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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hand Injuries

Intervention / Treatment
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* Device: ReHeal glove with Negative Pressure Wound Therapy (NPWT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soft tissue hand injury<br> | Device: ReHeal glove with Negative Pressure Wound Therapy (NPWT)<br>* ReHeal glove hand dressing with Negative Pressure Wound Therapy (NPWT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand Function (through range of motion) | Total Active Motion of fingers | 7 days to 12 weeks | 
| Hand Function (through range of motion) | Opposition of thumb | 7 days to 12 weeks | 
| Hand Function (grip and pinch strength) | Grip and Pinch Strength | 7 days to 12 weeks | 
| Time to healing | Wound closure rate will be assessed by documenting wound size at each clinic visit. | 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. | 7 days to 12 weeks |