Closed or Open Abdomen for the Management of Abdominal Sepsis
Abdominal Sepsis | Abdominal InfectionThis is a prospective randomized clinical study. The study will comprise the randomized decision to either A) primarily close the fascia after laparotomy for intra-abdominal infection (CLOSED); or B) leave the fascia open after laparotomy and apply a temporary abdominal closure (TAC) device (OPEN) with a vacuum drain.
Although debatable, both procedures (CLOSED or OPEN abdomen) are acceptable based on current suggested standard of care. Thus, high quality data to direct clinical decision making in this highly lethal condition is urgently required.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* Presence of purulent, feculent, or enteric spillage over at least 2 intra-peritoneal quadrants intra-operatively;
* Septic shock, or
* Predisposition-Infection-Response-Organ Dysfunction Score \> 3, or
* World-Society-of-Emergency-Surgery-Sepsis-Severity-Score \> 8
Exclusion Criteria:
* Pregnant;
* Confirmed or strongly suspected severe IAH (IAP\>20 mmHg);
* No intentional of providing ongoing care;
* pancreatitis as the source of peritonitis;
* uncontrolled bleeding
Lieu de l'étude
Foothills Medical Centre
Foothills Medical CentreCalgary, Alberta
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- University of Calgary
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT03163095