Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000182796
Ethics application status
Approved
Date submitted
13/02/2013
Date registered
15/02/2013
Date last updated
26/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Tonsil Dressing Feasibility Study assessing the use of an Oral Wound Dressing in Adults
Scientific title
Feasibility Study Assessing 14 days of Postoperative Pain after a single direct application of an Oral Wound Dressing in Post-Tonsillectomy Adults
Secondary ID [1] 281946 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tonsil hyperplasia 288361 0
tonsillitis 288390 0
Condition category
Condition code
Surgery 288709 288709 0 0
Other surgery
Oral and Gastrointestinal 288737 288737 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286509 0
Treatment: Devices
Comparator / control treatment
Control: standard treatment
Participants enrolled and randomized to the standard treatment arm will receive a tonsillectomy with standard post-operative care and no wound dressing.
Control group
Active

Outcomes
Primary outcome [1] 288853 0
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).
Timepoint [1] 288853 0
Pain is measured by the study participant twice daily for 14 days using a visual analogue scale from 0 to 10.
Secondary outcome [1] 301150 0
A secondary objective is to measure the differences in postoperative recovery time (i.e. return to normal activity and return to normal nutritional intake) in the treatment cohort compared to the control cohort.
Timepoint [1] 301150 0
Postoperative recovery time is measured by the study participant twice daily for 14 days using a questionnaire in a subject notebook.
Secondary outcome [2] 301151 0
Safety data will be collected categorized and evaluated.
Postoperative complications and events will be recorded daily by the participant in a Subject Notebook (diary) and/or reported directly to the clinic. Adverse events will be assessed by the investigator during study procedures (e.g. surgery or discharge) and with an oral cavity examination at the follow-up visit (day 15-25) and upon review of the Subject Notebook. Adverse events will be recorded on specific case report forms.
Potential Adverse events include the following:
Allergic reaction,
Post-operative bleeding,
Laryngospasm,
Dehydration,
Nausea,
Vomiting,
Foreign Body Response,
Referred Ear Pain,
Oedema,
Erythema,
Infection,
Surgical Pain,
Prolonged Surgical Pain,
Abnormal or Impaired Wound Healing,
Permanent change in voice,
Nasal regurgitation.
Timepoint [2] 301151 0
Safety data will be collected by the study participants daily for 14 days postoperatively and by the investigator at the follow-up visit occurring at day 15 - 25 postoperatively.

Eligibility
Key inclusion criteria
18 – 50 years of age
Indicated for tonsillectomy due to obstructive breathing tonsil hyperplasia, tonsillitis or other chronic throat-related illness
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be recruited from the practices and clinics of the participating Study Investigators. The potential subject will be assessed for preliminary eligibility, and subsequently interviewed for their interest in the study and willingness to comply with the study protocol. Potential candidates will be provided the Participant Information Sheet, and will be given ample opportunity to ask questions and receive further information from the study personnel before deciding whether or not they will participate in the study. If the candidate agrees to participate, he/she will be asked to sign the Informed Consent Form.
Once the Informed Consent Form is signed, the subject will be considered enrolled in the study.

Allocation is concealed through the use of central randomization by a computer system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be assigned through a computer database associated with the electronic case report form system. Once the preliminary participant information has been entered into the system the computer program will select the randomization assignment for that subject.

Simple randomisation using a randomisation table created by computer software (i.e. computerized sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a feasibility study, and the endpoints do not require a quantified definition of success, no statistical analysis will be undertaken. The data resulting from this study will be summarized and interpreted by the Sponsor using interim assessments; in addition, a final report will be generated after all data are collected.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2013
Actual
18/04/2013
Date of last participant enrolment
Anticipated
Actual
3/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 568 0
Cairns Base Hospital - Cairns
Recruitment hospital [2] 569 0
Mona Vale Hospital - Mona Vale
Recruitment hospital [3] 570 0
Caloundra Private Hospital - Caloundra
Recruitment hospital [4] 571 0
Noosa Hospital - Noosaville
Recruitment hospital [5] 3971 0
Pittwater Day Surgery - Mona Vale
Recruitment postcode(s) [1] 6310 0
4870 - Cairns City
Recruitment postcode(s) [2] 6311 0
1660 - Mona Vale
Recruitment postcode(s) [3] 6312 0
4551 - Caloundra
Recruitment postcode(s) [4] 6313 0
4566 - Noosaville
Recruitment postcode(s) [5] 9875 0
2103 - Mona Vale

Funding & Sponsors
Funding source category [1] 286725 0
Commercial sector/Industry
Name [1] 286725 0
Medtronic Surgical Technologies
Country [1] 286725 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Australasia Pty Ltd.
Address
97 Waterloo Road
North Ryde, NSW 2113
Country
Australia
Secondary sponsor category [1] 285500 0
Commercial sector/Industry
Name [1] 285500 0
Medtronic Surgical Technologies
Address [1] 285500 0
6743 Southpoint Drive North; Jacksonville, FL 32216
Country [1] 285500 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288797 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 288797 0
Greenslopes Private Hosp
Newdegate Street
Greenslopes QLD 4120
Ethics committee country [1] 288797 0
Australia
Date submitted for ethics approval [1] 288797 0
Approval date [1] 288797 0
11/12/2012
Ethics approval number [1] 288797 0
EC00161

Summary
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.
Trial website
Trial related presentations / publications
Final Report 31/10/2014
Publications are pending
Public notes

Contacts
Principal investigator
Name 37822 0
Dr Peter Gochee, MD
Address 37822 0
Department of Surgery
Cairns Base Hospital
The Esplanade
Cairns 4870 QLD
Country 37822 0
Australia
Phone 37822 0
+61 7 42268085
Fax 37822 0
+61 7 42266519
Email 37822 0
[email protected]
Contact person for public queries
Name 37823 0
Henri Heijnen, PhD.
Address 37823 0
8 Benambra Dr.
Lower Templestowe, VIC 3107
Country 37823 0
Australia
Phone 37823 0
+61 (0) 435 771 943
Fax 37823 0
Email 37823 0
[email protected]
Contact person for scientific queries
Name 37824 0
David Hodge
Address 37824 0
6743 Southpoint Drive North
Jacksonville, FL 32216
Country 37824 0
United States of America
Phone 37824 0
+1 904 2812774
Fax 37824 0
+1 763 3674106
Email 37824 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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