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Table 2 Flow Chart ISSAAC Trial

From: A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]

 

Visit 1

(Screening)

Visit 2

(day 0)

Visit 3

(day 2 ± 1)

Visit 4

(day of discharge

or the day before)

Visit 5

(day 30 ± 5)

Visit 6

(12 ± 1 months

post surgery)

Informed consent

X

     

Demographic data*

X

     

BMI

X

     

Smoker/non-smoker

X

     

Inclusion/exclusion

X

     

Medical history

X

     

Physical examination

X

 

X1)

X1)

X1)

X2)

Reason for surgery

X

     

Surgery

 

X

    

Board certified surgeon

 

X

    

Deviations from surgical procedure as described in protocol

 

X

    

Ultrasound of the abdominal wall

     

X

Abdominal Adverse Event/Serious Adverse Event

 

X

X

X

X

X

Re-operation due to burst abdomen necessary?

  

X

X

X

X

Wound infection

  

X

X

X

 

discharge

   

X

  
  1. 1) of the abdomen and the laparotomy wound
  2. 2) of the abdomen
  3. * date of birth, gender, weight, height
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