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

Description

Single-center nonrandomized single-arm early feasibility study of participants with soft tissue trauma in the hand. Prior to enrolling participants with hand injuries, the safety of continuous glove use for up to 96 hours without a glove replacement will be assessed on healthy volunteers. Injured participants will be on study for up to 7 weeks depending on when the final glove is removed. Screening: Prior to surgery and through 72 hours post-surgery to identify eligible patients Treatment with Glove: Treatment begins with initial application of the ReHeal Glove and can last up to 7 days (with dressing changes every 48-72 hours unless more frequent changes are requested by the treating physician.) Follow-up: Up to 6 weeks after final removal of glove to ensure complete wound healing.

Conditions

Hand Injuries

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Study Overview

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Study Details

Study overview

Single-center nonrandomized single-arm early feasibility study of participants with soft tissue trauma in the hand. Prior to enrolling participants with hand injuries, the safety of continuous glove use for up to 96 hours without a glove replacement will be assessed on healthy volunteers. Injured participants will be on study for up to 7 weeks depending on when the final glove is removed. Screening: Prior to surgery and through 72 hours post-surgery to identify eligible patients Treatment with Glove: Treatment begins with initial application of the ReHeal Glove and can last up to 7 days (with dressing changes every 48-72 hours unless more frequent changes are requested by the treating physician.) Follow-up: Up to 6 weeks after final removal of glove to ensure complete wound healing.

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

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

Condition
Hand Injuries
Intervention / Treatment

-

Contacts and Locations

Seattle

University of Washington, Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * • 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

Christopher H Allan, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2025-12-01