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

Surgical Site Infection Clinical Trial

— lavage  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378832
• Other study ID #: jruiztovar
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2011
• Last updated: June 21, 2011
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2010
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery	30 days	Yes