None listed
Conditions
Brief summary
This is a prospective, randomized, single-blinded study to observe subject safety and measure efficacy of the Tonsil Dressing in the treatment of subjects post-tonsillectomy. Up to 36 subjects will be enrolled at up to 6 Australian investigational sites. Subjects will be randomized 2:1 (test:control). Tonsillectomy performed using electrodissection monopolar diathermy (10-15W). Subjects will complete self-assessments of pain (2x/day), activity and nutrition levels for 14 days. Clinic follow-up visit between days 15-25.
Interventions
Tonsil Dressing
This oral wound dressing in powder form is applied immediately post-tonsillectomy as a single intervention on the tonsillectomy wound. The powder binds to the wound becoming a gel and forms a protective barrier.
Sponsors
Medtronic Australasia Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
18 – 50 years of age Indicated for tonsillectomy due to obstructive breathing tonsil hyperplasia, tonsillitis or other chronic throat-related illness
Exclusion criteria
Prior tonsillectomy or tonsillotomy Concurrent surgical procedures (including adenoidectomy) Subject has a known shellfish allergy Body Mass Index (BMI) greater than 35 Known bleeding disorder or prescribed anticoagulants Cranial facial abnormalities that may interfere with access to the tonsils Subject is immunocompromised (e.g., taking immunosuppressive medication) Chronic or frequent use of pain medications Subject has a serious comorbid condition that may interfere with the conduct or results of the clinical study Subject is currently participating in another clinical study and has not been approved for concurrent enrolment by the Study Sponsor. Subject is pregnant or breast-feeding
Outcome results
None listed