Bandgrip vs Traditional Sutures TJA

Center for Innovation and Research Organization100 enrolled

Overview

Total Joint Arthroplasty (TJA) has become one of the most performed elective procedures. While the results of this procedure are often consistent with high patient satisfaction and return-to-function, wound-related complications can contribute to high-cost "bundle busters". Following surgery, wound drainage or other wound complications can lead to increased cost and decreased patient satisfaction. Secure wound closure is an important step in preventing wound-related complications. The surgical incision should be closed in a manner that prevents the wound edges from separating which could lead to possible drainage and bacterial contamination of the incision. Traditional incision closure following TJA includes sutures. These sutures are then removed in the office. BandGrip is a wound closure device that can be used to approximate skin edges of wounds from surgical incisions and traumatic lacerations. It is a bandage-type patch with several small skin anchors that are used to hold the skin edges together. The clear microanchors are 0.029 inches in height and do not puncture through the dermis. There is no need for medical removal as the patient can remove the bandage.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Osteoarthritis

Interventions

Bandgrip Micro-Anchor Wound ClosureDEVICE

This treatment group will utilize a suture closure technique for the deep dermal layers with Bandgrip being applied to the most superficial layer of the surgical incision

Suture closureDEVICE

This treatment gourd will utilize suture closure technique for all layers of the surgical incision.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is male or female greater than 18 years of age 2. Scheduled to undergo primary total knee or total hip replacement 3. Able to read and comprehend informed consent form and comply with the follow-up evaluation schedule Exclusion Criteria: 1. Prior surgical incision or scar in close proximity of the proposed incision (\<2 cm). 2. Local skin conditions such as dermatitis, eczema, or psoriasis. 3. Active or previous infection in the skin or the hip or knee to be operated. 4. Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use 5. Subject has a recent history of bleeding, coagulation and/or clotting disorders 6. Subject has a known allergy to BandGrip material (polycarbonate)

Outcomes

Primary Outcomes

Number of patients with wound healing complications

All wound-related complication following surgery

Time frame: From time of surgery to 30 days post-op

Secondary Outcomes

Closure time of surgical wound

Time (in seconds) that it takes to close the incisional wound during surgery

Time frame: Procedure (The time from the first skin pass with the suture needle until the time the last suture knot is tied will be recorded in seconds)