Bandgrip vs Traditional Sutures TJA

Prospective, Randomized Clinical Trial Assessing Post-operative Wound Healing Complications Following Total Joint Arthroplasty When Using Bandgrip Incision Closure Compared to Standard Suture Closure

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 Overview

• Status: Suspended
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Bandgrip Micro-Anchor Wound Closure; Device: Suture closure

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bandgrip Micro-Anchor Skin Closure	Device: 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
Active Comparator: Standard of Care wound closure; Standard Monocryl suture closure	Device: Suture closure; This treatment gourd will utilize suture closure technique for all layers of the surgical incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with wound healing complications	All wound-related complication following surgery	From time of surgery to 30 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Closure time of surgical wound	Time (in seconds) that it takes to close the incisional wound during surgery	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)

Collaborators and Investigators

• Sponsor: Center for Innovation and Research Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Bandgrip001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No