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Clinical Trials/NCT00840788
NCT00840788
Completed
Not Applicable

Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.

Hospital Sao Joao1 site in 1 country100 target enrollmentMay 2005
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ConditionsMediolateral Episiotomy After Delivery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mediolateral Episiotomy After Delivery
Sponsor
Hospital Sao Joao
Enrollment
100
Locations
1
Primary Endpoint
Self-assessed perineal pain
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
January 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Self-assessed perineal pain

Time Frame: First 30 days after delivery

Secondary Outcomes

  • Pain during procedure(within 1 hour after birth)
  • Total time spent with repair of episiotomy(within 1 hour after birth)
  • Difficulties reported during procedure(within 1 hour after birth)
  • Number of sutures and adhesive devices used(within 1 hour after birth)
  • Wound complications(42-68 hours after delivery)
  • Need to seek health facilities(30 days after delivery)
  • Return of sexual activity(30 days after delivery)

Study Sites (1)

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