A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

This study has been completed.

Sponsor:

Collaborator:

OrthoIndy

Information provided by (Responsible Party):

Orthopaedic Research Foundation

ClinicalTrials.gov Identifier:

NCT00940446

First received: July 14, 2009

Last updated: November 8, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2009

Last Updated Date

November 8, 2012

Start Date ^ICMJE

July 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Appearance [ Time Frame: Dishcarge, 2 weeks & 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00940446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Photographs, CRF [ Time Frame: Discharge, 2 weeks & 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

Official Title ^ICMJE

A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement

Brief Summary

The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.

Detailed Description

Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Erythema
Drainage
Bruising
Pain

Intervention ^ICMJE

Device: Insorb staples
absorbable staples required for wound closure
Other Names:
- Insorb absorbable stapler
- GDW
Device: metal staples (Ethicon metal stapler)
wound closure with metal staples

Other Name: Ethicon metal stapler

Study Arm (s)

Experimental: Insorb staples
Subcuticular Absorbable staples

Intervention: Device: Insorb staples
Active Comparator: Control
Metal staple wound closure

Intervention: Device: metal staples (Ethicon metal stapler)

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

Completion Date

July 2009

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient is 18 years or older
Patient or legal representative is able to understand and provide signed consent for the procedure
Patient is willing and able to return for required follow-up visits
Patient needs a total hip arthroplasty surgical procedure

Exclusion Criteria:

Patient has an active infection
Patient is enrolled in another similar study
Patient has a known history of hepatitis
Patient has a known history of HIV
Patient has a known history of AIDs
Patient has a known history of IV drug abuse

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00940446

Other Study ID Numbers ^ICMJE

DAF_PC000001

Has Data Monitoring Committee

Yes

Responsible Party

Orthopaedic Research Foundation

Study Sponsor ^ICMJE

Orthopaedic Research Foundation

Collaborators ^ICMJE

OrthoIndy

Investigators ^ICMJE

Principal Investigator:

David A Fisher, MD

Indiana Orthopaedic Hospital

Information Provided By

Orthopaedic Research Foundation

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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