Bandgrip vs Traditional Sutures TJA

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05166642
• Other study ID #: Bandgrip001
• Status: Suspended
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: January 2024

Study information

• Verified date: September 2023
• Source: Center for Innovation and Research Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Rothman Orthopaedics	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Center for Innovation and Research Organization

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with wound healing complications	All wound-related complication following surgery	From time of surgery to 30 days post-op
Secondary	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)