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

This study has been completed.
Sponsor:
Information provided by:
Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier:
NCT01378832
First received: June 20, 2011
Last updated: June 21, 2011
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by Universidad Miguel Hernandez de Elche:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Procedure: Intra-peritoneal antibiotic lavage
    The lavage was performed immediately prior to closure of the abdominal wall. Prior to the lavage, a microbiological sample from the peritoneal surface (parietal and visceral) was obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline, similar to the one performed in Group 1. After this lavage, a new microbiological sample was obtained from the peritoneal surface (sample 2), and a second lavage with an antibiotic solution, including gentamicin (240 mg) and clindamycin (600 mg) dissolved in 500 ml normal saline was performed. During this lavage, the solution was allowed to sit in the abdominal cavity for 3 minutes. After aspirating the lavage, a third microbiological sample was obtained in the same way as the two previous ones (sample 3).
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  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