Clinical Trials Directory

Trials / Completed

CompletedNCT01088074

A Comparative Study of Incision Closure Methods for Total Knee Replacement

A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Foundation for Southwest Orthopedic Research · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Accepted

Summary

The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis. The hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). This is a prospective, randomized, controlled, single site, unblinded (open label) study.

Conditions

Interventions

TypeNameDescription
DEVICEHistoacryl Tissue Adhesive
DEVICEDermabond
DEVICEStaples
DEVICEMonocryl 4-0

Timeline

Start date
2009-01-01
Primary completion
2009-08-01
Completion
2009-10-01
First posted
2010-03-17
Last updated
2012-08-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01088074. Inclusion in this directory is not an endorsement.