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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment ReHeal Glove, 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 crucial for recovery. Studies have demonstrated that NPWT can effectively manage hand wounds, improve joint motion, and avoid the need for skin grafts in some cases. ^{1 2 3 4 5}

Is the Negative Pressure Wound Therapy Glove safe for use in humans?

Negative Pressure Wound Therapy (NPWT) has been associated with some serious complications like bleeding and infection, and the FDA has issued warnings about these risks. However, studies have shown that NPWT can be used safely with careful monitoring and management, and it has been successfully used in hand injuries with good outcomes. ^{6 7 8 9 10}

How is the ReHeal Glove treatment different from other treatments for hand injuries?

The ReHeal Glove, a type of negative pressure wound therapy (NPWT), is unique because it is designed to fit the hand like a glove, allowing for better management of air leaks and enabling early exercise therapy, which is crucial for hand function recovery. This glove-shaped design provides even pressure on irregular wounds and highly mobile areas, reducing the need for joint fixation and minimizing complications like joint contracture. ^{4 5 10 11 12}

Research Team

Christopher H Allan, MD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Functional splinting of upper limb injuries with gauze-based topical negative pressure wound therapy. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Vacuum-Assisted Therapy for Combined Volar-Dorsal Soft-Tissue Defects of the Hand: A Case Report. [2023]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

The effects and use of negative pressure wound therapy - a set of case reports. [2020]

4. Japan pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy incorporating early exercise therapy in hand surgery: bag-type negative pressure wound therapy. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Simplified negative pressure wound therapy in pediatric hand wounds. [2021]

6. China pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England 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. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Maintenance of negative-pressure wound therapy while undergoing hyperbaric oxygen therapy. [2018]

10. Japan pubmed.ncbi.nlm.nih.gov

Negative Pressure Wound Therapy with Surgical Gloves to Repair Soft Tissue Defects in Hands. [2015]

11. India pubmed.ncbi.nlm.nih.gov

'Hand inside glove': Useful method of burn dressing in children. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Glove-shaped Foam with Negative Pressure Wound Therapy for Skin Graft Fixation on the Hand. [2023]