Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0025107235
Study information
Scientific title
The effect of post-operative nasal packing on mucociliary activity
Acronym
Study hypothesis
We expect that nasal packs disrupt the nasal mucosal membrane for up to 3 months causing increased morbidity.
Ethics approval
Not provided at time of registration
Study design
Prospective randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ear, Nose and Throat: Post-operative nasal packing
Intervention
Patients will be randomised to receive either Merocel, Vasolene gauze or no packs. The effect on the mucociliary transport will be assessed by performing a saccharin clearance test pre-operatively, after removal of packs prior to discharge and at subsequent clinic follow-up. It is envisaged that the packs will significantly alter the mucociliary transport time, leading to increased post-operative morbidity. This will lead to an alteration in departmental policy and fewer patients will be packed as a result. Data analysis of the results to assess the mucociliary transport rates will be done.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2001
Overall trial end date
01/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40 ENT patients
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2001
Recruitment end date
01/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital Aintree
Liverpool
L9 7AL
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Aintree Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary