MW-III vs Silver Sulfadiazine for Burns

Recruiting at 5 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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Silver Sulfadiazine for treating burns?

Research shows that Silver Sulfadiazine is effective in treating burns, with 85.7% of the wound area showing granulation tissue (new tissue formation) and 75-100% showing epithelialization (skin cell growth). It also reduces infection rates and has been found to be superior to Maphenide in reducing certain bacterial infections in burn wounds. ^{1 2 3 4 5}

Is silver sulfadiazine safe for use in humans?

Silver sulfadiazine is generally safe for treating burns, with low toxicity and few side effects. However, some uncommon side effects include allergic reactions, silver staining of the skin, and issues in people with certain enzyme deficiencies. It has a good safety record, but there are concerns about silver toxicity and resistance in some bacteria. ^{1 3 6 7 8}

How does the drug MW-III differ from silver sulfadiazine in treating burns?

MW-III is a new treatment being compared to silver sulfadiazine, which has been a standard for burn care but faces challenges like bacterial resistance. The unique aspect of MW-III could involve a different mechanism or formulation that addresses these resistance issues, although specific details about MW-III are not provided in the available research. ^{1 3 4 9 10}

What is the purpose of this trial?

To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.

Research Team

Kevin Foster

Principal Investigator

Valleywise Health Medical Center

Eligibility Criteria

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

Severe inhalation injury or other significant non-burn trauma

My burn wound is infected.

I have a burn that might need skin grafting soon.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Clinical comparison of maphenide and silver sulphadiazine. [2019]

2. Netherlands 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. [2019]

3. Sweden pubmed.ncbi.nlm.nih.gov

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

4. Canada pubmed.ncbi.nlm.nih.gov

Silver-resistant Enterobacteriaceae from hospital patients. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A small-scale re-evaluation of the efficacy of silver sulfadiazine for burns. [2021]

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

Sildimac: a new delivery system for silver sulfadiazine in the treatment of full-thickness burn injuries. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The side effects of silver sulfadiazine. [2018]

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

Silver-coated dressing acticoat caused raised liver enzymes and argyria-like symptoms in burn patient. [2022]

9. United States 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. [2013]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The role of silver sulphadiazine in the conservative treatment of partial thickness burn wounds: A systematic review. [2022]