Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

Mediolateral Episiotomy After Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840788
• Other study ID #: Episio- 01 - RCT
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: February 9, 2009
• Start date: May 2005
• Est. completion date: January 2007

Study information

• Verified date: February 2009
• Source: Hospital Sao Joao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mediolateral Episiotomy After Delivery

Intervention

Procedure:
• octyl-2-cyanoacrylate adhesive glue
use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy
• Subcuticular suture of perineal skin
Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair

Locations

Country	Name	City	State
Portugal	Servico de Ginecologia e Obstetricia, Hospital de S, Joao	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Sao Joao	Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-assessed perineal pain		First 30 days after delivery	No
Secondary	Total time spent with repair of episiotomy		within 1 hour after birth	No
Secondary	Pain during procedure		within 1 hour after birth	No
Secondary	Difficulties reported during procedure		within 1 hour after birth	Yes
Secondary	Number of sutures and adhesive devices used		within 1 hour after birth	No
Secondary	Wound complications		42-68 hours after delivery	Yes
Secondary	Need to seek health facilities		30 days after delivery	Yes
Secondary	Return of sexual activity		30 days after delivery	No