A Comparative Study of Incision Closure Methods for Total Knee Replacement
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.
Total Knee Replacement Closure
Device: Histoacryl Tissue Adhesive
Device: Monocryl 4-0
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty|
- Primary Outcome Measure [ Time Frame: 1/2009-10/2009 ] [ Designated as safety issue: No ]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.
- Mean postop hospital stay [ Time Frame: 1/2009-10/2009 ] [ Designated as safety issue: No ]Change in mean postop hospital stay between study and control cohorts
|Study Start Date:||January 2009|
|Study Completion Date:||October 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Histoacryl Tissue Adhesive
Histoacryl Blue (HAB) Tissue Adhesive (n-butyl-2 cyanoacrylate; B. Braun Corp., Melsungen, Germany). Histocryl is a FDA-approved sterile liquid skin adhesive that has been utilized as a substitute for sutures for wound closure for approximately 40 years.
|Device: Histoacryl Tissue Adhesive|
Active Comparator: Dermabond
Dermabond High Viscosity Tissue Adhesive (2-ocytl cyanoacrylate; Ethicon, Somerville, NJ). Dermabond is also a FDA-approved liquid bonding agent that has been utilized for wound closure for approximately 10 years and proven as effective as sutures.
Active Comparator: Staples
Visistat 35W Stapler (Teleflex Corp, Limerick, PA). The FDA-approved Weck staple system with stainless steel staples has been proven over years of use and remains the standard accepted closure approach due to speed of insertion as well as removal.
Active Comparator: Running Subcuticular with Monocryl
Monocryl 4-0 Suture (Ethicon, Somerville, NJ). Monocryl is an FDA-approved absorbable, synthetic, suture indicated for soft tissue approximation.
|Device: Monocryl 4-0|