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

NCT05844943 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-26

No results posted yet for this study

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

Interventions

DEVICE

ReHeal glove with Negative Pressure Wound Therapy (NPWT)

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

Sponsors & Collaborators

Principal Investigators

  • Christopher H Allan, MD · University of Washington

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2025-06-30
Completion
2025-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844943 on ClinicalTrials.gov