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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940446
• Other study ID #: DAF_PC000001
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: January 4, 2018
• Start date: July 2007
• Est. completion date: April 30, 2010

Study information

• Verified date: January 2018
• Source: Orthopaedic Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2010
• Est. primary completion date: April 30, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bruising
• Drainage
• Erythema
• Pain

Intervention

Device:
• Insorb staples
absorbable staples required for wound closure
• metal staples (Ethicon metal stapler)
wound closure with metal staples

Locations

Country	Name	City	State
United States	Indiana Orthopaedic Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Orthopaedic Research Foundation	OrthoIndy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Incisional Drainage, Swelling or Gaps of Incision	Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.	Discharge from initial hospital stay (2-5 days post-op)
Secondary	Participants With Wound Complications - Hematoma	Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.	up to 6 weeks post-op