Head and neck cancer Cancer Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissues
Conditions
Interventions
Randomisation lists shall be produced by a statistician at the NWSTC prior to the recruitment of the first patient. Patients shall be randomised using a 1:1 ratio. Lists shall be produced based on the
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients due to undergo lateral neck dissection 2. Neck dissection to include a minimum of 3 levels 3. Patients who have capacity to consent
Exclusion criteria
Exclusion criteria: 1. Known allergy to Aprotinin (an ingredient of Fibrin Sealants known to cause allergic reactions) 2. Pregnancy or breastfeeding 3. Age less than 18 years 4. Bilateral neck dissection 5. Previous exposure to Fibrin Sealant within the last 6 months 6. The patient has a cancer that requires complex reconstructive surgery 7. Allergy to dairy products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this research is a 'pilot study' no formal primary outcome measure has been specified. The outcomes measures for this study can be divided into those that will inform the pilot study and those that will inform the future 'full' clinical trial. 1. Proportion of eligible patients recruited to the study, calculated as the screened to randomisation rate at 12 months at the end of the DEFeND study 2. Reasons for failure to screen potentially eligible patients. Qualitative data recorded as free text for every patient who was potentially eligible but was not screened recorded at screening 3. Recruitment rate measured as the number of patients randomised each month throughout the study for 12 months 4. Reasons for failure to randomise. Qualitative data recorded as free text for every patient who was recruited but not randomised recorded at baseline 5. Reasons for failure to reveal allocation at a specific time point during surgery. Qualitative data recorded as free text for every patient who was randomised but did not have their allocation revealed at the correct timepoint during surgery. This is recorded on the day of surgery 6. Fidelity of the blinding process (both patients and outcome assessors) as detected by blinding indices. This is assessed by asking the patient and research team members what the allocation for that particular patient when they exit the study at follow-up 2 (day 28 – 42) or premature discontinuation 7. Accuracy of data recording, summarised by the number of key data items with missing/incomplete data entries recorded per patient when they exit the study at follow-up 2 (day 28 – 42) or premature discontinuation 8. Number of patients lost to follow-up recorded at 12 months at the end of the DEFeND study 9. Protocol adherence, measured by the number of major/minor protocol deviations observed per patient when they exit the study at follow-up 2 (day 28 – 42) or premature discontinuation 10. The minimal clinically important difference (MCID) in clin | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surgical complications recorded using the Clavien-Dindo classification of surgical complications recorded every day of in-patient stay, follow-ups 1 and 2, any unscheduled follow-up and at premature discontinuation 2. Wound drainage volume (ml) recorded 2 – 3 times daily during inpatient stay while surgical drain is in situ 3. Time (hours) for wound drainage volume to reach a rate of <30ml/24hrs (<1.25ml/hr) from the end of surgery. Recorded during inpatient stay 4. Time (hours) to drain removal (as dictated by drainage volume) from end of surgery. Recorded during inpatient stay 5. Total wound drainage volume (ml) from the time of drain activation to drain removal. Recorded during inpatient stay 6. Time (hours) to be declared medically fit for hospital discharge and time (hours) to actual hospital discharge. Recorded during inpatient stay 7. Incremental cost-effectiveness ratio, calculated per patient when they exit the study at follow-up 2 (day 28 – 42) or premature discontinuation 8. Neck Dissection Impairment Index (NDII). This is a procedure specific validated patient reported outcome measure. Recorded at baseline and when they exit the study at follow-up 2 (day 28 – 42) or premature discontinuation 9. Daily patient reported pain score using Visual Analogue Scale (VAS) recorded at baseline, every day of in-patient stay, follow-ups 1 and 2, any unscheduled follow-up and at premature discontinuation | — |
Countries
England, United Kingdom
Outcome results
None listed