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Table 1 Schedule of assessments (SPIRIT figure)

From: Determining the effectiveness of fibrin sealants in reducing complications in patients undergoing lateral neck dissection (DEFeND): study protocol for a randomised external pilot trial

ProceduresHead and Neck Clinic/MDTScreeningPre-operative assessmentBaseline*Day of surgery (day 0)Follow-up schedulePremature discontinuation
Daily in-patient assessmentFollow-up 1 (days 7–14)Follow-up unscheduledFollow-up 2 (days 28–42)
Identify potential participantXX        
Approach potential participant to discuss studyXX        
Medical history X        
Physical examination X        
Assessment of eligibility criteria X        
Review of concomitant anticoagulant medications XXXXXXXXX
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 XXXXX
 Neck Dissection Impairment Index (NDII)   X    XX
 Wound Healing Questionnaire (WHQ)        XX
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)    XXXXXX
 Wound drainage volume (ml)     X    
 Wound drain removal     X    
 Hospital discharge     X    
Assessment of pilot study outcomes
 Assessment of blinding strategy        XX
 Assessment of minimal clinically important Difference        XX
Laboratory tests
 Full blood count**   X      
 INR & APTT   X      
 Pregnancy test (women of childbearing age)   X      
 Histological lymph node yield        X 
  1. VAS visual analogue scale, INR international normalized ratio, APTT activated partial thromboplastin time
  2. *At baseline, all procedures should be done before study intervention
  3. **Full Blood Count must include haemoglobin concentration, platelet count and white cell count
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Pilot and Feasibility Studies

ISSN: 2055-5784