Episiotomy WoundRETRO-EPINOQNCT05233527
Novosyn® Quick in Patients Undergoing Episiotomy Closure
An observational study of Episiotomy Wound, run by Aesculap AG at 1 site in Spain.
Trial summary
Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy Wound
- What is being tested?
- Episiotomy Closure
- Type of treatment
- Surgery or procedure
- How many people
- 229 participants
- Where
- 1 siteSpain
- Study dates
- 9 May 2024to Oct 2026
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.
Who may be able to join
- Women who underwent an indicated episiotomy between January 2020 - December 2020 at the Hospital General de Catalunya (Sant Cugat del Vallès, Spain) and received Novosyn® Quick
Who cannot join
- No exclusion criteria have been set
Trial locations and contacts
1 site in 1 country.
Spain1 site
IDC Hospital General de Catalunya
Sant Cugat del Vallès, Catalonia, 08190
About this study
Official title: Observational, Retrospective, Monocentric Clinical Study on the Safety of Novosyn® Quick in Women With a Spontaneous Vaginal Delivery Who Required an Indicated Episiotomy
Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.
Read the detailed description
The study design is a retrospective, consecutive series of women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.
All women treated with Novosyn® Quick between January 2020 - December 2020 at the Hospital General de Catalunya will be analyzed. The investigator team will access medical records for the cohort of patients identified.
- Conditions
- Episiotomy Wound
- Being tested
- Episiotomy Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episiotomy ClosureProcedure or surgery
indicated episiotomy with Novosyn® Quick after spontaneous vaginal delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound dehiscence rate
A dehiscence of the wound which needs surgical treatment with re-closure.
Measured: up to 1 month postpartum
Secondary outcomes (11)
Rate of Re-suturing
Number of patients requiring a re-suturing due to wound dehiscence
Measured: up to 1 month postpartum
Rate of Suture removal due to wound problems
Number of patients requiring suture removal due to wound problems (infection, gaping wound, residual material requiring removal)
Measured: up to 1 month postpartum
Surgical Site Infection rate
A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections can sometimes be superficial infections (A1) involving the skin only. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material (A2).
Measured: up to 1 month postpartum
Bleeding
Incidence of Bleeding after Episiotomy closure
Measured: up to 1 month postpartum
Hematoma
Incidence of Hematoma after Episiotomy closure
Measured: up to 1 month postpartum
Abscess formation
Incidence of Abscess formation after Episiotomy closure
Measured: up to 1 month postpartum
Rectovaginal fistula
Incidence of Rectovaginal fistula after Episiotomy closure
Measured: up to 1 month postpartum
Short-term perineal pain (VAS)
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".
Measured: after 48 hours postpartum
Long-term perineal pain (VAS)
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".
Measured: up to 1 month postpartum
Short-term Pain in daily living (VAS)
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".in repose, during walking, during sitting, when urinating, and when defecating
Measured: 24-48 hours postpartum
Long-term Pain in daily living (VAS)
This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".in repose, during walking, during sitting, when urinating, and when defecating
Measured: up to 1 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start9 May 2024
- Primary completion26 Mar 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy WoundStudies 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
- Retrospective
- Enrolment
- 229 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
- NCT05233527
- Sponsor's protocol ID
- AAG-O-H-2111
- Acronym
- RETRO-EPINOQ
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2022
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Retrospective, Monocentric Clinical Study on the Safety of Novosyn® Quick in Women With a Spontaneous Vaginal Delivery Who Required an Indicated Episiotomy
- ClinicalTrials.gov ID
- NCT05233527
- Acronym / sponsor ID
- RETRO-EPINOQ / AAG-O-H-2111
- Conditions
- Episiotomy Wound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 9 May 2024 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Feb 2022 (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.
Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.
Detailed description
The study design is a retrospective, consecutive series of women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.
All women treated with Novosyn® Quick between January 2020 - December 2020 at the Hospital General de Catalunya will be analyzed. The investigator team will access medical records for the cohort of patients identified.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.
Key inclusion criteria (1 listed)
- Women who underwent an indicated episiotomy between January 2020 - December 2020 at the Hospital General de Catalunya (Sant Cugat del Vallès, Spain) and received Novosyn® Quick
Key exclusion criteria (1 listed)
- No exclusion criteria have been set
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 |
|---|---|---|
| Episiotomy Closureindicated episiotomy with Novosyn® Quick after spontaneous vaginal delivery | Procedure or surgery | – |
Primary outcome
Wound dehiscence rate
Time frame: up to 1 month postpartum
A dehiscence of the wound which needs surgical treatment with re-closure.
11 secondary outcomes
Rate of Re-suturing
Time frame: up to 1 month postpartum
Rate of Suture removal due to wound problems
Time frame: up to 1 month postpartum
Surgical Site Infection rate
Time frame: up to 1 month postpartum
Bleeding
Time frame: up to 1 month postpartum
Hematoma
Time frame: up to 1 month postpartum
Abscess formation
Time frame: up to 1 month postpartum
Rectovaginal fistula
Time frame: up to 1 month postpartum
Short-term perineal pain (VAS)
Time frame: after 48 hours postpartum
Long-term perineal pain (VAS)
Time frame: up to 1 month postpartum
Short-term Pain in daily living (VAS)
Time frame: 24-48 hours postpartum
Long-term Pain in daily living (VAS)
Time frame: up to 1 month 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 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Episiotomy Wound
Not yet recruiting
Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women
Episiotomy, Platelet Rich Plasma (PRP)
Not yet recruiting
Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use
Episiotomy, Episiotomy Extended by Laceration
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Episiotomy Wound, run by Aesculap AG at 1 site 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 1 inclusion and 1 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 17 Apr 2026. 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 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?
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?
Wound dehiscence rate (time frame: up to 1 month 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 17 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.