Silver-Plated Technology for Radiation Dermatitis

Overseen By Samantha Demko, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Parul Barry

Disqualifiers: Prior RT, Pregnancy, Connective tissue disorders, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 1

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special silver-plated dressing to reduce skin problems from radiation therapy for breast cancer. Participants will use the dressing as directed during radiation and for two weeks afterward to determine if it lessens skin irritation and damage. The trial seeks individuals with breast cancer scheduled for radiation therapy at Magee Women's Hospital who are willing to follow the dressing instructions. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance skin care during radiation therapy.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this silver-plated technology is safe for treating radiation dermatitis?

Research has shown that dressings with silver-plated technology, such as Silverlon, are generally easy to use. Studies have found that these dressings can be safely applied to skin problems caused by radiation treatment. The FDA has approved Silverlon for these uses.

A previous study demonstrated that pure silver-plated wound dressings helped reduce skin issues from radiation treatment, suggesting they might be a safe choice for managing skin problems during radiotherapy.

These dressings are designed for use up to seven days, aligning well with typical treatment schedules. Past patients have used them without major problems, indicating they are safe for most people. It is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about silver-plated technology (SPT) dressings for radiation dermatitis because they offer a unique way to protect and heal the skin. Unlike standard treatments like topical creams and ointments, which primarily soothe symptoms, SPT dressings actively incorporate silver, known for its antimicrobial properties, to prevent infections. Moreover, these dressings provide a protective barrier that can be worn for extended periods, potentially enhancing comfort and reducing skin irritation during radiation therapy. This innovative approach could significantly improve the quality of life for patients undergoing radiation treatment.

What evidence suggests that Silver-Plated Technology is effective for radiation dermatitis?

Research shows that silver-plated technology (SPT) dressings can reduce skin irritation caused by radiation in patients receiving radiotherapy. These dressings possess antimicrobial properties, helping to prevent skin problems during radiation treatment. The FDA has approved silver-plated dressings for managing radiation-related skin issues, confirming their effectiveness in treating these conditions. Initial findings support their use as a helpful treatment option for people undergoing radiation therapy. Participants in this trial will use the SPT dressing to further evaluate its effectiveness. ^{2 3 5 6 7}

Who Is on the Research Team?

Parul N Barry, MD

Principal Investigator

UPMC Magee-Womens Hospital

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who need adjuvant whole breast radiotherapy, with or without regional nodal irradiation. Participants will use and change weekly a Silver-plated technology (SPT) dressing during and for two weeks after their radiation treatment.

Inclusion Criteria

Patients who will receive all of their RT at Magee Women's Hospital

I agree to follow-up visits and skin checks 1 month after completing radiation therapy.

I agree to apply my usual or doctor-recommended skin care 1 hour before using the SPT dressing.

Exclusion Criteria

Known sensitivity or allergy to silver or nylon

Contraindication to the application of SPT dressing (e.g. allergy)

My radiation therapy is planned for more than 4 weeks or less than 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive adjuvant whole breast radiotherapy with or without regional nodal irradiation

3-4 weeks

Weekly visits for radiation therapy

SPT Dressing Treatment

Participants use Silver-plated technology (SPT) dressing during radiation therapy and for 2 weeks following completion

5-6 weeks

Weekly dressing changes

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of ARD severity

4 weeks

1 visit at one month post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Silver-plated technology (SPT) dressing

Trial Overview The study tests if SPT dressings can help reduce acute radiation dermatitis in patients undergoing post-surgery radiotherapy for breast cancer. The severity of skin reactions will be monitored weekly during treatment and one month after completion.

How Is the Trial Designed?

Group I: Silver-Plated Technology dressing Experimental Treatment 1 Intervention

SPT dressing (Silverlon) worn for at least for 18 hours a day (removed while showering, bathing, and while having radiation therapy)

Who Is Running the Clinical Trial?

Parul Barry

Lead Sponsor

Trials

2

Recruited

40+

Bravida Medical

Collaborator

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06831084

Acute Radiation Dermatitis After Adjuvant Radiotherapy for ... Silver-plated technology (SPT) dressing, a novel skin dressing, has been shown to have anti-microbial effects thereby reducing the development of ARD. This ...

2. oncologynurseadvisor.com oncologynurseadvisor.com/reports/head-neck-cancer-pure-silver-plated-wound-dressings-treatment-risk/

Pure Silver-Plated Wound Dressings May Reduce ... The use of pure silver-plated wound dressing appeared to reduce the incidence of radiation dermatitis (RD) in patients receiving ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9229675/

Modern Dressings in Prevention and Therapy of Acute and ... The most effective ways of preventing acute radiation dermatitis are film dressings, whereas foam dressings were found effective in its treatment.

4. bravidamedical.com bravidamedical.com/silverlon-receives-fda-510k-clearance-for-radiation-dermatitis-and-cutaneous-radiation-injury/

Silverlon Receives FDA 510k Clearance for Radiation ... This is truly a unique clearance, a dual-role clearance, which has immediate medical treatment benefits to manage radiation dermatitis, a common ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221218.pdf

K221218 - accessdata.fda.gov Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for radiation dermatitis and cutaneous radiation injury ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/28/NCT04238728/Prot_SAP_002.pdf

An unblinded, open-label study evaluating the safety of ... PURPOSE, BACKGROUND, AND OBJECTIVES. 1.1. PURPOSE. This is a safety study of a commercially available silver-nylon burn dressing (Silverlon®.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301612004592

Silver Clear Nylon Dressing is Effective in Preventing ... Silver Clear Nylon Dressing is Effective in Preventing Radiation-Induced Dermatitis in Patients With Lower Gastrointestinal Cancer: Results From a Phase III ...