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A Comparative Study of Incision Closure Methods for Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01088074
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Foundation for Southwest Orthopedic Research

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.


Condition or disease Intervention/treatment Phase
Total Knee Replacement Closure Wound Closure Device: Histoacryl Tissue Adhesive Device: Dermabond Device: Staples Device: Monocryl 4-0 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty
Study Start Date : January 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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.
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.
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.
Device: Monocryl 4-0



Primary Outcome Measures :
  1. Primary Outcome Measure [ Time Frame: 1/2009-10/2009 ]
    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.


Secondary Outcome Measures :
  1. Mean postop hospital stay [ Time Frame: 1/2009-10/2009 ]
    Change in mean postop hospital stay between study and control cohorts



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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°.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088074


Locations
United States, Texas
Foundation for Southwest Orthopedic Research
Houston, Texas, United States, 77030
Sponsors and Collaborators
Foundation for Southwest Orthopedic Research

Responsible Party: Foundation for Southwest Orthopedic Research
ClinicalTrials.gov Identifier: NCT01088074     History of Changes
Other Study ID Numbers: IRB1108-0328
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by Foundation for Southwest Orthopedic Research:
Total Knee Replacement
Closure Methods