Recruiting

Negative Pressure Wound Therapy

Sponsor:

University of Washington

Code:

NCT05844943

Conditions

Hand Injuries

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

ReHeal glove with Negative Pressure Wound Therapy (NPWT)

Study Details

Brief summary:

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

Study ID

NCT05844943

Start date

Aug 15, 2024

Status verified date

Jan, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Soft tissue hand injury

Interventions

ReHeal glove with Negative Pressure Wound Therapy (NPWT)

ReHeal glove hand dressing with Negative Pressure Wound Therapy (NPWT).

Primary outcome measure

  • Did significant adverse events occur [ Time Frame: 0-7 days ]
  • Skin remains intact [ Time Frame: 0-7 days ]
  • Dressing changes [ Time Frame: 0-7 days ]
  • Additional adverse events [ Time Frame: 0-7 days ]

Central Contacts and Locations

Central contacts

Karen Adams

206 354 3360knadams1@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Brandon Bowen

206-549-1085coalcat@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Oct 26, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-10-26.