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Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

Not Applicable
Completed
Conditions
Mediolateral Episiotomy After Delivery
Registration Number
NCT00840788
Lead Sponsor
Hospital Sao Joao
Brief Summary

Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
100
Inclusion Criteria
  • vaginal delivery
  • episiotomy performed
  • no further perineal or vaginal lesions present
Exclusion Criteria
  • previously existing local infections or lesions
  • body mass index > 35 (Kg/m2)
  • severe pulmonary disease
  • collagen disease
  • known immunodeficiency
  • diabetes mellitus
  • immunosuppressive treatment

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Self-assessed perineal painFirst 30 days after delivery
Secondary Outcome Measures
NameTimeMethod
Total time spent with repair of episiotomywithin 1 hour after birth
Pain during procedurewithin 1 hour after birth
Difficulties reported during procedurewithin 1 hour after birth
Number of sutures and adhesive devices usedwithin 1 hour after birth
Wound complications42-68 hours after delivery
Need to seek health facilities30 days after delivery
Return of sexual activity30 days after delivery

Trial Locations

Locations (1)

Servico de Ginecologia e Obstetricia, Hospital de S, Joao

🇵🇹

Porto, Portugal

Servico de Ginecologia e Obstetricia, Hospital de S, Joao
🇵🇹Porto, Portugal

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