The use of Netcell and Rapid-Rhino nasal packing after routine nasal surgery. A randomised controlled trial.

ISRCTN ISRCTN14481771
DOI https://doi.org/10.1186/ISRCTN14481771
Secondary identifying numbers N0203157782
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
12/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Steve McDonald
Scientific

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Email stevemcdonald001@hotmail.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesIn patients who have nasal surgery requiring nasal packing, which nose pack is the least uncomfortable to have removed: Netcell or Rapid-Rhino?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Nasal
InterventionPatients meeting the inclusion criteria will be recruited into a randomised controlled trial, in which one nasal cavity is packed with Netcel, and the other with Rapid-Rhino.


Patients deemed suitable will be approached for their consent to participate in the trial. A record of all such patients will be kept, along with reasons for the decline to take part if this occurs, in line with the CONSORT recommendations. All patient-sensitive data stored will be anonymous.

Randomisation
This will occur at the end of the procedure, when the surgeon decides to definitely pack both sides of the nose. If this is desired, the pack chosen for the left nostril would be selected by telephone randomisation. The pack chosen for the right nostril would be, by default, the other type of pack.

Removal of packs
As per current departmental practice, the packs will be removed by the nursing staff at 7am the following morning. Five minutes prior to removal, and immediately following removal, patients will record their pain scores on a standard 10cm visual analogue scale (an unmarked line), with the 2 ends to signify no pain and the most severe pain imaginable. Patients will mark the same line for both the left and right sides of the nose, and label each mark accordingly. The scales for the pre- and post- removal scores will be on opposite sides of a piece of paper to avoid the scores influencing one another. The left pack will always be removed first. It is possible that the order in which the packs are removed could influence the level of pain felt when the two sides are compared. Always removing the left pack first will ensure that this source of bias is eliminated.
Intervention typeProcedure/Surgery
Primary outcome measureDifference in mean Visual analogue score (VAS) on removal of pack
Secondary outcome measuresNot provided at time of registration
Overall study start date02/02/2005
Completion date02/08/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants45
Key inclusion criteriaPatients having septal surgery and trimming of inferior turbinates will be identified when they attend for pre-assessment clinic. They will be given the information about the trial at that point and given time to consider if they wish to take part before signing the consent form. Inclusion criteria will include:
1. Patients aged 16-65. Children and older adults excluded as pain responses are known to differ at extremes of age.
2. Patients undergoing septal surgery with bilateral inferior turbinate surgery. All consultants in the department routinely pack following this procedure, whereas preferences differ for other nasal operations.
This limited inclusion criterion also ensures that the same operation is carried out on each side of the nose.
Key exclusion criteria1. Revision surgery
2. History of a bleeding tendency
3. Patients on anticoagulants or anti-platelet drugs
4. History of sino-nasal trauma
5. Underlying systemic/sino-nasal disease such as Wegner's disease, sarcoidosis, fungal sinusitis
Date of first enrolment02/02/2005
Date of final enrolment02/08/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Devon & Exeter Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2009 Yes No