Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery (lavage)
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Purpose
Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.
| Condition | Intervention | Phase |
|---|---|---|
|
Surgical Site Infection |
Procedure: Intra-peritoneal antibiotic lavage |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery |
- Surgical site infection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery
| Enrollment: | 102 |
| Study Start Date: | January 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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Procedure: Intra-peritoneal antibiotic lavage
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided by Universidad Miguel Hernandez de Elche
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jaime Ruiz-Tovar, Universidad Miguel Hernandez de Elche |
| ClinicalTrials.gov Identifier: | NCT01378832 History of Changes |
| Other Study ID Numbers: | jruiztovar |
| Study First Received: | June 20, 2011 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Universidad Miguel Hernandez de Elche:
|
Intra-abdominal abscess wound infection colorectal surgery |
Additional relevant MeSH terms:
|
Anti-Bacterial Agents Clindamycin Clindamycin-2-phosphate Gentamicins Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013