Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

• Sponsor: Hospital Sao Joao (Other)
• Overall Status: Completed
• CT.gov ID: NCT00840788
• Collaborator: Universidade do Porto (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mediolateral Episiotomy After Delivery	Procedure: octyl-2-cyanoacrylate adhesive glue; Procedure: Subcuticular suture of perineal skin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Vicryl

Outcome Measures

Primary Outcome Measures

1. Self-assessed perineal pain [First 30 days after delivery]

Secondary Outcome Measures

1. Total time spent with repair of episiotomy [within 1 hour after birth]

2. Pain during procedure [within 1 hour after birth]

3. Difficulties reported during procedure [within 1 hour after birth]

4. Number of sutures and adhesive devices used [within 1 hour after birth]

5. Wound complications [42-68 hours after delivery]

6. Need to seek health facilities [30 days after delivery]

7. Return of sexual activity [30 days after delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Servico de Ginecologia e Obstetricia, Hospital de S, Joao	Porto		Portugal	4200-319

Sponsors and Collaborators

• Hospital Sao Joao
• Universidade do Porto

Investigators

• Principal Investigator: Diogo Ayres-de-Campos, PhD, Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00840788
• Other Study ID Numbers: Episio- 01 - RCT
• First Posted: Feb 10, 2009
• Last Update Posted: Feb 10, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: skin adhesive; tissue adhesive; mediolateral episiotomy; perineal repair; labor and delivery; repair

Study Results

No Results Posted as of Feb 10, 2009