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Silver-Plated Technology for Radiation Dermatitis
Pittsburgh, PA
N/A
Waitlist Available
Led By Parul N Barry, MD
Research Sponsored by Parul Barry
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG score must be ≤ 2
Be older than 18 years old
Must not have
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
Prior RT to the breast +/- regional lymph nodes or prior RT to the chest wall and regional lymph nodes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at on treatment visits weeks 1, 2, 3, 4, at 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial will include patients who are receiving whole breast radiotherapy with or without regional nodal irradiation. Patients will use Silver-plated technology dressing as directed and change dressings weekly. They will continue
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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions to the silver-plated dressing material. However, specific side effects related to this intervention are not detailed in the provided information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than 50% of my waking hours.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active connective tissue disorder like lupus or scleroderma.
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I have had radiation therapy to my breast or chest wall and nearby lymph nodes.
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I am not pregnant or breastfeeding and willing to use birth control during treatment.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 month following completion of rt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month following completion of rt
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Grade 2 or greater acute radiation dermatitis (ARD)
Secondary study objectives
Patient satisfaction with silver-plated technology (SPT) dressing
Radiation Therapy (RT) Completion with use of silver-plated technology (SPT)
Radiation-Induced Skin Reaction Assessment Scale (RISRAS)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Closest Location:UPMC Magee-Womens Hospital· Pittsburgh, PA· 163 miles
Who is running the clinical trial?
Bravida MedicalUNKNOWN
Parul BarryLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Parul N Barry, MDPrincipal InvestigatorUPMC Magee-Womens Hospital