Early Feasibility Study of a Novel Negative Pressure Wound Therapy Glove for 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
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
August 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 26, 2024
January 1, 2024
11 months
April 7, 2023
October 22, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Did significant adverse events occur
Did infection or skin injury occur
0-7 days
Skin remains intact
Did maceration occur.
0-7 days
Dressing changes
Total number of dressing changes.
0-7 days
Additional adverse events
Type and severity of adverse events.
0-7 days
Secondary Outcomes (5)
Hand Function (through range of motion)
7 days to 12 weeks
Hand Function (through range of motion)
7 days to 12 weeks
Hand Function (grip and pinch strength)
7 days to 12 weeks
Time to healing
7 days to 12 weeks
Incidence of additional surgical procedure/interventions
7 days to 12 weeks
Study Arms (1)
Soft tissue hand injury
EXPERIMENTALInterventions
ReHeal glove hand dressing with Negative Pressure Wound Therapy (NPWT).
Eligibility Criteria
You may qualify if:
- 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
- +5 more criteria
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher H Allan, MD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, School of Medicine
Study Record Dates
First Submitted
April 7, 2023
First Posted
May 6, 2023
Study Start
August 15, 2024
Primary Completion
June 30, 2025
Study Completion
December 1, 2025
Last Updated
October 26, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share