Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology

NCT ID: NCT06831084

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-05-31

Brief Summary

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.

Detailed Description

Adjuvant radiotherapy for breast cancer is standard in the setting of breast conserving therapy. The most common acute toxicity in those receiving breast radiotherapy is acute radiation dermatitis (ARD). This is not only disfiguring, but also painful and uncomfortable. No standard exists for the mitigation or treatment of ARD. Routinely, emollients and steroid based creams, including but not limited to, xeroform gauze, demeboro soaks, triple antibiotic cream, Silvadene, hydrocortisone, and mometasone creams are used. Steroid creams have been shown to change the skin microenvironment and also thin the skin - this is especially concerning as one of the primary goals of BCT is good to excellent cosmetic outcome. Mepitel dressings have been evaluated but are often cumbersome to use and difficult to apply accurately. Silver-plated technology (SPT) dressing, a novel skin dressing, has been shown to have anti-microbial effects thereby reducing the development of ARD. This prospective single arm phase II study will evaluate if SPT dressing reduces the incidence of grade 2 or higher ARD in breast cancer patients who are going to receive adjuvant radiotherapy.

Conditions

Radiation Dermatitis Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Silver-Plated Technology dressing

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

Group Type: EXPERIMENTAL

Silver plated technology (SPT) dressing

Intervention Type: DEVICE

Silver-plated technology (SPT) dressing technology is a wound dressing that has a permanently plated metallic surface, which provides the antimicrobial benefits of silver in the dressing without staining the skin and without increasing bioburden, reducing the development of acute radiation dermatitis (ARD).

Interventions

Silver plated technology (SPT) dressing

Silver-plated technology (SPT) dressing technology is a wound dressing that has a permanently plated metallic surface, which provides the antimicrobial benefits of silver in the dressing without staining the skin and without increasing bioburden, reducing the development of acute radiation dermatitis (ARD).

Intervention Type: DEVICE

Other Intervention Names

Silverlon

Eligibility Criteria

Inclusion Criteria

1. ECOG ≤ 2

2. Male or female patients with breast cancer or breast carcinoma in situ who are recommended to receive adjuvant radiotherapy to the breast +/- regional lymph nodes or are planned to receive adjuvant radiotherapy to the chest wall and regional lymph nodes over 3 to 4 weeks.

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

4. Agreeable to use of SPT dressing as directed (changing once weekly during RT and the additional 2 weeks following completion of RT).

5. Agreeable that any normal or physician recommended skin care regimen is to be used 1 hour prior to use of SPT dressing.

6. Agreeable to completion of assessments and skin checks and in person follow up at about 1 month following completion of RT.

7. Must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Prior RT to the breast +/- regional lymph nodes or prior RT to the chest wall and regional lymph nodes.

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

3. Pregnancy/lactation or women of childbearing potential who are unable or unwilling to use adequate contraception during RT.

4. Planned RT course >4 weeks or <3 weeks.

5. Active connective tissue disorders/collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash in the area that will receive RT, systemic lupus erythematosis, or scleroderma.

6. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.

7. Known sensitivity or allergy to silver or nylon.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bravida Medical

UNKNOWN

Sponsor Role: collaborator

Parul Barry

OTHER

Sponsor Role: lead

Responsible Party

Parul Barry

Clinical Assistant Professor of Radiation Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Parul N Barry, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Magee-Womens Hospital

Locations

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samantha Demko, RN

Role: CONTACT

albesl@upmc.edu

4126231400

Brieanna Marino, MS

Role: CONTACT

rowlesbm@upmc.edu

4126478258

Facility Contacts

Samatha Demko, RN

Role: primary

albesl@upmc.edu

4126231400

Brieanna Marino, MS

Role: backup

rowlesbm@upmc.edu

4126478258

Other Identifiers

HCC 24-105

Identifier Type: -

Identifier Source: org_study_id