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

Orthopaedic Research Foundation

Status: Completed

Conditions: Bruising; Erythema; Pain; Drainage

Treatments: Device: Insorb staples; Device: metal staples (Ethicon metal stapler)

Study type: Interventional

Funder types: Other

Identifiers

NCT00940446

DAF_PC000001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Insorb staples

Experimental group

Description:

Subcuticular Absorbable staples

Treatment:

Device: Insorb staples

Control

Active Comparator group

Description:

Metal staple wound closure

Treatment:

Device: metal staples (Ethicon metal stapler)