Early Feasibility Study of a Novel Negative Pressure Wound Therapy Glove for Hand Injuries

Launched by UNIVERSITY OF WASHINGTON · May 3, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of glove designed to help heal hand injuries by creating a negative pressure environment, which can promote wound healing. The study will first test the safety of wearing this glove for up to 96 hours on healthy volunteers before allowing people with actual hand injuries to participate. Eligible participants are adults aged 22 and older with specific types of hand injuries, such as burns, abrasions, or injuries requiring surgery. To join, they must also be able to provide informed consent and read and write in English.

If someone is selected to participate, they will wear the ReHeal Glove for up to 7 days, with regular changes to the dressing every 48-72 hours as needed. After the glove is removed, participants will be monitored for up to 6 weeks to ensure their wounds heal properly. This is an exciting opportunity for those with certain hand injuries to potentially benefit from a new treatment while helping researchers learn more about its effectiveness and safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Persons 22 years or older
• • Wound size greater than 1cm2
• • Patient will have surgery to treat the wound, warranting the use of a dressing after surgery
• • Patient must be able to give informed consent
• • Persons who can read and write in English
• * Acute, unilateral, and isolated open finger or hand injuries caused by:
• • Burn
• • Blast
• • Abrasion
• • Avulsion
• • Amputation
• • Mangling hand injury
• • post-compartment syndrome release ((fasciotomy) and debridement
• • flexor tendon repair
• • exposed nerve or tendon
• • open wounds not yet ready for flap or graft
• • wounds after graft or flap
• • crush injuries associated with fractures (open or closed) which do not require stabilization and can therefore accommodate hand motion (for example, an abrasion injury may involve loss of some portion of cortical bone due to friction without losing structural stability sufficient to permit finger motion).
• • Fasciectomy
• • Tenolysis
• Exclusion Criteria:
• • • Polytrauma outside of the hand
• • Malignancy in the wound
• • Patient undergoing active chemotherapy
• • Hand wound with any untreated infection
• • Contaminated wounds not yet debrided
• • Insensate hand
• • Non-debrided tunneling wounds
• • Necrotizing soft-tissue infections
• • Osteomyelitis
• • Fractures requiring stabilization.
• • Untreated non-enteric fistulas
• • Smoker
• • Hemophiliac
• • Sepsis
• • Active cellulitis in the wound area
• • Radiation applied directly to the wound
• • Patients with allergies to product components: silicone, silicone adhesives and polyurethane films (direct contact with wounds), acrylic adhesives (direct contact with skin), polyethylene fabrics, and super-absorbent powders (polyacrylates within the dressing).
• * Patients chronically treated with any of the following medications:
• • Anti-coagulants
• • Immunosuppressants
• • Corticosteroids
• • NSAIDs