NCT00940446

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Orthopaedic Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Erythema
• Drainage
• Bruising
• Pain

Interventions

Type	Name	Description
DEVICE	Insorb staples	absorbable staples required for wound closure
DEVICE	metal staples (Ethicon metal stapler)	wound closure with metal staples

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-04-30
• Completion: 2010-04-30
• First posted: 2009-07-16
• Last updated: 2018-01-30
• Results posted: 2018-01-30

Locations

1 site across 1 country: United States