Radiation Dermatitis AcuteNCT06831084
Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology
A study testing Silver plated technology (SPT) dressing in people with Radiation Dermatitis Acute, run by Parul Barry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis Acute
- What is being tested?
- Silver plated technology (SPT) dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology: A Single Arm Phase II 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.
Read the 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
- Being tested
- Silver plated technology (SPT) dressing
- Keywords
- acute radiation dermatitis (ARD), Silver-plated technology (SPT) dressing, adjuvant radiotherapy (RT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver plated technology (SPT) dressingDevice
Also called Silverlon
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Silver plated technology (SPT) dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 month post RT
Secondary outcomes (5)
Use of advanced skin care products
Proportion of patients receiving breast cancer radiation therapy (RT) over 3-4 weeks using advanced skin care products such as xeroform gauze, triple antibiotic cream, and/or Silvadene.
Measured: Up to 1 month following completion of RT
Patient satisfaction with silver-plated technology (SPT) dressing
Proportion of patients receiving breast cancer radiation therapy (RT) over 3-4 weeks who are satisfied with SPT dressing as reported on the SPT Dressing Patient Satisfaction Survey. The SPT survey includes SPT individual attributes: Ease of prep and apply, Easy for patient use, Durable for repositioning, Patient Comfort, Wear time of 7 days, Patients overall satisfaction, Caregivers overall satisfaction, by "Satisfaction Levels (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied) It also asks if the "Preferred Product" is the 'New' or 'Previous' product. There are four Yes/No questions also, inquiring as to whether the dressing provides relief when worn, able to be kept on before and after bathing, how many times cream was used to treat ARD, and understanding of directions for use. A scoring metric will be developed to quantify these results and analyze statistically. More 'satisfied' responses would indicate greater overall satisfaction with SPT.
Measured: At 1 month following completion of RT
Radiation Therapy (RT) Completion with use of silver-plated technology (SPT)
Proportion of patients receiving breast cancer radiation therapy (RT) over 3-4 weeks using SPT dressing who complete RT in comparison to historical controls.
Measured: At 1 month following completion of RT
Silver-plated technology (SPT) Dressing ARD Visual Evaluation
The SPT Dressing ARD Visual Evaluation Form employs RTOG scoring: 0=No change over Baseline, 1=Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating, 2=Tender or bright erythema, patchy moist desquamation, moderate edema, 3=Confluent moist desquamation other than skin folds, pitting edema, 4=Ulceration, hemorrhage, necrosis. Total scores: 0-24, with higher scores indicating worse ARD.
Measured: At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month
Radiation-Induced Skin Reaction Assessment Scale (RISRAS)
The Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and Distress Thermometer (DT) is a 31-point scale including 5 patient-reported domains (each scored 0-3) and 4 nurse-reported domains (each scored 0-4). The DT is solely patient-reported (0-10) and also queries specific factors contributing to distress. Patient questions include Tenderness, Discomfort, or Pain, Itch, Burning sensation, Skin reaction interfered with day to day activities, with 0-4 point ratings of "Not at all", "A little", "Quite a bit", "Very much". Nurse questions include presence/grading between 0-100% for Dry desquamation, Moist desquamation, Necrosis and coloring for Erythema between Normal and Deep Purple/Red (abnormal). Total scores: 0-36, with higher scores indicating worse ARD.
Measured: At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 May 2025
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Dermatitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parul Barry
- Sponsor type
- University, hospital or other
- Collaborators
- Bravida Medical
- Responsible party
- Sponsor-investigator, Parul Barry, University of Pittsburgh
- Investigators
- Parul N Barry, MD, Principal investigator, UPMC Magee-Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831084
- Sponsor's protocol ID
- HCC 24-105
- Status last verified
- Apr 2026
- First submitted
- 13 Feb 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Radiation Dermatitis After Adjuvant Radiotherapy for Breast Cancer Patients With the Use of Silver-Plated Technology: A Single Arm Phase II Trial
- ClinicalTrials.gov ID
- NCT06831084
- Acronym / sponsor ID
- HCC 24-105
- Conditions
- Radiation Dermatitis Acute
- Keywords
- acute radiation dermatitis (ARD), Silver-plated technology (SPT) dressing, adjuvant radiotherapy (RT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Parul BarryUniversity, hospital or other
- Collaborators
- Bravida Medical
- Study start
- 1 May 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silver-Plated Technology dressing | Experimental | Device: Silver plated technology (SPT) dressingSPT dressing (Silverlon) worn for at least for 18 hours a day (removed while showering, bathing, and while having radiation therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver plated technology (SPT) dressingAlso: SilverlonSilver-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). | Device | Silver-Plated Technology dressing |
Primary outcome
Grade 2 or greater acute radiation dermatitis (ARD)
Time frame: At 1 month post RT
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.
5 secondary outcomes
Use of advanced skin care products
Time frame: Up to 1 month following completion of RT
Patient satisfaction with silver-plated technology (SPT) dressing
Time frame: At 1 month following completion of RT
Radiation Therapy (RT) Completion with use of silver-plated technology (SPT)
Time frame: At 1 month following completion of RT
Silver-plated technology (SPT) Dressing ARD Visual Evaluation
Time frame: At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month
Radiation-Induced Skin Reaction Assessment Scale (RISRAS)
Time frame: At Baseline, At On Treatment Visits Weeks 1, 2, 3, 4, at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Radiation Dermatitis Acute
RecruitingPhase 2
Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
Radiation-induced Dermatitis
RecruitingEarly Phase 1
Adapalene Gel for Acute Radiation-Induced Skin Injury
Radiation Dermatitis
RecruitingPhase 1
Using Silverlon® for Head and Neck Patients With Tracheostomies
Head and Neck Cancer, Radiation Dermatitis Acute
Enrolling by invitationPhase 3
Oral or Topical Catechins for Radiation Dermatitis
Radiation Dermatitis Acute, Radiation Dermatitis
RecruitingPhase 1
Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
Radiation-Induced Skin Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parul N Barry, MD principal investigator
UPMC Magee-Womens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver plated technology (SPT) dressing in people with Radiation Dermatitis Acute, run by Parul Barry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 or greater acute radiation dermatitis (ARD) (time frame: At 1 month post RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.