Novosyn® Quick in Patients Undergoing Episiotomy Closure

Episiotomy Wound Clinical Trial

— RETRO-EPINOQ  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05233527
• Other study ID #: AAG-O-H-2111
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Aesculap AG
• Contact: Aina Fernández Rodríguez
• Phone: +34935866200
• Email: info[@]bbraun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Episiotomy Wound

Intervention

Procedure:
• Episiotomy Closure
indicated episiotomy with Novosyn® Quick after spontaneous vaginal delivery

Locations

Country	Name	City	State
Spain	IDC Hospital General de Catalunya	Sant Cugat Del Vallès	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound dehiscence rate	A dehiscence of the wound which needs surgical treatment with re-closure.	up to 1 month postpartum
Secondary	Rate of Re-suturing	Number of patients requiring a re-suturing due to wound dehiscence	up to 1 month postpartum
Secondary	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)	up to 1 month postpartum
Secondary	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).	up to 1 month postpartum
Secondary	Bleeding	Incidence of Bleeding after Episiotomy closure	up to 1 month postpartum
Secondary	Hematoma	Incidence of Hematoma after Episiotomy closure	up to 1 month postpartum
Secondary	Abscess formation	Incidence of Abscess formation after Episiotomy closure	up to 1 month postpartum
Secondary	Rectovaginal fistula	Incidence of Rectovaginal fistula after Episiotomy closure	up to 1 month postpartum
Secondary	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".	after 48 hours postpartum
Secondary	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".	up to 1 month postpartum
Secondary	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	24-48 hours postpartum
Secondary	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	up to 1 month postpartum