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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
  Purpose

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 Intervention
Total Knee Replacement Closure
Wound Closure
 Device: Histoacryl Tissue Adhesive
Device: Dermabond
Device: Staples
Device: Monocryl 4-0

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Foundation for Southwest Orthopedic Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 75
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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°.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088074

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

No publications provided

Responsible Party: Foundation for Southwest Orthopedic Research
ClinicalTrials.gov Identifier: NCT01088074     History of Changes
Other Study ID Numbers: IRB1108-0328
Study First Received: March 16, 2010
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013