Biologic Glue for First Degree Perineal Tears - Full Text View

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00746707

Purpose

biologic glue is superior to traditional suturing for first degree perineal tears

Condition	Intervention
Perineal Tear Grade 1 After Vaginal Delivery	Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate Device: 2. Histoacryl n-Butyl-2 Cyanoacrylate Procedure: 3. traditional suturing with vicryl rapid 2X0

Drug Information available for: Enbucrilate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

functional and cosmetic evaluation of perineal tear area. [ Time Frame: six weeks after birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pain scale assessment [ Time Frame: six weeks after birth ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental use of Dermabond for perineal tear grade 1 in 50 women	Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate adhesive of perineal tears
3: Active Comparator use of traditional suturing for perineal tear grade 1 in 50 women	Procedure: 3. traditional suturing with vicryl rapid 2X0 suturing of perineal tears grade one with vicryl rapid 2X0
2: Experimental use of Histoacryl for perineal tear grade 1 in 50 women	Device: 2. Histoacryl n-Butyl-2 Cyanoacrylate adhesive for perineal tears grade 2

Detailed Description:

the use of two types of skin adhesive will be compared to traditional suturing for first degree perineal tears

Eligibility

Criteria

Inclusion Criteria:

women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746707

Contacts

Contact: Tomer Feigenberg, MD

Locations

Israel
Hadassah Medical Organization	Recruiting
jerusalem, Israel, 91120
Contact: Tomer Feigenberg, M.D 9728508573316 feigenberg@013.net
Principal Investigator: Tomer Feigenberg, M.D
Sub-Investigator: Yosef ezra, M.D.
Sub-Investigator: Hen Y Sela, M.D.
Sub-Investigator: David Mankuta, M.D
Sub-Investigator: Asaf Ben-Meir, M.D

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Study Director:

yosef ezra, M.D.

hadassha medical organization, jerusalem israel

More Information

Responsible Party:	Hadassah Medical Organization ( tomer feigenberg/principal investigator )
Study ID Numbers:	feigenberg HMO-CTIL
Study First Received:	September 3, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00746707
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

skin adhesive, perineal tear, suture

Study placed in the following topic categories:

Lacerations

ClinicalTrials.gov processed this record on January 14, 2009