A Comparative Study of Incision Closure Methods for Total Knee Replacement

Foundation for Southwest Orthopedic Research

Status: Completed

Conditions: Wound Closure; Total Knee Replacement Closure

Treatments: Device: Dermabond; Device: Histoacryl Tissue Adhesive; Device: Monocryl 4-0; Device: Staples

Study type: Interventional

Funder types: Other

Identifiers

NCT01088074

IRB1108-0328

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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°.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 4 patient groups

Histoacryl Tissue Adhesive

Active Comparator group

Description:

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.

Treatment:

Device: Histoacryl Tissue Adhesive

Dermabond

Active Comparator group

Description:

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.

Treatment:

Device: Dermabond

Staples

Active Comparator group

Description:

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.

Treatment:

Device: Staples

Running Subcuticular with Monocryl

Active Comparator group

Description:

Monocryl 4-0 Suture (Ethicon, Somerville, NJ). Monocryl is an FDA-approved absorbable, synthetic, suture indicated for soft tissue approximation.

Treatment:

Device: Monocryl 4-0