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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Histoacryl Tissue Adhesive | Active Comparator | 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. |
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| Dermabond | Active Comparator | 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. |
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| Staples | Active Comparator | 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. |
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| Running Subcuticular with Monocryl | Active Comparator | Monocryl 4-0 Suture (Ethicon, Somerville, NJ). Monocryl is an FDA-approved absorbable, synthetic, suture indicated for soft tissue approximation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Histoacryl Tissue Adhesive | Device |
| ||
| Dermabond |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean postop hospital stay | Change in mean postop hospital stay between study and control cohorts | 1/2009-10/2009 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Southwest Orthopedic Research | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Staples | Device |
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| Monocryl 4-0 | Device |
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