Bandgrip vs Traditional Sutures TJA

NCT ID: NCT05166642

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2024-01-31

Brief Summary

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bandgrip Micro-Anchor Skin Closure

Group Type: ACTIVE_COMPARATOR

Bandgrip Micro-Anchor Wound Closure

Intervention Type: DEVICE

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

Standard of Care wound closure

Standard Monocryl suture closure

Group Type: ACTIVE_COMPARATOR

Suture closure

Intervention Type: DEVICE

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

Interventions

Bandgrip Micro-Anchor Wound Closure

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

Intervention Type: DEVICE

Suture closure

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Innovation and Research Organization

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Orthopaedics

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

Bandgrip001

Identifier Type: -

Identifier Source: org_study_id