Hand InjuriesNCT05844943
Early Feasibility Study of a Novel Negative Pressure Wound Therapy Glove for Hand Injuries
A study testing ReHeal glove with Negative Pressure Wound Therapy (NPWT) in people with Hand Injuries, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- ReHeal glove with Negative Pressure Wound Therapy (NPWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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:
Show all 20Show fewer
- 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
Who cannot join
- • 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Brandon Bowen, 206-549-1085, coalcat@uw.edu
About this study
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
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.
Read more
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.
Read the detailed description
A maximum of 10 participants may be enrolled. Each participants will be enrolled sequentially, with in-depth review of study data from each individual participant before proceeding to the next participant. There will be one and only one participant at a time experiencing glove use. This allows the study team to identify and correct any safety issues before another participant is enrolled and begins glove use. This strategy is in place to minimize risk to participants. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Each participant will have the glove applied after surgery. The timing of the initial application could be immediately following surgery or up to 3 days after the surgery, at the discretion of the treating surgeon. Application delays of 1-3 days may be indicated if, in the opinion of the surgeon, the wound would benefit from a period of immobilization prior to donning the glove and allowing for the additional mobility possible with the glove dressing.
Reasons for a potential delay could include minimizing bleeding or oozing after debridement, or for protection of a skin graft. Following current standards of negative pressure wound therapy (NPWT), the wound will be assessed and the glove replaced every 48 to 72 hours. The glove may be assessed by the clinical care team and, if needed, removed and replaced earlier. At each participant encounter, data will be collected by the study team and pressure settings will be documented. At each study visit involving a dressing change, the glove will be removed for closer assessment of the wound and replaced with a new glove. Participants will remain in the study until wound healing or clinical resolution, or study exit. After study exit for each participant, data will be reviewed, and any design changes indicated by the results of the study will be implemented prior to enrollment of the next subject.
The ReHeal Glove and Cardinal Health Negative Pressure Wound Therapy Pro/Pro To Go pump will be used.
- Conditions
- Hand Injuries
- Being tested
- ReHeal glove with Negative Pressure Wound Therapy (NPWT)
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReHeal glove with Negative Pressure Wound Therapy (NPWT)Device
ReHeal glove hand dressing with Negative Pressure Wound Therapy (NPWT).
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue hand injury | Experimental | Not described Receives: Device: ReHeal glove with Negative Pressure Wound Therapy (NPWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Did significant adverse events occur
Did infection or skin injury occur
Measured: 0-7 days
Skin remains intact
Did maceration occur.
Measured: 0-7 days
Dressing changes
Total number of dressing changes.
Measured: 0-7 days
Additional adverse events
Type and severity of adverse events.
Measured: 0-7 days
Secondary outcomes (5)
Hand Function (through range of motion)
Total Active Motion of fingers
Measured: 7 days to 12 weeks
Hand Function (through range of motion)
Opposition of thumb
Measured: 7 days to 12 weeks
Hand Function (grip and pinch strength)
Grip and Pinch Strength
Measured: 7 days to 12 weeks
Time to healing
Wound closure rate will be assessed by documenting wound size at each clinic visit.
Measured: 7 days to 12 weeks
Incidence of additional surgical procedure/interventions
Where there any repeat debridement, skin grafts, flaps, or other procedures will be documented.
Measured: 7 days to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Christopher Allan, University of Washington
- Investigators
- Christopher H Allan, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844943
- Sponsor's protocol ID
- STUDY00017024
- Other IDs
- UL1TR002319
- Status last verified
- Jan 2024
- First submitted
- 7 Apr 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05844943
- Acronym / sponsor ID
- STUDY00017024
- Conditions
- Hand Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A maximum of 10 participants may be enrolled. Each participants will be enrolled sequentially, with in-depth review of study data from each individual participant before proceeding to the next participant. There will be one and only one participant at a time experiencing glove use. This allows the study team to identify and correct any safety issues before another participant is enrolled and begins glove use. This strategy is in place to minimize risk to participants. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Each participant will have the glove applied after surgery. The timing of the initial application could be immediately following surgery or up to 3 days after the surgery, at the discretion of the treating surgeon. Application delays of 1-3 days may be indicated if, in the opinion of the surgeon, the wound would benefit from a period of immobilization prior to donning the glove and allowing for the additional mobility possible with the glove dressing.
Reasons for a potential delay could include minimizing bleeding or oozing after debridement, or for protection of a skin graft. Following current standards of negative pressure wound therapy (NPWT), the wound will be assessed and the glove replaced every 48 to 72 hours. The glove may be assessed by the clinical care team and, if needed, removed and replaced earlier. At each participant encounter, data will be collected by the study team and pressure settings will be documented. At each study visit involving a dressing change, the glove will be removed for closer assessment of the wound and replaced with a new glove. Participants will remain in the study until wound healing or clinical resolution, or study exit. After study exit for each participant, data will be reviewed, and any design changes indicated by the results of the study will be implemented prior to enrollment of the next subject.
The ReHeal Glove and Cardinal Health Negative Pressure Wound Therapy Pro/Pro To Go pump will be used.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soft tissue hand injury | Experimental | Device: ReHeal glove with Negative Pressure Wound Therapy (NPWT) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- • Persons 22 years or older
Key exclusion criteria (22 listed)
- • Polytrauma outside of the hand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReHeal glove with Negative Pressure Wound Therapy (NPWT)ReHeal glove hand dressing with Negative Pressure Wound Therapy (NPWT). | Device | Soft tissue hand injury |
Primary outcome
Did significant adverse events occur
Time frame: 0-7 days
Did infection or skin injury occur
Skin remains intact
Time frame: 0-7 days
Did maceration occur.
Dressing changes
Time frame: 0-7 days
Total number of dressing changes.
Additional adverse events
Time frame: 0-7 days
Type and severity of adverse events.
5 secondary outcomes
Hand Function (through range of motion)
Time frame: 7 days to 12 weeks
Hand Function (through range of motion)
Time frame: 7 days to 12 weeks
Hand Function (grip and pinch strength)
Time frame: 7 days to 12 weeks
Time to healing
Time frame: 7 days to 12 weeks
Incidence of additional surgical procedure/interventions
Time frame: 7 days to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Hand Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Recruiting
Conservative Treatment With Relative Motion Flexion Orthosis for Boutonniere Injuries in Fingers
Finger Joint Deformities, Tendon Injuries
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher H Allan, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReHeal glove with Negative Pressure Wound Therapy (NPWT) in people with Hand Injuries, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Adams (206 354 3360, knadams1@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Did significant adverse events occur (time frame: 0-7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.