RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-15
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05844943

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Persons 22 years or older
  2. * Wound size greater than 1cm2
  3. * Patient will have surgery to treat the wound, warranting the use of a dressing after surgery
  4. * Patient must be able to give informed consent
  5. * Persons who can read and write in English
  6. * Acute, unilateral, and isolated open finger or hand injuries caused by:
  7. * Burn
  8. * Blast
  9. * Abrasion
  10. * Avulsion
  11. * Amputation
  12. * Mangling hand injury
  13. * post-compartment syndrome release ((fasciotomy) and debridement
  14. * flexor tendon repair
  15. * exposed nerve or tendon
  16. * open wounds not yet ready for flap or graft
  17. * wounds after graft or flap
  18. * 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).
  19. * Fasciectomy
  20. * Tenolysis
  1. * • Polytrauma outside of the hand
  2. * Malignancy in the wound
  3. * Patient undergoing active chemotherapy
  4. * Hand wound with any untreated infection
  5. * Contaminated wounds not yet debrided
  6. * Insensate hand
  7. * Non-debrided tunneling wounds
  8. * Necrotizing soft-tissue infections
  9. * Osteomyelitis
  10. * Fractures requiring stabilization.
  11. * Untreated non-enteric fistulas
  12. * Smoker
  13. * Hemophiliac
  14. * Sepsis
  15. * Active cellulitis in the wound area
  16. * Radiation applied directly to the wound
  17. * 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).
  18. * Patients chronically treated with any of the following medications:
  19. * Anti-coagulants
  20. * Immunosuppressants
  21. * Corticosteroids
  22. * NSAIDs

Contacts and Locations

Study Contact

Karen Adams
CONTACT
206 354 3360
knadams1@uw.edu

Principal Investigator

Christopher H Allan, MD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Christopher H Allan, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Hand Injuries