Bandgrip vs Traditional Sutures TJA

NCT05166642 | Suspended FDA Device

• 1 other identifier: Bandgrip001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of patients with wound healing complications

  All wound-related complication following surgery

  From time of surgery to 30 days post-op

Secondary Outcomes (1)

• 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)

Study Arms (2)

Bandgrip Micro-Anchor Skin Closure

ACTIVE COMPARATOR

Device: Bandgrip Micro-Anchor Wound Closure

Standard of Care wound closure

ACTIVE COMPARATOR

Standard Monocryl suture closure

Device: Suture closure

Interventions

Bandgrip Micro-Anchor Wound Closure 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

Bandgrip Micro-Anchor Skin Closure

Suture closure DEVICE

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

Standard of Care wound closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female greater than 18 years of age
• Scheduled to undergo primary total knee or total hip replacement
• Able to read and comprehend informed consent form and comply with the follow-up evaluation schedule

You may not qualify if:

• Prior surgical incision or scar in close proximity of the proposed incision (\<2 cm).
• Local skin conditions such as dermatitis, eczema, or psoriasis.
• Active or previous infection in the skin or the hip or knee to be operated.
• Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use
• Subject has a recent history of bleeding, coagulation and/or clotting disorders
• Subject has a known allergy to BandGrip material (polycarbonate)

Sponsors & Collaborators

• Center for Innovation and Research Organization: lead

Study Sites (1)

Rothman Orthopaedics

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Sutures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 22, 2021
• Study Start: March 8, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

US (1)