Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy
Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedFebruary 10, 2009
February 1, 2009
1 year
February 9, 2009
February 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-assessed perineal pain
First 30 days after delivery
Secondary Outcomes (7)
Total time spent with repair of episiotomy
within 1 hour after birth
Pain during procedure
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
- +2 more secondary outcomes
Study Arms (2)
Skin adhesive
EXPERIMENTALperineal skin repair with octyl-2-cyanoacrylate skin adhesive
subcuticular suture
ACTIVE COMPARATORcontinuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910
Interventions
use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy
Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair
Eligibility Criteria
You may qualify if:
- vaginal delivery
- episiotomy performed
- no further perineal or vaginal lesions present
You may not qualify if:
- previously existing local infections or lesions
- body mass index \> 35 (Kg/m2)
- severe pulmonary disease
- collagen disease
- known immunodeficiency
- diabetes mellitus
- immunosuppressive treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Sao Joaolead
- Universidade do Portocollaborator
Study Sites (1)
Servico de Ginecologia e Obstetricia, Hospital de S, Joao
Porto, Porto District, 4200-319, Portugal
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diogo Ayres-de-Campos, PhD
Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
May 1, 2005
Primary Completion
May 1, 2006
Study Completion
January 1, 2007
Last Updated
February 10, 2009
Record last verified: 2009-02