Negative Pressure Wound Therapy Glove for Hand Injuries

Overseen By Karen Adams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anti-coagulants, Immunosuppressants, Corticosteroids, NSAIDs

Disqualifiers: Polytrauma, Malignancy, Infection, Smoker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special glove designed to heal hand injuries. Known as the ReHeal Glove or Negative Pressure Wound Therapy Glove, it uses negative pressure (a gentle suction) to promote faster recovery of soft tissue wounds on the hand. People with recent hand injuries from burns, blasts, or similar trauma who have had surgery and need a dressing afterward might be suitable for this study. The goal is to determine if the glove can be safely worn continuously for up to 96 hours and improve healing over a 7-week period. As an unphased trial, this study allows patients to contribute to innovative research that could enhance recovery options for hand injuries.

Will I have to stop taking my current medications?

Yes, if you are chronically taking anti-coagulants, immunosuppressants, corticosteroids, or NSAIDs, you will need to stop these medications to participate in the trial.

What prior data suggests that the ReHeal Glove is safe for use on hand injuries?

Research has shown that negative pressure wound therapy (NPWT) is generally well-tolerated and can aid in healing complex hand injuries. The ReHeal Glove employs this technology, facilitating early movement and promoting wound healing. Although specific safety data for the ReHeal Glove is not detailed, negative pressure wound therapy is a well-known and typically safe method.

Made of soft silicone, the ReHeal Glove is gentle on the skin and allows doctors to examine the wound without causing pain. This design helps prevent further injuries and supports safe recovery. Importantly, the glove undergoes initial testing on healthy volunteers to ensure it can be worn continuously for up to 96 hours without issues. Testing on healthy individuals identifies potential problems before use on injured patients, providing an extra layer of safety assurance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ReHeal Glove is unique because it uses negative pressure wound therapy (NPWT) to treat soft tissue hand injuries, which is a novel approach compared to traditional methods like dressings and ointments. Most treatments for hand injuries focus on covering and protecting the wound, but the ReHeal Glove actively promotes healing by applying controlled suction to the injury. This method can potentially speed up the healing process and reduce infection risk, making it an exciting development for both patients and healthcare providers. Researchers are particularly interested in seeing if this glove can offer faster recovery times with fewer complications compared to existing treatments.

What evidence suggests that the ReHeal Glove is effective for soft tissue hand injuries?

Research has shown that negative pressure wound therapy (NPWT) can aid in healing complex hand injuries. In this trial, participants will use the ReHeal Glove, which applies NPWT by creating a gentle vacuum around the wound to promote healing. Unlike traditional bandages that immobilize the hand, this glove permits early movement during recovery. Made of flexible silicone, it allows doctors to easily inspect the wound without frequently removing the glove. By combining NPWT with flexibility, the ReHeal Glove aims to accelerate recovery and enhance healing for hand injuries. ^{2 3 4 5 6}

Who Is on the Research Team?

Christopher H Allan, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 22 with hand injuries larger than 1cm2 requiring surgery and post-surgery dressing. Participants must understand English to give informed consent. It's suitable for various wound types like burns, abrasions, or amputations.

Inclusion Criteria

I am 22 years old or older.

I have had an amputation.

My wound is larger than 1cm squared.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 3 days post-surgery

1 visit (in-person)

Treatment with Glove

Initial application of the ReHeal Glove post-surgery, with dressing changes every 48-72 hours

Up to 7 days

Multiple visits for dressing changes

Follow-up

Participants are monitored for wound healing and safety after glove removal

Up to 6 weeks

Regular visits for wound assessment

Long-term Follow-up

Monitoring of hand function and any additional interventions

7 days to 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ReHeal Glove

Trial Overview The study tests a ReHeal Glove using Negative Pressure Wound Therapy on hand injuries. It's an early-stage trial at one center where injured patients use the glove up to 7 days post-surgery, with follow-ups lasting up to six weeks for healing assessment.

How Is the Trial Designed?

Group I: Soft tissue hand injury Experimental Treatment 1 Intervention

ReHeal Glove is already approved in United States for the following indications:

Approved in United States as ReHeal Glove for:

• Soft tissue trauma in the hand

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

The use of negative pressure wound therapy (NPWT) for skin graft fixation on the hand was successful in four patients, with all grafts taking without complications, demonstrating its efficacy in this challenging area.

The innovative 'glove-shaped' NPWT technique eliminated the need for joint fixation, potentially preventing growth disturbances and joint contractures in pediatric patients, which is a significant advantage over traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glove-shaped Foam with Negative Pressure Wound Therapy for Skin Graft Fixation on the Hand. Yoshida, E., Maeda, S., Nuri, T., et al.[2023]

The 'Hand Vac' technique, which uses a self-fabricated sponge glove for negative-pressure wound therapy, effectively managed a severe hand infection in a diabetic patient, preventing the need for amputation.

This novel approach allowed for progressive granulation and healing of extensive soft-tissue defects, ultimately leading to successful coverage with skin grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-Assisted Therapy for Combined Volar-Dorsal Soft-Tissue Defects of the Hand: A Case Report. Klein, DS., Yingling, JM., Patel, P., et al.[2023]

Negative-pressure wound therapy is a newer method for managing wounds, but it carries significant risks such as bleeding, infection, and issues with dressing materials.

Due to these potential complications, the FDA has issued warnings and emphasized the importance of clinician awareness and preparedness to mitigate risks during the use of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Risks Associated With Negative-Pressure Wound Therapy: Strategies for Clinical Practice. Mattox, EA.[2018]

The custom negative pressure wound therapy (NPWT) 'mitten' technique is designed specifically for pediatric patients, addressing the challenge of using standard adult-sized NPWT dressings for small children's hands.

This innovative approach allows for effective skin grafting in children while benefiting from the advantages of NPWT, such as reduced dressing changes and improved healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simplified negative pressure wound therapy in pediatric hand wounds. Kasukurthi, R., Borschel, GH.[2021]

Using sterile surgical gloves for dressing burn wounds in children is a practical approach that offers low cost and easy availability.

This method enhances patient compliance and reduces the risk of wound infection, making it a beneficial option for wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Hand inside glove': Useful method of burn dressing in children. Sahu, RK., Midya, M.[2020]

Negative pressure wound therapy is a crucial advancement in wound care, and its effectiveness relies heavily on the design and application of specialized products.

Key factors for developing and evaluating these products include their physical and chemical properties, biocompatibility, intended use, and risk warnings, which are essential for ensuring safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Point on Consideration of Products for Negative Pressure Wound Therapy Design and Evaluation]. Ren, Y.[2021]

This pilot randomized control trial will evaluate the feasibility, acceptability, and safety of using negative pressure wound therapy (NPWT) in managing pediatric hand and foot burns, with a focus on preventing hypertrophic scars and contractures.

The study will involve 30 participants aged 16 years or younger, comparing standard care with NPWT, and will assess outcomes such as time to re-epithelialization, pain, itch, cost, and scar formation over a 3-month period post-burn.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial. Lumsden, E., Kimble, R., McMillan, C., et al.[2023]

A new bag-type negative pressure wound therapy allows for early finger exercises after hand surgery, which is crucial for rehabilitation, as demonstrated in 4 patients with various hand injuries.

This innovative therapy resulted in good granulation and joint motion recovery, achieving a total active motion (%TAM) of 94.7% or more in most cases, and even promoted nail regeneration in fingertip injuries, eliminating the need for skin grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy incorporating early exercise therapy in hand surgery: bag-type negative pressure wound therapy. Hasegawa, K., Namba, Y., Kimata, Y.[2017]

Topical negative-pressure dressings, particularly a gauze-based system, have been successfully used for managing complex hand injuries, providing effective splinting in a functional position.

This method promotes wound healing and minimizes postoperative stiffness more efficiently than traditional dressings and plaster casts, making it a valuable technique in treating complex hand injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional splinting of upper limb injuries with gauze-based topical negative pressure wound therapy. Taylor, CJ., Chester, DL., Jeffery, SL.[2015]

Negative pressure wound therapy (NPWT) is an effective treatment for both acute and chronic wounds, promoting healing in complicated defects.

The use of specialized accessories in NPWT enhances its application and safety, particularly for high-risk tissues, as demonstrated by selected case reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects and use of negative pressure wound therapy - a set of case reports. Brzulová, L., Škach, J., Kocmanová, K., et al.[2020]

Negative pressure wound therapy (NPWT) can be effectively applied in hand surgery using surgical gloves to prevent air leaks, as demonstrated in two cases involving complex hand injuries.

In both cases, NPWT facilitated the management of wound exudate and promoted healthy granulation tissue formation, leading to successful surgical interventions and recovery of hand function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Pressure Wound Therapy with Surgical Gloves to Repair Soft Tissue Defects in Hands. Fujitani, T., Zenke, Y., Shinone, M., et al.[2015]

In a small study with six patients, maintaining negative pressure wound therapy (NPWT) during hyperbaric oxygen therapy (HBOT) was shown to be safe and effective, with no increase in pain levels reported.

The use of NPWT during HBOT resulted in better wound dressing appearance and effective exudate removal, indicating that this combined approach could enhance wound care without discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of negative-pressure wound therapy while undergoing hyperbaric oxygen therapy. Chong, SJ., Kwan, TM., Weihao, L., et al.[2018]

Citations

1. seed.nih.gov seed.nih.gov/portfolio/nih-funded-projects/poc-funded-tech/reheal-glove

ReHeal Glove The ReHeal glove is a flexible textured silicone glove. It is translucent so wound healing assessments can be made without frequent painful and possibly ...

2. withpower.com withpower.com/trial/phase-wounds-and-injuries-5-2023-15a2c

Negative Pressure Wound Therapy Glove for Hand Injuries Research shows that negative pressure wound therapy (NPWT) can help heal complex hand injuries by promoting wound healing and allowing early exercise, which is ...

3. sop.washington.edu sop.washington.edu/healing-hands/

Healing Hands - UW School of Pharmacy The result is a promising prototype device called the ReHeal Glove, which will be pilot tested with patients in the next few months using a combination of ...

4. utari.uta.edu utari.uta.edu/research/biomedical-technologies/wound-healing-device-development/

Wound Healing Device Development Unlike traditional dressings that immobilize the hand, the REHEAL glove allows for safe, early movement while delivering negative pressure wound therapy (NPWT) ...

5. els2.comotion.uw.edu els2.comotion.uw.edu/product/reheal-glove-smart-glove-for-regenerative-healing-of-extremity-trauma

Smart Glove for Regenerative Healing of Extremity Trauma The ReHeal glove is a system for applying negative pressure wound therapy to the complex contours and anatomies of hands, feet, or digits.

6. trialx.com trialx.com/clinical-trials/listings/321947/early-feasibility-study-of-a-novel-negative-pressure-wound-therapy-glove-for-hand-injuries/

Early Feasibility Study of a Novel Negative Pressure Wound ... Overview. Single-center nonrandomized single-arm early feasibility study of participants with soft tissue trauma in the hand.