17 Participants Needed

Silver-Plated Technology for Radiation Dermatitis

BM
SD
Overseen BySamantha Demko, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Parul Barry
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.16789

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.1241011

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

PN

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.
See 4 more

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.
See 4 more

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
1Treatment groups
Experimental Treatment
Group I: Silver-Plated Technology dressingExperimental Treatment1 Intervention
SPT dressing (Silverlon) worn for at least for 18 hours a day (removed while showering, bathing, and while having radiation therapy)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Parul Barry

Lead Sponsor

Trials
2
Recruited
40+

Bravida Medical

Collaborator

Trials
1
Recruited
20+

References

Silver leaf nylon dressing to prevent radiation dermatitis in patients undergoing chemotherapy and external beam radiotherapy to the perineum. [2013]
Effectiveness of semi-permeable dressings to treat radiation-induced skin reactions. A systematic review. [2022]
Protective effect of transparent film dressing on proton therapy induced skin reactions. [2021]
Phase 2 study of silver leaf dressing for treatment of radiation-induced dermatitis in patients receiving radiotherapy to the head and neck. [2013]
Homologous platelet gel on radiation-induced dermatitis in a patient receiving head and neck radiotherapy plus cetuximab: A case report. [2023]
Effect of Film Dressing on Acute Radiation Dermatitis Secondary to Proton Beam Therapy. [2020]
Role and mechanism of radiological protection cream in treating radiation dermatitis in rats. [2019]
Evaluation of silver coated hemostatic dressing to control hemorrhage in a porcine model of lethal vascular injury. [2016]
Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial. [2023]
10.United Statespubmed.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 Statespubmed.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]
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