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
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
| stevemcdonald001@hotmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | In 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) studied | Surgery: Nasal |
| Intervention | Patients 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 type | Procedure/Surgery |
| Primary outcome measure | Difference in mean Visual analogue score (VAS) on removal of pack |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/02/2005 |
| Completion date | 02/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 45 |
| Key inclusion criteria | Patients 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 criteria | 1. 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 enrolment | 02/02/2005 |
| Date of final enrolment | 02/08/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
