Tonsil Dressing Feasibility Study assessing the use of an Oral Wound Dressing in Adults

Not Applicable

Completed

• Conditions: tonsil hyperplasia; tonsillitis; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12613000182796
• Lead Sponsor: Medtronic Australasia Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary purpose of this study is to measure the differences in postoperative pain in subjects undergoing electrodissection monopolar diathermy tonsillectomy who are treated with the Tonsil Dressing (treatment cohort) compared to those undergoing the same procedure who do not receive the Tonsil Dressing (control cohort). [Pain is measured by the study participant twice daily for 14 days using a visual analogue scale from 0 to 10.]