehiscence
Time frame: 3 months postpartum
A dehiscence of the skin which needs surgical treatment with re-closure.
8 secondary outcomes
Incidence of Re-suturing
Time frame: 3 months postpartum
Incidence of suture removal
Time frame: 3 months postpartum
Short-term perineal pain (VAS)
Time frame: 24h to 48h, 10 days postpartum
Long term perineal pain (VAS)
Time frame: 3 months postpartum
Pain in daily living (VAS)
Time frame: 24h and 10 days postpartum
Dyspareunia
Time frame: 3 months post-operatively
Sexual intercourse
Time frame: 3 months post-operatively
Patient satisfaction with the repair (VAS)
Time frame: until 3 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Episiotomy
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Pudendal Nerve Block for Pain Relief During Episiotomy Repair: A Randomized Controlled Trial
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy
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Repeated Pudendal Nerve Block and Physiotherapy for Prevention of Chronic Post-Episiotomy Pain
Chronic Post-episiotomy Pain, Postpartum Dyspareunia
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Effect of Mosaic Art on Episiotomy Repair Skills, Anxiety, and Learning Attitudes in Midwifery Students
Education, Nursing
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Episiotomy, run by Aesculap AG at 2 sites in Spain.
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 7 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: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of wound dehiscence (time frame: 3 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 9 Jul 2020.