The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.
Study Type
OBSERVATIONAL
Enrollment
46
Episiotomy closure
Hospital General de Granollers
Granollers, Spain
IDC Hospital General de Catalunya
Sant Cugat Del Vallés, Spain
Incidence of wound dehiscence
A dehiscence of the skin which needs surgical treatment with re-closure.
Time frame: 3 months postpartum
Incidence of Re-suturing
Re-suturing due to wound dehiscence
Time frame: 3 months postpartum
Incidence of suture removal
Suture removal due to wound problems (infection, gaping wound, residual material requiring removal)
Time frame: 3 months postpartum
Short-term perineal pain (VAS)
Time frame: 24h to 48h, 10 days postpartum
Long term perineal pain (VAS)
Time frame: 3 months postpartum
Pain in daily living (VAS)
Pain in repose, during walking, during sitting, when urinating, and when defecating
Time frame: 24h and 10 days postpartum
Dyspareunia
Questionnaire
Time frame: 3 months post-operatively
Sexual intercourse
Questionnaire
Time frame: 3 months post-operatively
Patient satisfaction with the repair (VAS)
Time frame: until 3 months postpartum
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