A Comparative Study of Incision Closure Methods for Total Knee Replacement

Not Applicable

Completed

• Conditions: Total Knee Replacement Closure; Wound Closure
• Interventions: Device: Dermabond; Device: Histoacryl Tissue Adhesive; Device: Staples; Device: Monocryl 4-0

• Registration Number: NCT01088074
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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°.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dermabond	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.
Histoacryl Tissue Adhesive	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.
Staples	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.
Running Subcuticular with Monocryl	Monocryl 4-0	Monocryl 4-0 Suture (Ethicon, Somerville, NJ). Monocryl is an FDA-approved absorbable, synthetic, suture indicated for soft tissue approximation.

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	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

Name	Time	Method
Mean postop hospital stay	1/2009-10/2009	Change in mean postop hospital stay between study and control cohorts

Trial Locations

Locations (1)

Foundation for Southwest Orthopedic Research; 🇺🇸 Houston, Texas, United States