Postoperative Wound Infection Clinical Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mashhad University of Medical Sciences |
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 |
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