A Comparative Study of Incision Closure Methods for Total Knee Replacement

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Foundation for Southwest Orthopedic Research

ClinicalTrials.gov Identifier:

NCT01088074

First received: March 16, 2010

Last updated: August 21, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 16, 2010
Last Updated Date	August 21, 2012
Start Date ^ICMJE	January 2009
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 21, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: March 16, 2010)	Mean procedure time improvement [ 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
Change History	Complete list of historical versions of study NCT01088074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 21, 2012)	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
Original Secondary Outcome Measures ^ICMJE (submitted: March 16, 2010)	Mean postop hospital stay [ Designated as safety issue: No ] Change in mean postop hospital stay between study and control cohorts
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Comparative Study of Incision Closure Methods for Total Knee Replacement
Official Title ^ICMJE	A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Total Knee Replacement Closure Wound Closure
Intervention ^ICMJE	Device: Histoacryl Tissue Adhesive Device: Dermabond Device: Staples Device: Monocryl 4-0
Study Arm (s)	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. Intervention: 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. Intervention: Device: Dermabond 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. Intervention: Device: Staples 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. Intervention: Device: Monocryl 4-0
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	75
Completion Date	October 2009
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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°.
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01088074
Other Study ID Numbers ^ICMJE	IRB1108-0328
Has Data Monitoring Committee	Yes
Responsible Party	Foundation for Southwest Orthopedic Research
Study Sponsor ^ICMJE	Foundation for Southwest Orthopedic Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Foundation for Southwest Orthopedic Research
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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