Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01413659
Other study ID # MUMS-89619
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT00290290 - Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Phase 3
Completed NCT00287599 - Rapid Identification of Key Pathogens in Wound Infection by Molecular Means N/A
Completed NCT03574090 - Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery Phase 4
Completed NCT01212315 - Effects of Triclosan-coated Sutures in Cardiac Surgery Phase 4
Completed NCT03174223 - Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates
Withdrawn NCT01691352 - Wick vs. No Wick: Does Method of Closure Affect Rate of Wound Infection? N/A
Completed NCT01089712 - Management Practices and the Risk of Infection Following Cardiac Surgery N/A
Completed NCT00484055 - Local Collagen-Gentamicin and Extra Fixation of the Sternum for Prevention of Sternal Wound Infection in Cardiac Surgery N/A
Completed NCT00987402 - Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation Phase 1/Phase 2
Completed NCT04088162 - The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery N/A
Recruiting NCT04725916 - Studying How Outpatient Water affEcts Risks With Drains (SHOWER Study) N/A
Completed NCT00906074 - Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery N/A
Not yet recruiting NCT01184430 - Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery N/A