Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT01764750
Eligibility Criteria:
Inclusion Criteria:
1. Posterior instrumented spinal surgery patients 18 years of age and older with instrumented fusion of at least three vertebral levels
1. Revision, elderly, obese, and diabetic patients will not be excluded since these patients are known to be at higher risk of wound infection and represent an important fraction of the elective surgical patient population.
2. Patients requiring IV Vancomycin for infection prophylaxis (i.e. due to cephalosporin allergy) will be eligible for participation in the IV Vancomycin group.
Exclusion Criteria:
Intrasite Vancomycin Study Arm Exclusion Criteria
1. Children under 18 years old
2. Patients not receiving instrumentation or having less than three segment surgery
\- therefore having small wound bed surface areas, close operative quarters, and lower infection risk.
3. Patients not receiving wound drains
* drains provide the conduit for seroma fluid collection
4. Patients with known or suspected current infection
5. Use of systemic or topical antibiotics within 72 hours prior to surgery
* other than standard pre-op dose of ancef
6. Use of drugs or medications known to significantly increase the risk of renal toxicity within the perioperative period.
7. Patients with known significant allergy to Vancomycin
\- Redman Syndrome patients will not be excluded
8. Use of IV Vancomycin for perioperative infection prophylaxis (for example, in cases of penicillin/cephalosporin allergy) will exclude patients from participation in the intrasite Vancomycin groups of the study.
* IV Vancomycin Study Arm Exclusion Criteria
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1. Children under 18 years old
2. Patients not receiving instrumentation or having less than three segment surgery - therefore having small wound bed surface areas, close operative quarters, and lower infection risk.
3. Patients not receiving wound drains
\- drains provide the conduit for seroma fluid collection
4. Patients with known or suspected current infection
5. Use of systemic or topical antibiotics within 72 hours prior to surgery
* other than study related IV Vancomycin
6. Use of drugs or medications known to significantly increase the risk of renal toxicity within the perioperative period.
7. Patients with known significant allergy to Vancomycin
* Redman Syndrome patients will not be excluded
8. Use of intrasite Vancomycin for infection prophylaxis will exclude patients from participation in the IV Vancomycin study group.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01764750
Study Brief:
Protocol Section:
NCT01764750