NCT05166642

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Center for Innovation and Research Organization · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DEVICE	Suture closure	This treatment gourd will utilize suture closure technique for all layers of the surgical incision.

Timeline

• Start date: 2021-03-08
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2021-12-22
• Last updated: 2023-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study