Novel glove therapy for treating hand injuries

Part II of Two-Part Early Feasibility Study to Evaluate the Safety and Tolerability of a Novel Negative Pressure Wound Therapy Glove for Hand Injuries

This study is testing a new glove treatment for hand injuries to see if it helps patients heal safely after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT05844943 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and feasibility of a new negative pressure wound therapy glove designed for patients with hand injuries. Initially, healthy volunteers will test the glove's continuous use for up to 96 hours, ensuring safety before enrolling participants with actual injuries. Injured participants will receive the glove after surgery, with treatment lasting up to 7 weeks, including regular assessments and dressing changes. The study aims to gather data sequentially from each participant to minimize risks and ensure effective monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with specific types of acute hand injuries requiring surgical intervention.

Not a fit: Patients with chronic wounds or those not requiring surgical treatment for their hand injuries may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could enhance healing outcomes for patients with hand injuries.

How similar studies have performed: While this approach is innovative, similar negative pressure therapies have shown promise in other contexts, suggesting potential for success.

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

Where this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Christopher H Allan, MD — University of Washington
• Study coordinator: Karen Adams

Conditions Hand Injuries