Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.
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 Type
OBSERVATIONAL
Enrollment
229
indicated episiotomy with Novosyn® Quick after spontaneous vaginal delivery
IDC Hospital General de Catalunya
Sant Cugat del Vallès, Catalonia, Spain
Wound dehiscence rate
A dehiscence of the wound which needs surgical treatment with re-closure.
Time frame: up to 1 month postpartum
Rate of Re-suturing
Number of patients requiring a re-suturing due to wound dehiscence
Time frame: 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)
Time frame: 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).
Time frame: up to 1 month postpartum
Bleeding
Incidence of Bleeding after Episiotomy closure
Time frame: up to 1 month postpartum
Hematoma
Incidence of Hematoma after Episiotomy closure
Time frame: up to 1 month postpartum
Abscess formation
Incidence of Abscess formation after Episiotomy closure
Time frame: up to 1 month postpartum
Rectovaginal fistula
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Incidence of Rectovaginal fistula after Episiotomy closure
Time frame: 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".
Time frame: 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".
Time frame: 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
Time frame: 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
Time frame: up to 1 month postpartum