InfectionNCT01105195
Efficacy of Surgical Preparations in Lumbar Spine Surgery
A study testing DuraPrep and ChloraPrep in people with Infection, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to 1) identify the common bacterial flora found on the skin overlying the lumbar spine, and 2) evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation (DuraPrep versus ChloraPrep). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- DuraPrep and ChloraPrep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing lumbar spine surgery (discectomy, laminectomy, fusion, etc).
Who cannot join
- Open wound at the incision site,
- Abrasion in the vicinity of the incision site,
- An active infection at or near the surgical site, or
- An active infection elsewhere in the body.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
The purpose of this study is to 1) identify the common bacterial flora found on the skin overlying the lumbar spine, and 2) evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation (DuraPrep versus ChloraPrep).
- Conditions
- Infection
- Being tested
- DuraPrep, ChloraPrep
- Keywords
- DuraPrep, ChloraPrep, Lumbar Spine
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraPrepOther
DuraPrep is used for skin preparation prior to surgery.
ChloraPrepOther
ChloraPrep is used for skin preparation prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| DuraPrep | Active comparator | Not described Receives: Other: DuraPrep |
| ChloraPrep | Active comparator | Not described Receives: Other: ChloraPrep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive culture results
Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105195
- Sponsor's protocol ID
- STU00008875
- Status last verified
- Nov 2010
- First submitted
- 12 Apr 2010
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
PubMed 19651954Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
PubMed 15866959
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Surgical Preparations in Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT01105195
- Acronym / sponsor ID
- STU00008875
- Conditions
- Infection
- Keywords
- DuraPrep, ChloraPrep, Lumbar Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- 3M
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 16 Apr 2010 (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.
The purpose of this study is to 1) identify the common bacterial flora found on the skin overlying the lumbar spine, and 2) evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation (DuraPrep versus ChloraPrep).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuraPrep | Active comparator | Other: DuraPrep |
| ChloraPrep | Active comparator | Other: ChloraPrep |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing lumbar spine surgery (discectomy, laminectomy, fusion, etc).
Key exclusion criteria (4 listed)
- Open wound at the incision site,
- Abrasion in the vicinity of the incision site,
- An active infection at or near the surgical site, or
- An active infection elsewhere in the body.
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 |
|---|---|---|
| DuraPrepDuraPrep is used for skin preparation prior to surgery. | Other | DuraPrep |
| ChloraPrepChloraPrep is used for skin preparation prior to surgery. | Other | ChloraPrep |
Primary outcome
Positive culture results
Time frame: 7 days
Our primary outcome measure is positive aerobic and/or anaerobic cultures reported at 7 days.
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 17 Nov 2010.
- Background: PubMed 19651954Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
- Background: PubMed 15866959Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
- Information on DuraPrepLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DuraPrep and ChloraPrep in people with Infection, run by Northwestern University at 1 site 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 1 inclusion and 4 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 17 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Positive culture results (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01105195, which also lists 2 linked publications.
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 17 Nov 2010.