RETRO-EPINOQ: Novosyn® Quick in Patients Undergoing Episiotomy Closure
Study Details
Study Description
Brief Summary
Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Outcome Measures
Primary Outcome Measures
- Wound dehiscence rate [up to 1 month postpartum]
A dehiscence of the wound which needs surgical treatment with re-closure.
Secondary Outcome Measures
- Rate of Re-suturing [up to 1 month postpartum]
Number of patients requiring a re-suturing due to wound dehiscence
- Rate of Suture removal due to wound problems [up to 1 month postpartum]
Number of patients requiring suture removal due to wound problems (infection, gaping wound, residual material requiring removal)
- Surgical Site Infection rate [up to 1 month postpartum]
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).
- Bleeding [up to 1 month postpartum]
Incidence of Bleeding after Episiotomy closure
- Hematoma [up to 1 month postpartum]
Incidence of Hematoma after Episiotomy closure
- Abscess formation [up to 1 month postpartum]
Incidence of Abscess formation after Episiotomy closure
- Rectovaginal fistula [up to 1 month postpartum]
Incidence of Rectovaginal fistula after Episiotomy closure
- Short-term perineal pain (VAS) [after 48 hours postpartum]
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".
- Long-term perineal pain (VAS) [up to 1 month postpartum]
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".
- Short-term Pain in daily living (VAS) [24-48 hours postpartum]
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
- Long-term Pain in daily living (VAS) [up to 1 month postpartum]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- No exclusion criteria have been set
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IDC Hospital General de Catalunya | Sant Cugat Del Vallès | Catalunya | Spain | 08190 |
Sponsors and Collaborators
- Aesculap AG
- B.Braun Surgical SA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAG-O-H-2111