Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis.

ABSTRACT:

Background

Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study (https://clinicaltrials.gov/ct2/show/NCT03163095) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS.

Main body

Research in critically ill incapacitated patien

SUBMITTER: Doig CJ 

PROVIDER: S-EPMC6683332 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature