Bandgrip vs Traditional Sutures TJA

Not Applicable

Suspended

• Conditions: Osteoarthritis
• Interventions: Device: Suture closure; Device: Bandgrip Micro-Anchor Wound Closure

• Registration Number: NCT05166642
• Lead Sponsor: Center for Innovation and Research Organization

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-08
• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2021-12-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care wound closure	Suture closure	Standard Monocryl suture closure
Bandgrip Micro-Anchor Skin Closure	Bandgrip Micro-Anchor Wound Closure	-

Primary Outcome Measures

Name	Time	Method
Number of patients with wound healing complications	From time of surgery to 30 days post-op	All wound-related complication following surgery

Secondary Outcome Measures

Name	Time	Method
Closure time of surgical wound	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)	Time (in seconds) that it takes to close the incisional wound during surgery

Trial Locations

Locations (1)

Rothman Orthopaedics; 🇺🇸 Philadelphia, Pennsylvania, United States