MW-III vs Silver Sulfadiazine for Burns

Recruiting at 8 trial locations

Overseen By Eric Wang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Skingenix, Inc.

Disqualifiers: Infected burns, Compartment syndrome, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MW-III for healing burns. Researchers aim to determine if MW-III accelerates healing more effectively than the commonly used Silvadene® Cream 1% (Silver Sulfadiazine). The trial includes two groups: one using MW-III and the other using Silvadene, to compare burn healing rates. Individuals with partial thickness burns (affecting both the outer and underlying skin layers) covering less than 25% of their body may qualify for this study. Participants must have burns that are not infected and do not require immediate surgery. As a Phase 2 trial, this study measures MW-III's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that MW-III, a cream for treating burns, is undergoing tests to determine its safety and effectiveness. Earlier studies on similar treatments have found them generally safe and easy to use, with few reports of negative reactions. This suggests that MW-III might also be safe for people, but further research is necessary to confirm this.

This trial is in its early stages, so researchers are still learning about how people respond to the treatment. Until more information becomes available, consulting a healthcare provider for personalized advice is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatment for burns, which often involves creams like Silvadene® that use silver sulfadiazine to prevent infection, the investigational drug MW-III is unique because it may leverage a new mechanism of action or active ingredient. Researchers are particularly excited about MW-III because it could offer faster healing times or improved antimicrobial properties compared to existing options. This potential to enhance recovery and minimize complications is what makes MW-III stand out in the field of burn treatment.

What evidence suggests that this trial's treatments could be effective for burns?

Research on the experimental drug MW-III, which participants in this trial may receive, suggests it may accelerate burn healing. Previous studies examined the speed of re-epithelialization, the regrowth of the top layer of burned skin, aiming for at least 95% of the burn area to heal. Although detailed data from these studies remains limited, the focus is on reducing healing time. This trial will compare MW-III to Silver Sulfadiazine cream, the standard treatment, to determine if MW-III can potentially work faster than Silver Sulfadiazine, commonly used for burns. ^{1 2 6 7 8}

Who Is on the Research Team?

Kevin Foster

Principal Investigator

Valleywise Health Medical Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have a single second-degree thermal burn that happened within the last 24 hours. They must be able to consent and follow study procedures. People with multiple burns, third-degree burns, burns needing surgery, or at high risk of compartment syndrome can't join.

Inclusion Criteria

My burns cover less than 25% of my body and include at least one serious burn.

Able and willing to give informed consent and comply with study procedures

Exclusion Criteria

My burn wound is infected.

Severe inhalation injury or other significant non-burn trauma

I have a burn that might need skin grafting soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MW-III or Silvadene® Cream 1% for the treatment of thermal burns

4 weeks

Weekly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MW-III
• Silvadene® Cream 1% [Silver Sulfadiazine]
• Silver Sulfadiazine

Trial Overview The study aims to see if MW-III works faster than Silvadene Cream (Silver Sulfadiazine) in healing second-degree thermal burns. Participants will randomly receive either the investigational drug MW-III or the standard treatment with Silvadene.

How Is the Trial Designed?

Group I: Investigational Drug, MW-III Experimental Treatment 1 Intervention

Investigational Drug, MW-III

Group II: Standard of care Active Control 1 Intervention

Silvadene® Cream 1% \[Silver Sulfadiazine\]

Who Is Running the Clinical Trial?

Skingenix, Inc.

Lead Sponsor

Trials

4

Recruited

150+

Published Research Related to This Trial

The study shows that a synthetic dressing made with polyethylene glycol-400 and poly-2-hydroxyethyl methacrylate can effectively release silver sulfadiazine (AgSD) for treating burns in rats, leading to improved healing outcomes.

Using this dressing results in lower levels of silver in the blood compared to applying AgSD in a cream, while still maintaining similar blood levels of the sulfadiazine component, suggesting a safer and more effective method for drug delivery in burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of experimental burn wound infections: comparative delivery of the antimicrobial agent (silver sulfadiazine) either from a cream base or from a solid synthetic dressing. Robb, EC., Nathan, P.[2013]

Sildimac, a new drug delivery system for silver sulfadiazine, allows for sustained release of the antimicrobial, reducing the need for daily dressing changes in burn care.

In a multicenter evaluation, Sildimac was found to be as effective as the traditional method of twice-daily cleansing and application of Silvadene cream for treating full-thickness burn wounds, while also improving patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sildimac: a new delivery system for silver sulfadiazine in the treatment of full-thickness burn injuries. Miller, L., Hansbrough, J., Slater, H., et al.[2019]

Newer burn dressings have been found to promote faster wound healing compared to the traditional silver sulphadiazine (SSD) treatment, based on a systematic review of randomized controlled trials.

While SSD and the new dressings showed similar antibacterial effects, the newer options were more comfortable for patients and required fewer dressing changes, suggesting they may be a better choice for burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of silver sulphadiazine in the conservative treatment of partial thickness burn wounds: A systematic review. Heyneman, A., Hoeksema, H., Vandekerckhove, D., et al.[2022]

In a study of 645 burn injury patients, Silver Sulphadiazine (S.S.D.) was found to be more effective than Maphenide (Sulfamylon) in reducing clinical infection rates and specifically lowering the presence of Pseudomonas and Staphylococcus bacteria.

While both treatment groups showed significant reductions in E. coli and Candida albicans infections, S.S.D. also resulted in a lower mortality rate compared to Maphenide, despite an increase in pneumonia cases in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical comparison of maphenide and silver sulphadiazine. Pegg, SP., Ramsay, K., Meldrum, L., et al.[2019]

Silver sulfadiazine cream is generally safe for treating burns, but it can cause side effects like allergic reactions, silver staining, and methemoglobinemia, which may be overlooked or misinterpreted by healthcare providers.

Early post-burn leukopenia is no longer considered a side effect of silver sulfadiazine, as it can occur with other burn treatments as well, meaning it should not lead to discontinuation of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The side effects of silver sulfadiazine. Fuller, FW.[2018]

A case study of a 17-year-old boy with 30% mixed depth burns revealed that the use of the silver-coated wound dressing Acticoat led to elevated silver levels in plasma and urine, along with symptoms of hepatotoxicity and argyria-like discoloration after one week of treatment.

This report highlights the potential for silver toxicity in patients treated with Acticoat, suggesting that monitoring silver levels in plasma and urine is important to prevent adverse effects, especially given the known issues with silver sulfadiazine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silver-coated dressing acticoat caused raised liver enzymes and argyria-like symptoms in burn patient. Trop, M., Novak, M., Rodl, S., et al.[2022]

The study identified silver-resistant strains of Enterobacteriaceae, including E. coli and K. pneumoniae, in patients treated with silver sulfadiazine for burn wound prophylaxis, highlighting a potential risk of antibiotic resistance associated with silver use.

Out of 230 bacterial isolates from burn-site cultures, 97 were found to be resistant to silver, indicating that silver resistance can occur alongside sulfonamide resistance, which may complicate treatment options for infected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silver-resistant Enterobacteriaceae from hospital patients. Hendry, AT., Stewart, IO.[2019]

Silver sulfadiazine is an effective topical antibacterial treatment for burn patients, known for its low toxicity and minimal side effects, making it a safe option.

There is a growing concern about the emergence of resistant Gram-negative bacteria, such as Pseudomonas aeruginosa, which may limit the effectiveness of silver sulfadiazine, prompting research into new metal sulfadiazines to combat these resistant strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silver sulfadiazine: an antibacterial agent for topical use in burns. A review of the literature. Hoffmann, S.[2022]

A systematic review of 24 randomized clinical trials found that new dressings, both with and without silver, promote faster healing of burn wounds compared to Silver Sulfadiazine (SSD), with significant differences in healing time (p<0.0001).

Burns treated with SSD had a higher rate of infection compared to those treated with dressings without silver, indicating that newer dressing options may be safer and more effective for preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of Silver Sulfadiazine with other materials for healing and infection prevention in burns: A systematic review and meta-analysis. Nímia, HH., Carvalho, VF., Isaac, C., et al.[2019]

In a study involving seven patients with second- and third-degree burns, silver sulfadiazine was found to be effective, with 85.7% of the wound area showing granulation tissue and 75-100% showing epithelialization over a treatment period of 5 months.

Despite its effectiveness, patients experienced pain during treatment with silver sulfadiazine, indicating a need for additional nursing interventions to manage discomfort associated with burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A small-scale re-evaluation of the efficacy of silver sulfadiazine for burns. Handayani, E., Masithoh, RF.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01297400

NCT01297400 | Phase 2 Pilot Study of the Safety and ... Time to healing (≥95% re-epithelialization) of the partial thickness target burn. 28 days Treatment Period. Secondary Outcome Measures ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT01297400/phase-2-pilot-study-of-the-safety-and-efficacy-of-topical-mw-iii-in-thermal-burns

Phase 2 Pilot Study of the Safety and Efficacy of Topical ... This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.

3. trial.medpath.com trial.medpath.com/clinical-trial/b7a0c81fc8a383ae/safety-efficacy-topical-mw-iii-thermal-burns

Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III ... Time to healing (≥95% re-epithelialization) of the partial thickness target burn. 28 days Treatment Period. Time to healing (≥95% re-epithelialization) of the ...

4. 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6486072/

Tissue healing efficacy in burn patients treated with 1% ... This study aims to evaluate tissue healing efficacy in burn patients treated with 1% silver sulfadiazine versus other treatments.

6. uptodate.com uptodate.com/contents/topical-agents-and-dressings-for-local-burn-wound-care

Topical agents and dressings for local burn wound care Optimal local treatment of burn wounds depends on gentle cleansing and debridement to minimize the incidence of complicating infection as well ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12192090/

The Potential Use of Fibrin Sealants in Burn Wound ... Fibrin sealants are generally considered safe and well-tolerated when used in burn wound management, with a low incidence of adverse effects.

8. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/Detail.CFM?ID=525920

MDR Database Search - FDA BURN WAS REPORTED ON BUTTOCKS AREA 2 DAYS AFTER ELECTRODES WERE USED DURING C-SECTION SURGERY. NURSING MANAGER DOES NOT FEEL THE BURN WAS ASSOCIATED WITH THE ...