InfectionNCT02891486
Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery
An observational study of Infection, run by University of Miami at 2 sites in United States.
Trial summary
Post-operative wound infections can prolong hospital stays, increase rates of readmission to the intensive care unit, and increase the costs of treatment significantly. This study will conduct a prospective chart review of all patients undergoing elective spinal surgery on both the neurosurgery and orthopedic spine… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Spinal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 6,959 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients 18 years of age or older undergoing a spinal operation.
Who may be able to join
- 18 years of age or older
- Patients undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services
- Patients who develop post-operative wound infections within 90 days of surgery
Who cannot join
- Patients younger than 18 years of age
- Patients who are not undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services
- Patients who do not develop post-operative wound infections within 90 days of surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jackson Memorial Hospital
Miami, Florida, 33136
University of Miami Hospital
Miami, Florida, 33136
About this study
Official title: Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery - a Prospective Study
Post-operative wound infections can prolong hospital stays, increase rates of readmission to the intensive care unit, and increase the costs of treatment significantly. This study will conduct a prospective chart review of all patients undergoing elective spinal surgery on both the neurosurgery and orthopedic spine services at two facilities on an academic campus. The investigators will collect the data of those patients who develop post-surgical infections. This data will then be analyzed and compared to published data from other studies. The aim of this investigation is to passively collect this infection data, which may ultimately provide needed baseline incidence rates using current and standard protocols.
Read the detailed description
This is a chart review study.
- Conditions
- Infection
- Being tested
- Spinal surgery
- Keywords
- spinal surgery, surgical site infection
- Medical subject headings
- Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal surgeryProcedure or surgery
Elective spinal surgery performed
| Study group | Role | What they receive |
|---|---|---|
| Incidence of surgical site infection | The number of spinal surgery patients with surgical site infections. Receives: Procedure: Spinal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who develop a surgical site infection (SSI)
Spinal reoperation at the same surgical location for incision, debridement and irrigation
Measured: 90 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJun 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,959 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan D. Levi, MD, PhD, University of Miami
- Investigators
- Allan D Levi, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891486
- Sponsor's protocol ID
- 20110185
- Status last verified
- Feb 2017
- First submitted
- 1 Sep 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery - a Prospective Study
- ClinicalTrials.gov ID
- NCT02891486
- Acronym / sponsor ID
- 20110185
- Conditions
- Infection
- Keywords
- spinal surgery, surgical site infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,959 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-operative wound infections can prolong hospital stays, increase rates of readmission to the intensive care unit, and increase the costs of treatment significantly. This study will conduct a prospective chart review of all patients undergoing elective spinal surgery on both the neurosurgery and orthopedic spine services at two facilities on an academic campus. The investigators will collect the data of those patients who develop post-surgical infections. This data will then be analyzed and compared to published data from other studies. The aim of this investigation is to passively collect this infection data, which may ultimately provide needed baseline incidence rates using current and standard protocols.
Detailed description
This is a chart review study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incidence of surgical site infection | – | Procedure: Spinal surgeryThe number of spinal surgery patients with surgical site infections. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or older undergoing a spinal operation.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patients undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services
- Patients who develop post-operative wound infections within 90 days of surgery
Key exclusion criteria (3 listed)
- Patients younger than 18 years of age
- Patients who are not undergoing elective spinal surgery on either the neurosurgery and orthopedic spine services
- Patients who do not develop post-operative wound infections within 90 days of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal surgeryElective spinal surgery performed | Procedure or surgery | Incidence of surgical site infection |
Primary outcome
Number of patients who develop a surgical site infection (SSI)
Time frame: 90 days following surgery
Spinal reoperation at the same surgical location for incision, debridement and irrigation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan D Levi, MD, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who develop a surgical site infection (SSI) (time frame: 90 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.