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

NCT06831084 | Completed DMC FDA Device

• 1 other identifier: HCC 24-105
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis Acute

Keywords

acute radiation dermatitis (ARD); Silver-plated technology (SPT) dressing; adjuvant radiotherapy (RT)

Outcome Measures

Primary Outcomes (1)

• Grade 2 or greater acute radiation dermatitis (ARD)

  Proportion of patients grade 2 or higher acute radiation dermatitis (ARD). ARD is defined as skin changes ranging from faint erythema (reddening) and desquamation (peeling skin) to skin necrosis (death of skin cells) and ulceration, depending on the severity of the reaction that occur in those receiving breast cancer radiation therapy (RT) over 3-4 weeks.

  At 1 month post RT

Secondary Outcomes (5)

• Use of advanced skin care products

  Up to 1 month following completion of RT

• Patient satisfaction with silver-plated technology (SPT) dressing

  At 1 month following completion of RT

• Radiation Therapy (RT) Completion with use of silver-plated technology (SPT)

  At 1 month following completion of RT

• Silver-plated technology (SPT) Dressing ARD Visual Evaluation

  At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month

• Radiation-Induced Skin Reaction Assessment Scale (RISRAS)

  At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month

Study Arms (1)

Silver-Plated Technology dressing

EXPERIMENTAL

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

Device: Silver plated technology (SPT) dressing

Interventions

Silver plated technology (SPT) dressing 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).

Also known as: Silverlon

Silver-Plated Technology dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG ≤ 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.
• Patients who will receive all of their RT at Magee Women's Hospital.
• Agreeable to use of SPT dressing as directed (changing once weekly during RT and the additional 2 weeks following completion of RT).
• Agreeable that any normal or physician recommended skin care regimen is to be used 1 hour prior to use of SPT dressing.
• Agreeable to completion of assessments and skin checks and in person follow up at about 1 month following completion of RT.
• Must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Prior RT to the breast +/- regional lymph nodes or prior RT to the chest wall and regional lymph nodes.
• Contraindication to the application of SPT dressing (e.g. allergy).
• Pregnancy/lactation or women of childbearing potential who are unable or unwilling to use adequate contraception during RT.
• Planned RT course \>4 weeks or \<3 weeks.
• 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.
• Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
• Known sensitivity or allergy to silver or nylon.

Sponsors & Collaborators

• Parul Barry: lead
• Bravida Medical: collaborator

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Parul N Barry, MD

  UPMC Magee-Womens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 17, 2025
• Study Start: May 1, 2025
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)