Bandgrip vs Traditional Sutures TJA

C

Center for Innovation and Research Organization

Status

Suspended

Conditions

Osteoarthritis

Treatments

Device: Suture closure
Device: Bandgrip Micro-Anchor Wound Closure

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT05166642
Bandgrip001

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Trial design

100 participants in 2 patient groups

Bandgrip Micro-Anchor Skin Closure
Active Comparator group
Treatment:
Device: Bandgrip Micro-Anchor Wound Closure
Standard of Care wound closure
Active Comparator group
Description:
Standard Monocryl suture closure
Treatment:
Device: Suture closure

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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