Novosyn® Quick in Patients Undergoing Episiotomy Closure

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

Detailed Description
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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.

Official Title
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Observational, Retrospective, Monocentric Clinical Study on the Safety of Novosyn® Quick in Women With a Spontaneous Vaginal Delivery Who Required an Indicated Episiotomy

Conditions
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Episiotomy Wound

Intervention / Treatment
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* Procedure: Episiotomy Closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Episiotomy Closure|indicated episiotomy with Novosyn® Quick after spontaneous vaginal delivery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound dehiscence rate | A dehiscence of the wound which needs surgical treatment with re-closure. | up to 1 month postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Re-suturing | Number of patients requiring a re-suturing due to wound dehiscence | 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) | 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). | up to 1 month postpartum | 
| Bleeding | Incidence of Bleeding after Episiotomy closure | up to 1 month postpartum | 
| Hematoma | Incidence of Hematoma after Episiotomy closure | up to 1 month postpartum | 
| Abscess formation | Incidence of Abscess formation after Episiotomy closure | up to 1 month postpartum | 
| Rectovaginal fistula | Incidence of Rectovaginal fistula after Episiotomy closure | 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. | 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. | 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 | 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 | up to 1 month postpartum |