Health Condition 1: K650- Generalized (acute) peritonitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of generalized peritonitis due to a hollow viscus perforation (gastroduodenal ulcer, typhoid perforation, appendicular perforation, etc.) confirmed by clinical and radiological findings. Scheduled for an emergency exploratory laparotomy with planned peritoneal lavage. Informed consent obtained (from patient or legally authorized representative if patient is incapacitated).
Exclusion criteria
Exclusion criteria: Pregnancy or lactation. Known allergy to carbapenems or any component of study solutions. Requirement for immediate re-laparotomy (e.g. known anastomotic leak) or staged surgeries (damage-control). Immunosuppression (ongoing chemotherapy, high-dose steroids, HIV with CD4 less than 200 etc.) or end-stage organ failure. Participation in another interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infection defined by CDC criteria which are purulent drainage or positive culture from incision or surgeon diagnosis of infection. This includes superficial and deep incisional infections.Timepoint: Till 30 days after the surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare SOFA 2 Scores & duration of hospital stay & mortality between groups. To evaluate the spectrum of bacterial isolates which includes multidrug resistant organisms & fungi from peritoneal fluid & drains. To assess any adverse events related to the interventions such as allergic reactions or organ dysfunction. CRP values.Timepoint: SOFA 2 scores at 0 48 & 72 hours. CRP values at 0 48 & 72 hours. | — |
Countries
India
Contacts
AIIMS NEW DELHI