- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088074
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Foundation for Southwest Orthopedic Research
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
|
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.
|
|
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.
|
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1/2009-10/2009
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean postop hospital stay
Time Frame: 1/2009-10/2009
|
Change in mean postop hospital stay between study and control cohorts
|
1/2009-10/2009
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB1108-0328
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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