A Comparative Study of Incision Closure Methods for Total Knee Replacement

Wound Closure Clinical Trial

Official title:

A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088074
• Other study ID #: IRB1108-0328
• Status: Completed
• Phase: N/A
• First received: March 16, 2010
• Last updated: August 21, 2012
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2012
• Source: Foundation for Southwest Orthopedic Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Replacement Closure
• Wound Closure

Intervention

Device:
• Histoacryl Tissue Adhesive

• Dermabond

• Staples

• Monocryl 4-0

Locations

Country	Name	City	State
United States	Foundation for Southwest Orthopedic Research	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Southwest Orthopedic Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure	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.	1/2009-10/2009	No
Secondary	Mean postop hospital stay	Change in mean postop hospital stay between study and control cohorts	1/2009-10/2009	No