Table 1 Schedule of assessments (SPIRIT figure)
Procedures | Head and Neck Clinic/MDT | Screening | Pre-operative assessment | Baseline* | Day of surgery (day 0) | Follow-up schedule | Premature discontinuation | |||
|---|---|---|---|---|---|---|---|---|---|---|
Daily in-patient assessment | Follow-up 1 (days 7–14) | Follow-up unscheduled | Follow-up 2 (days 28–42) | |||||||
Identify potential participant | X | X | ||||||||
Approach potential participant to discuss study | X | X | ||||||||
Medical history | X | |||||||||
Physical examination | X | |||||||||
Assessment of eligibility criteria | X | |||||||||
Review of concomitant anticoagulant medications | X | X | X | X | X | X | X | X | X | |
Review of previous treatment to the ipsilateral neck | X | |||||||||
Demographic assessment | X | |||||||||
Signed consent form | X | |||||||||
Randomisation | X | |||||||||
Assessment of patient-reported outcome measures | ||||||||||
Neck pain (VAS) | X | X | X | X | X | X | ||||
Neck Dissection Impairment Index (NDII) | X | X | X | |||||||
Wound Healing Questionnaire (WHQ) | X | X | ||||||||
Surgical protocol | ||||||||||
Neck dissection surgery | X | |||||||||
Allocation revealed at point of wound closure | X | |||||||||
Prepare and administer ARTISS (interventional arm only) | X | |||||||||
Assessment of clinical outcome measures | ||||||||||
Assessment of AEs (Clavien-Dindo) | X | X | X | X | X | X | ||||
Wound drainage volume (ml) | X | |||||||||
Wound drain removal | X | |||||||||
Hospital discharge | X | |||||||||
Assessment of pilot study outcomes | ||||||||||
Assessment of blinding strategy | X | X | ||||||||
Assessment of minimal clinically important Difference | X | X | ||||||||
Laboratory tests | ||||||||||
Full blood count** | X | |||||||||
INR & APTT | X | |||||||||
Pregnancy test (women of childbearing age) | X | |||||||||
Histological lymph node yield | X | |||||||||