Novosyn® Quick in Patients Undergoing Episiotomy Closure
- Conditions
- Episiotomy Wound
- Registration Number
- NCT05233527
- Lead Sponsor
- Aesculap AG
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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
- No exclusion criteria have been set
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound dehiscence rate up to 1 month postpartum A dehiscence of the wound which needs surgical treatment with re-closure.
- Secondary Outcome Measures
Name Time Method Rectovaginal fistula up to 1 month postpartum Incidence of Rectovaginal fistula after Episiotomy closure
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".
Rate of Re-suturing up to 1 month postpartum Number of patients requiring a re-suturing due to wound dehiscence
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).
Abscess formation up to 1 month postpartum Incidence of Abscess formation after Episiotomy closure
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
Hematoma up to 1 month postpartum Incidence of Hematoma 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".
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)
Bleeding up to 1 month postpartum Incidence of Bleeding after Episiotomy closure
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
Trial Locations
- Locations (1)
IDC Hospital General de Catalunya
🇪🇸Sant Cugat Del Vallès, Catalunya, Spain