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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01924403
Other study ID # 13-005083
Secondary ID
Status Completed
Phase N/A
First received August 14, 2013
Last updated February 13, 2015
Start date August 2013
Est. completion date July 2014

Study information

Verified date February 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 18 years old

- Primary diagnosis of osteoarthritis

- Surgical indication for index total knee arthroplasty

Exclusion Criteria:

- Previous surgery about the knee

- Systemic corticosteroid use

- Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Staple Closure

Vertical Mattress Closure

Running Subcuticular Closure


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perfusion of Wound Closure Surgical Point of Care Yes
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