Bandgrip vs Traditional Sutures TJA

Center for Innovation and Research Organization

Status: Suspended

Conditions: Osteoarthritis

Treatments: Device: Suture closure; Device: Bandgrip Micro-Anchor Wound Closure

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05166642

Bandgrip001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Bandgrip Micro-Anchor Skin Closure

Active Comparator group

Treatment:

Device: Bandgrip Micro-Anchor Wound Closure

Standard of Care wound closure

Active Comparator group

Description:

Standard Monocryl suture closure

Treatment:

Device: Suture closure