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


Phase 3
N/A
N/A
Not Enrolling
Both
Surgical Site Infection

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Surgical site infection

Outcome Description:

Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery

Outcome Time Frame:

30 days

Safety Issue:

Yes

Authority:

Spain: Ethics Committee

Study ID:

jruiztovar

NCT ID:

NCT01378832

Start Date:

January 2010

Completion Date:

December 2010

Related Keywords:

  • Surgical Site Infection
  • Intra-abdominal abscess
  • wound infection
  • colorectal surgery

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