A Comparative Study of Incision Closure Methods for Total Knee Replacement

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty

Conditions
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Total Knee Replacement Closure, Wound Closure

Intervention / Treatment
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* Device: Histoacryl Tissue Adhesive
* Device: Dermabond
* Device: Staples
* Device: Monocryl 4-0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria included 18 years or older TKA scheduled without a bilateral planned within one week of the initial surgery Willingness to attend prescribed physical therapy 3 times per week. Exclusion Criteria: Exclusion criteria included medical conditions or personal circumstances that would prevent participation and completion of physical therapy and follow-up visits Current participation in another clinical trial Preoperative systemic infections Uncontrolled diabetes, or diseases or conditions known to effect the wound healing process Known hypersensitivity to cyanoacrylate Formaldehyde, or the dye D&C Violet #2 Prior knee hardware fixation devices Prior knee incisions greater than 9cm, and arthrofibrosis as evidence by limited ROM less than 80°.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Histoacryl Tissue Adhesive<br>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<br> <br> |
| Active Comparator: Dermabond<br>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. | Device: Dermabond<br> <br> |
| Active Comparator: Staples<br>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. | Device: Staples<br> <br> |
| Active Comparator: Running Subcuticular with Monocryl<br>Monocryl 4-0 Suture (Ethicon, Somerville, NJ). Monocryl is an FDA-approved absorbable, synthetic, suture indicated for soft tissue approximation. | Device: Monocryl 4-0<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1/2009-10/2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean postop hospital stay | Change in mean postop hospital stay between study and control cohorts | 1/2009-10/2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Closure Methods