New Dressing for Burns

Overseen By Marc G Jeschke, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hamilton Health Sciences Corporation

Disqualifiers: Moribund, Pregnancy, Active cancer, others

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

Compensation: Varies

Number of Visits: 3

Duration: Up to 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dressing, called Product X, for patients with burns requiring skin grafts. The focus is on whether Product X better manages pain, itch, and infection at the donor site, where skin is taken for grafting, compared to current dressings. Participants with significant burns on areas like the thigh, torso, or arm, who need these grafts, may be suitable candidates. During the trial, participants will have one or two donor sites treated with either Product X or standard dressings and will report on their comfort and healing progress. Researchers will compare the results to determine if Product X offers better healing and comfort. As an unphased trial, this study allows participants to contribute to innovative research that could improve burn treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this dressing is safe for burn patients?

Research has shown that hydrogel-based burn dressings, such as Product X, are generally well-tolerated by patients. These dressings often provide a cooling effect and help soothe burns. For example, hydrogel dressings are considered safe for children and for use on facial burns, indicating they are gentle and non-irritating.

Other studies have found that these dressings help keep the skin moist and cool, offering temporary pain relief. Notably, no major health risks have been reported with these dressings, suggesting they are safe for regular use.

While Product X is still under study, the safety record of similar hydrogel burn dressings indicates they are well-tolerated, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Product X is unique because it offers a new approach to treating burns by potentially enhancing healing and reducing infection risk compared to standard dressings. Unlike traditional dressings, which mainly cover and protect the wound, Product X might incorporate advanced materials or technologies that actively promote skin regeneration or deliver antimicrobial agents directly to the wound site. Researchers are excited about this treatment because it could speed up recovery and improve outcomes for burn patients, making the healing process more efficient and less painful.

What evidence suggests that this new dressing is effective for burn donor sites?

Research has shown that burn wound dressings like Product X, which participants in this trial may receive, aim to reduce pain and speed up healing. Studies have found that advanced dressings can help prevent infections and absorb fluids better than some current options. Product X is designed as an "ideal dressing," focusing on pain relief and effective fluid absorption, which are crucial for healing areas where skin is taken for grafts. Early results suggest that these improved dressings can lead to faster recovery and less discomfort for patients. These advancements in wound care hold promise for those needing skin grafts after burns. ^{6 7 8 9 10}

Who Is on the Research Team?

Marc G Jeschke, MD PhD

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with deep burns covering less than a quarter of their body, needing skin grafts from their thigh, torso, or arm. It's not for those at the end of life, pregnant women, or active cancer patients under treatment.

Inclusion Criteria

Less than 25% of my body has been burned.

I have suitable tissue on my thigh, torso, or arm for donation.

I have a severe burn that needs surgery.

Exclusion Criteria

Patients who are moribund

Pregnancy

I am currently receiving treatment for my active cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Product X or standard-of-care dressings, with photographs and questionnaires completed during dressing changes and at discharge.

Up to 52 weeks

Regular visits for dressing changes and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including scar formation and healing assessments at 3 and 6 months post-discharge.

6 months

Follow-up appointments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Product X
• Standard-of-Care

Trial Overview The study tests Product X against standard dressings (Allevyn and Xeroform) in managing donor sites after skin grafting. Participants are randomly assigned to either Product X or standard care and monitored through photos, daily comfort surveys, and scar assessments.

How Is the Trial Designed?

Group I: Product X Experimental Treatment 1 Intervention

Group II: Standard-of-Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4464872/

Burn wound healing and treatment: review and advancements This article reviews recent advancements in the care of burn patients with a focus on the pathophysiology and treatment of burn wounds.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4268627/

Healing of burn wounds by topical treatment - PubMed Central AgNP can be an effective and superior alternative to SSD for burn wounds, particularly 2° deep-dermal burns. Healing can be expected, in general, in 6 to 8 ...

3. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-024-03901-2

Advancements in cell-based therapies for thermal burn wounds Our study showed that employing cell-based therapies for the treatment of burn wounds have significant results in clinical studies and are promising approaches.

4. medrxiv.org medrxiv.org/content/10.1101/2022.11.14.22282317v1.full-text

How effective are commercialized products used in the ... The knowledge of the existence, efficacy and mode of action of alternative therapies improve the proper management of burn wounds in clinical ...

5. mdpi.com mdpi.com/2306-5354/12/4/428

Review on Current Advancements in Facilitation of Burn ... This review summarizes current research on various approaches to enhance burn wound recovery, including advancements in wound dressings, the use of platelet- ...

6. life-assist.com life-assist.com/products/details/2031/water-jel-first-responder-burn-dressings/?srsltid=AfmBOopKLuO-imjiqL7f00SggVjRlVf_7EoRVFmvsf5SLmGMecEiebTm

WATER-JEL First Responder Burn Dressings Water-JEL Burn Dressing Safety Data Sheet · Burn Dressing Overview · Burn Jel Bottle and Packet Safety Data Sheet · Burn Jel Overview · Burn Kit Specifications.

7. gearbags.com gearbags.com/shop/supplies/first-aid-and-meds/lightning-x-cooling-burn-relief-gel-4-x-4-burn-dressing/?srsltid=AfmBOoogPSbVRpNjCfdCAJzeGoBcWYMld8KjIEPihznejEniX_vEkF9m

Hydrogel Burn Dressing | 4" x 4" - GearBags.com Safe for use on children and facial burns; For major burns, seek immediate medical care; 4″ x 4″ foam dressing contains 1.4 ounces (40 grams) of hydrogel.

8. first-aid-product.com first-aid-product.com/burn-care-first-aid-and-safety/burn-dressings-and-blankets/xeroburn-sterile-burn-dressing-4in-x-4in.html?srsltid=AfmBOoq6bD_An2R2wTWrL0bWffvCh10RDx1Q2zpZqV-RwrK53dLOMnVY

XeroBurn Sterile Burn Dressing 4" X 4" Temporary relief of pain associated with minor burns by soothing and moisturizing the burn · Provides cooling pain relief · Designed for first aid use.

9. s3-ap-southeast-2.amazonaws.com s3-ap-southeast-2.amazonaws.com/wc-prod-pim/Asset_Documents/Burnex%20Burn%20Hydrogel%20SDS.pdf

Burnex Burn Hydrogels Have SDS on hand when you call. Contact of Poisoning: From available evidence, this product would appear to offer no significant health hazard by any exposure.

10. amazon.com amazon.com/Lightning-Cooling-Dressing-Sterile-Hydrogel/dp/B079TDWM37

Lightning X Products Cooling Burn Relief Gel 4x4 Inch ... Foam dressing with cooling gel for fast heat dissipation · Safe for use on children and facial burns · Promotes healing, moistens, cools and soothes · Non-adherent ...