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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Erythema Drainage Bruising Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Insorb staples

Subcuticular Absorbable staples

Group Type EXPERIMENTAL

Insorb staples

Intervention Type DEVICE

absorbable staples required for wound closure

Control

Metal staple wound closure

Group Type ACTIVE_COMPARATOR

metal staples (Ethicon metal stapler)

Intervention Type DEVICE

wound closure with metal staples

Interventions

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Insorb staples

absorbable staples required for wound closure

Intervention Type DEVICE

metal staples (Ethicon metal stapler)

wound closure with metal staples

Intervention Type DEVICE

Other Intervention Names

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Insorb absorbable stapler GDW Ethicon metal stapler

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes