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Table 1 Time schedule of enrolment, interventions and assessments

From: A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial

TIMEPOINT

Baseline

Day of surgery

Follow up

 

-t1

0

Day 1

2 wk

6 wk

3 m

6 m

12 months

ENROLMENT:

 Eligibility screen

X

       

 Informed consent

X

       

Demographics

X

       

 Randomization

 

X

      

INTERVENTIONS:

 Conventional wound closure

 

X

      

 Flap fixation using sutures

 

X

      

 Flap fixation using tissue glue

 

X

      

ASSESSMENTS:

 Clinical assessment seroma and complications

   

X

X

X

X

X

 Pain score

   

X

X

X

X

X

 Patient reported cosmesis assessment

   

X

X

X

X

X

 DASH

X

  

X

X

X

X

X

 EQ-5D

X

   

X

X

X

X

 Cost evaluation

X

 

X

  

X

X

X