Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery

Postoperative Wound Infection Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01413659
• Other study ID #: MUMS-89619
• Status: Not yet recruiting
• Phase: Phase 0
• First received: August 8, 2011
• Last updated: August 24, 2011
• Start date: September 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2011
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: IRAN : Mashhad University of Medical Sciences - Vice Chancellery of Research
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. This study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

1. Both genders

2. More than 14 years old

3. Candidate for elective colorectal surgery

Exclusion Criteria:

1. Denied written informed consent,

2. Severe neutropenia, and

3. Critically ill condition

4. Not meeting inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Postoperative Wound Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Biological:
• Symbiotic
Oral symbiotic every 8 h since 2 days before operation; Symbiotic resumes postoperatively on day +2 until day +4 for a total of 4 d of treatment (12 doses).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.		15 months	No
Secondary	The incidence of postoperative infection including surgical site infections (SSIs) and distant-site infections after elective colorectal surgery in patients whether or not receiving pre-operative symbiotic conditioning.		15 months	No