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

Not Applicable

Completed

• Conditions: Pain; Drainage; Erythema; Bruising
• Interventions: Device: Insorb staples; Device: metal staples (Ethicon metal stapler)

• Registration Number: NCT00940446
• Lead Sponsor: Orthopaedic Research Foundation

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Primary Completion: 2010-04-30
• Study Completion: 2010-04-30
• Results First Submitted: 2017-04-03
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-04
• Last Update Submitted: 2018-01-04
• Results First Posted: 2018-01-30
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insorb staples	Insorb staples	Subcuticular Absorbable staples
Control	metal staples (Ethicon metal stapler)	Metal staple wound closure

Primary Outcome Measures

Name	Time	Method
Participants With Incisional Drainage, Swelling or Gaps of Incision	Discharge from initial hospital stay (2-5 days post-op)	Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.

Secondary Outcome Measures

Name	Time	Method
Participants With Wound Complications - Hematoma	up to 6 weeks post-op	Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.

Trial Locations

Locations (1)

Indiana Orthopaedic Hospital; 🇺🇸 Indianapolis, Indiana, United States