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

Trial Summary

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 data supports the effectiveness of the treatment Silver-plated technology (SPT) dressing for radiation dermatitis?

Research shows that silver-based dressings, like silver leaf nylon dressing, have antimicrobial properties and help in healing burns and skin grafts, which suggests they might also be effective for radiation dermatitis. Additionally, studies on similar silver dressings have shown benefits in managing skin reactions from radiation therapy. ^{1 2 3 4 5}

Is silver-plated technology safe for use in humans?

Silver-leaf nylon dressing, which is similar to silver-plated technology, has been used safely in patients to prevent skin issues during radiation therapy and has shown antimicrobial properties that help in healing. ^{1 6 7 8 9}

How does the silver-plated technology treatment for radiation dermatitis differ from other treatments?

The silver-plated technology treatment is unique because it uses silver's antimicrobial properties to prevent and heal radiation dermatitis, unlike standard treatments that may not have these properties. This approach is similar to how silver is used in burn care to enhance healing and reduce infection. ^{1 2 4 10 11}

What is the purpose of this trial?

Patients who are eligible to receive adjuvant whole breast radiotherapy with or without regional nodal irradiation as part of their care will be included in this study. Patients will use Silver-plated technology (SPT) dressing as directed per user instruction manual and change dressings weekly. Patients will continue to wear the SPT dressing for 2 weeks following completion of RT. The presence and severity of ARD will be recorded at the time of the weekly OTV and at one month after finishing the treatment.

Research Team

Parul N Barry, MD

Principal Investigator

UPMC Magee-Womens Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Silver leaf nylon dressing to prevent radiation dermatitis in patients undergoing chemotherapy and external beam radiotherapy to the perineum. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of semi-permeable dressings to treat radiation-induced skin reactions. A systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Protective effect of transparent film dressing on proton therapy induced skin reactions. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Phase 2 study of silver leaf dressing for treatment of radiation-induced dermatitis in patients receiving radiotherapy to the head and neck. [2013]

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

Homologous platelet gel on radiation-induced dermatitis in a patient receiving head and neck radiotherapy plus cetuximab: A case report. [2023]

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

Effect of Film Dressing on Acute Radiation Dermatitis Secondary to Proton Beam Therapy. [2020]

7. China pubmed.ncbi.nlm.nih.gov

Role and mechanism of radiological protection cream in treating radiation dermatitis in rats. [2019]

8. Poland pubmed.ncbi.nlm.nih.gov

Evaluation of silver coated hemostatic dressing to control hemorrhage in a porcine model of lethal vascular injury. [2016]

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

Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial. [2023]

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

Influence of antimicrobial coatings of vacuum-assisted closure dressings on methicillin-resistant Staphylococcus aureus growth kinetics: an in vitro study. [2015]

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

Phase III Study of Silver Leaf Nylon Dressing vs Standard Care for Reduction of Inframammary Moist Desquamation in Patients Undergoing Adjuvant Whole Breast Radiation Therapy. [2019]