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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00940446
Other study ID # DAF_PC000001
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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