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Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery

Information source: Universidad Miguel Hernandez de Elche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgical Site Infection

Intervention: Intra-peritoneal antibiotic lavage (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Universidad Miguel Hernandez de Elche

Summary

Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.

Clinical Details

Official title: Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Surgical site infection

Detailed description: A prospective, randomized study was performed between January and December 2010. Patient inclusion criteria were a diagnosis of colorectal neoplasms and plans to undergo an elective curative surgery. Patients were divided into 2 groups: Group 1 (intra-abdominal irrigation with normal saline) and Group 2 (intraperitoneal irrigation with a solution of 240 mg gentamicin and 600 mg clindamycin). The occurrence of wound infections and intra-abdominal abscesses were investigated. Following the anastomosis, a microbiological sample of the peritoneal surface was obtained (sample 1). A second sample was collected following an irrigation with normal saline (sample 2). Finally, the peritoneal cavity was irrigated with a gentamicin-clindamycin solution and a third sample was obtained (sample 3).

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- diagnosis of colorectal neoplasms and plans to undergo an elective surgery with

curative aims. Exclusion Criteria:

- preoperative diagnosis of chronic renal failure, because of the risk of

nephrotoxicity associated with intraperitoneal gentamicin absorption

- an anastomotic leak in the postoperative course

Locations and Contacts

Additional Information

Starting date: January 2010
Last updated: June 21, 2011

Page last updated: August 23, 2015

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