Condition category
Ear, Nose and Throat
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Tristram Hugh John Lesser

ORCID ID

Contact details

Otolaryngology
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes