Using Silverlon® for Head and Neck Patients With Tracheostomies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorState University of New York - Upstate Medical University
About this trial
The purpose of this study is to determine if prophylactic silver-nylon burn dressing Silverlon® prevents a severe skin reaction under tracheostomy collars. It also aims to establish whether patients can tolerate Silverlon® under their tracheostomy with daily removal and weekly changes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing definitive head and neck cancer (>4 weeks of treatment)
Have a tracheostomy
Age ≥ 18 years
Must be able to understand and write English
Disqualifiers
Inability to fulfill requirements of the protocol
Presence of unhealed surgical wounds
Subjects unable or unwilling to wear Silverlon dressings
Active infection of treatment area
Trial design
Design model
Single group
Treatments tested in this trial
Silverlon®
DeviceSilverlon® is a specialized, antimicrobial wound dressings that is approved in radiation dermatitis. The study is aimed at determining if this dressing is effective in prophylactically preventing dermatitis in high risk patients.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Using Silverlon®Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Silveron dressing
The study will look at median use of the Silveron dressing. Success is defined as \> 50% over treatment days (\>17/35 days).
Time frame
7 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
State University of New York - Upstate Medical University
Lead sponsor
Bravida Medical
Collaborator
Source ClinicalTrials.gov