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NCT02490631 · ClinicalTrials.gov registry record · Phase 3
2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients
A Phase 3 study of Surgical Site Infections and Post Operative Complication, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
- 1
- Study location
NCT02490631: Completed Phase 3 study of Surgical Site Infections and Post Operative Complication, sponsored by Vanderbilt University.
NCT02490631 is a Phase 3 study of Surgical Site Infections and Post Operative Complication that has completed, run by Vanderbilt University. The registered enrollment target is 158 participants, below the 1,834-participant average among 3 other Surgical Site Infections trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02490631, a Phase 3 study of Surgical Site Infections and Post Operative Complication, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
- 1
- Study location
Study Summary
Surgical site infection (SSI) following spinal surgery is a frequent complication and results in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients and result in higher postoperative morbidity, mortality and health care costs. Vanderbilt University Medical Center SSI rate is 7%. Treatment for SSI can be challenging often requiring revision surgery, long-term antibiotics, and prolonged hospitalization. The accurate identification of risk factors is thus important in the development of strategies to prevent these potentially devastating infections. This study proposes a randomized, controlled trial of neuro-spine patients of 2% chlorhexidine gluconate skin preparation cloths for the prevention of post op surgical site infections in spine patients. Use of CHG cloths the night before and morning of surgery (neckline to toes) will affect (decrease rates) of SSI compared to patients who receive routine standard of care (soap and water pre-op, day of surgery and daily post-operative).
Primary Outcome
Evaluation daily using the CDC guidelines, daily measurements and deidentified photos
Conditions Studied
Interventions
- DRUG 2% chlorhexidine gluconate cloths
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2015-08 |
| Est. Completion | 2018-12-31 |
| Phase | Phase 3 |
What the finished NCT02490631 record still lists
NCT02490631 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 1,834-participant average among 3 other Surgical Site Infections trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Surgical Site Infections appearing as the primary indexed condition, and to 1 intervention - of which 2% chlorhexidine gluconate cloths is the first listed.
NCT02490631 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02490631 about?
NCT02490631 is a clinical study titled "2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients". Surgical site infection (SSI) following spinal surgery is a frequent complication and results in higher morbidity, mortality and healthcare costs. SSI following adult spinal surgery is a frequent complication that has been reported to occur in 0.7-12.0% of patients and result in higher postoperative...
What is the current status of trial NCT02490631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2015-08. Estimated completion is 2018-12-31.
What conditions does trial NCT02490631 study?
This clinical trial studies the following conditions: Surgical Site Infections, Post Operative Complication.
What interventions are being tested in trial NCT02490631?
The interventions under investigation include: 2% chlorhexidine gluconate cloths (DRUG).
Who is sponsoring clinical trial NCT02490631?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02490631 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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