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

March 16, 2010
August 21, 2012
January 2009
August 2009   (final data collection date for primary outcome measure)
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.
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
Complete list of historical versions of study NCT01088074 on ClinicalTrials.gov Archive Site
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
Mean postop hospital stay [ Designated as safety issue: No ]
Change in mean postop hospital stay between study and control cohorts
Not Provided
Not Provided
 
A Comparative Study of Incision Closure Methods for Total Knee Replacement
A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Total Knee Replacement Closure
  • Wound Closure
  • Device: Histoacryl Tissue Adhesive
  • Device: Dermabond
  • Device: Staples
  • Device: Monocryl 4-0
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
October 2009
August 2009   (final data collection date for primary outcome measure)

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°.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01088074
IRB1108-0328
Yes
Foundation for Southwest Orthopedic Research
Foundation for Southwest Orthopedic Research
Not Provided
Not Provided
Foundation for Southwest Orthopedic Research
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP