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Table 1 Diagnostic criteria of complications

From: A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part® Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group

Complication Diagnostic criteria/Definition
Impaired wound healing  
a)Delayed wound healing • Necrosis of wound edge
  • Dehiscence
b) Development of surgical site infection • Purulent secretion from the wound
  • Germ organism isolated from an aseptically obtained culture of fluid or tissue from superficial incision
  • Local signs of infection or systemic signs (fever, leukocytosis, rising CRP) without other plausible causes (e.g. pneumonia, urinary tract infection)
  • Diagnosis of an abscess in deep soft tissue (an abscess in deep soft tissue is defined as microbiological verification of suspect specimen which is generally taken by means of ultrasonic puncture)
Peritonitis • fever, leukocytosis, abdominal pain, muscular defense, absence of bowel sounds, metabolic disturbances or severe hypotension with multiple organ failure (MOF)
  Diagnosis confirmed by:
  ▪ Fluid collection by puncture or drainage
  ▪ Sonography
  ▪ Computed tomography
  ▪ Re-Intervention/Revision
Anastomosis leakage • Fever, abdominal pain, metabolic disturbances, intra-abdominal abscesses, or sepsis with multiple organ failure (MOF)
  Diagnosis confirmed by:
  ▪ Fluid collection by puncture or drainage
  ▪ Sonography
  ▪ Computed tomography
  ▪ Colonic contrast enema (water soluble contrast medium)
  ▪ Re-Intervention/Revision
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