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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Foundation for Southwest Orthopedic Research
Houston, Texas, United States
Primary Outcome Measure
The primary endpoint is the mean procedure time improvement for TKA incision closure using a combined suture/adhesive or suture/staple approach versus suture closure alone.
Time frame: 1/2009-10/2009
Mean postop hospital stay
Change in mean postop hospital stay between study and control cohorts
Time frame: 1/2009-10/2009
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