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Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

This study has been completed.
Sponsor:
Collaborator:
Faculdade de Medicina da Universidade do Porto
Information provided by:
Hospital Sao Joao
ClinicalTrials.gov Identifier:
NCT00840788
First received: February 9, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Mediolateral Episiotomy After Delivery
 Procedure: octyl-2-cyanoacrylate adhesive glue
Procedure: Subcuticular suture of perineal skin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.

Further study details as provided by Hospital Sao Joao:

Primary Outcome Measures:
  • Self-assessed perineal pain [ Time Frame: First 30 days after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total time spent with repair of episiotomy [ Time Frame: within 1 hour after birth ] [ Designated as safety issue: No ]
  • Pain during procedure [ Time Frame: within 1 hour after birth ] [ Designated as safety issue: No ]
  • Difficulties reported during procedure [ Time Frame: within 1 hour after birth ] [ Designated as safety issue: Yes ]
  • Number of sutures and adhesive devices used [ Time Frame: within 1 hour after birth ] [ Designated as safety issue: No ]
  • Wound complications [ Time Frame: 42-68 hours after delivery ] [ Designated as safety issue: Yes ]
  • Need to seek health facilities [ Time Frame: 30 days after delivery ] [ Designated as safety issue: Yes ]
  • Return of sexual activity [ Time Frame: 30 days after delivery ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2005
Study Completion Date: January 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Skin adhesive
perineal skin repair with octyl-2-cyanoacrylate skin adhesive
 Procedure: octyl-2-cyanoacrylate adhesive glue
use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy
Other Name: Dermabond
Active Comparator: subcuticular suture
continuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910
 Procedure: Subcuticular suture of perineal skin
Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair
Other Name: Vicryl

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840788

Locations
Portugal
Servico de Ginecologia e Obstetricia, Hospital de S, Joao
Porto, Portugal, 4200-319
Sponsors and Collaborators
Hospital Sao Joao
Faculdade de Medicina da Universidade do Porto
Investigators
Principal Investigator: Diogo Ayres-de-Campos, PhD Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto
  More Information

No publications provided

Responsible Party: Diogo Ayres de Campos, Servico de Ginecologia e Obstetricia, Hospital de S. Joao
ClinicalTrials.gov Identifier: NCT00840788     History of Changes
Other Study ID Numbers: Episio- 01 - RCT
Study First Received: February 9, 2009
Last Updated: February 9, 2009
Health Authority: Portugal: Health Ethic Committee

Keywords provided by Hospital Sao Joao:
skin adhesive
tissue adhesive
mediolateral episiotomy
 perineal repair
labor and delivery
repair

ClinicalTrials.gov processed this record on June 18, 2013