A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth

This study has been completed.

Sponsor:

Information provided by:

Ethicon, Inc.

ClinicalTrials.gov Identifier:

NCT00196508

First received: September 13, 2005

Last updated: October 13, 2007

Last verified: June 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	September 13, 2005
Last Updated Date	October 13, 2007
Start Date ^ICMJE	April 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: April 24, 2006)	Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth The incidence of perineal skin opening requiring re-closure post-partum
Original Primary Outcome Measures ^ICMJE (submitted: September 13, 2005)	High Viscosity DERMABOND is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth. The incidence of perineal skin opening requiring re-closure up to 6 weeks post-partum.
Change History	Complete list of historical versions of study NCT00196508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 24, 2006)	Presence and extent of clinically relevant skin openings Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area Perineal skin closure cosmesis Patient satisfaction
Original Secondary Outcome Measures ^ICMJE (submitted: September 13, 2005)	Presence and extent of clinically relevant skin openings. Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area. Perineal skin closure cosmesis. Patient Satisfaction.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
Official Title ^ICMJE	A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth
Brief Summary	This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Episiotomy Perineal Tear
Intervention ^ICMJE	Device: High Viscosity DERMABOND
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	118
Completion Date	January 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient is at least 18 years of age. Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery. Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary. Patient has signed the informed consent form. Exclusion Criteria: Patient has peripheral vascular disease. Patient has insulin dependent diabetes mellitus. Patient has a blood clotting disorder that requires therapy. Patient has a personal or family history of keloid formation or hypertrophy. Patient has a known allergy to cyanoacrylates or formaldehyde. Patient has impaired wound healing by history. Patient is a chronic steroid user.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00196508
Other Study ID Numbers ^ICMJE	200-04-001
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Ethicon, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ethicon, Inc.
Verification Date	June 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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