Completed

NCT Number: NCT00840788

Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

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.

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Key information

Conditions

Mediolateral Episiotomy After Delivery

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Servico de Ginecologia e Obstetricia, Hospital de S, Joao

Porto, Porto District, 4200-319, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

octyl-2-cyanoacrylate adhesive glue

Procedure

use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy

Other names: Dermabond

Subcuticular suture of perineal skin

Procedure

Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair

Other names: Vicryl

Primary outcomes

Self-assessed perineal pain

Time frame: First 30 days after delivery

Secondary outcomes

Total time spent with repair of episiotomy

Time frame: within 1 hour after birth
Pain during procedure

Time frame: within 1 hour after birth
Difficulties reported during procedure

Time frame: within 1 hour after birth
Number of sutures and adhesive devices used

Time frame: within 1 hour after birth
Wound complications

Time frame: 42-68 hours after delivery
Need to seek health facilities

Time frame: 30 days after delivery
Return of sexual activity

Time frame: 30 days after delivery

Sponsors and collaborators

Lead sponsor

Hospital Sao Joao

Other

Collaborators

Universidade do Porto

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2007
First posted: Feb 10, 2009
Registry last updated: Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.