Wound InfectionPhase 4NCT01977989
Vancomycin in Spine Surgery
A Phase 4 study testing Vancomycin Powder in people with Wound Infection, run by University of Tennessee at 1 site in United States.
Trial summary
The purpose of this study is to study how well using a powdered form of the antibiotic, vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented spinal surgery for traumatic injury to the back. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Infection
- What is being tested?
- Vancomycin Powder
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 4
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hemodynamically stable
- 18 years of age or older
- Undergoing spinal fusion for traumatic cervical, thoracic, or lumbar injury
Who cannot join
- Septic patient
- Open or penetrating spinal injury
- Active infection
- Active cancer
- Known allergy to vancomycin
- Previous surgery in surgical site
- History of radiation therapy at surgical site
- Immunosuppressed (disease or drug-induced)
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Medical Center (The MED)
Memphis, Tennessee, 38103
About this study
Official title: Randomized Control Trial of Vancomycin Powder Following Posterior Instrumented Spinal Surgery for Trauma
The purpose of this study is to study how well using a powdered form of the antibiotic, vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented spinal surgery for traumatic injury to the back.
Vancomycin is approved by the United States Food and Drug Administration (FDA) for treating certain kinds of bacteria. It is also used to prevent infections of the surgery site.
Read more
This will be a study in which the experimental treatment is compared to a standard (control) treatment. It will be prospective in nature, meaning that it will follow patients forward in time, and it will consist of a randomization process to determine who will receive the experimental treatment versus the standard (control) treatment.
The study will take place at Regional Medical Center (The MED). 140 subjects will be participating in this study.
The investigators hypothesize that the topical use of powder vancomycin will decrease the rate of surgical site infection.
Read the detailed description
- Purpose: The purpose of this study is to examine the efficacy of prophylactic, locally applied vancomycin powder against surgical site infection in patients undergoing posterior instrumented spinal surgery for traumatic injury.
- Rationale: Surgical site infection (SSI) is a morbid complication with high cost in management of surgical spine patients. In this era of healthcare reforms, adjuvant therapies that not only improve quality, but also decrease cost, are considered of highest value. Despite the use of prophylactic systemic antibiotics and improved surgical technique, surgical site infections remain a serious perioperative concern. In comparison to systemic antibiotics, local delivery of antibiotics is attractive because high concentrations are achieved directly at these sites and systemic toxicity is limited. Prior investigations have primarily focused on the treatment of infected wounds with local antibiotics. Only a few studies have analyzed prophylactic use of local antibiotics during spine surgery. To date, there are no prospective, randomized studies on the prophylactic use of local antibiotics. The investigators will introduce local vancomycin powder into their practice of instrumented posterior spinal fusion for traumatic spine injury and determine efficacy in preventing postoperative infections.
- Study Population: The study will consist of adult patients undergoing posterior, instrumented spine surgery for traumatic injury.
- Research Design: This will be a prospective, randomized, controlled trial. The study will primarily be carried out through the University of Tennessee Health Science Center with all spinal surgery taking place at the Regional Medical Center at Memphis. Once patients with traumatic spine injury have been deemed eligible through several other criteria described later in the application, they will be placed into one of two randomized groups:
- The control group will consist of patients who are administered systemic prophylactic antibiotic only.
- The treatment group will consist of patients who are administered systemic prophylactic antibiotic along with vancomycin powder within the surgical site.
- Study/Project Procedures: Patients who meet the entry criteria and agree to participate in the trial will be randomized to receive intraoperative vancomycin powder within the surgical wound or not. In all patients, vancomycin 1g and cefazolin 2g IV will be given within 60min of skin incision. If an allergy to cefazolin exists, 900mg of clindamycin IV will be used in its place. Cefazolin 1g IV will be given q6hr during surgery and continued q8hr post surgery for 24hrs, regardless of whether a surgical drain is in place. One to three liters of normal saline will be used for irrigation purposes during surgical procedure. Prior to wound closure, vancomycin powder will be topically applied both above (50% of dose) and below (50% of dose) the deep muscular fascia in patients participating in the treatment arm of the study. For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin (1/2 vial) will be applied. For surgeries involving greater than 3 contiguous spinal segments, 1gm will be applied.
- Outcome Measures: All patients will be followed on an inpatient or outpatient basis (as applicable) for a period of 12 months post-operatively. Residents, attendings and study coordinators will perform data collection. All patients with suspected wound infection will undergo MRI with contrast for verification, unless there is gross evidence of infection (ex. purulent drainage from the incision, erythema and swelling). A CT scan with contrast will be obtained in those patients who are unable to undergo MRI for various reasons (pacemaker, metallic foreign bodies, fresh vascular stents, etc.). All wound data will be collected and recorded in specific data forms at each clinical encounter.
- Conditions
- Wound Infection
- Being tested
- Vancomycin Powder
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin PowderDrug
For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin will be applied topically. For surgeries involving more than 3 contiguous spinal segments, 1gm of vancomycin will be applied topically to the surgical site.
| Study group | Role | What they receive |
|---|---|---|
| No Vancomycin Powder | No intervention | Patients who only receive IV Vancomycion prior to surgery. No Vancomycin powder is administered. |
| Vancomycin Powder | Active comparator | Patients who receive Vancomycin powder in the surgical site following surgery. Receives: Drug: Vancomycin Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
All patients with suspected wound infection will undergo MRI with contrast for verification, unless there is gross evidence of infection. A CT scan with contrast will be obtained in those patients who are unable to undergo MRI for various reasons.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Semmes-Murphey Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977989
- Sponsor's protocol ID
- 13-02478-FB
- Status last verified
- Oct 2013
- First submitted
- 31 Oct 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
PubMed 12603990Bibbo C, Patel DV. The effect of demineralized bone matrix-calcium sulfate with vancomycin on calcaneal fracture healing and infection rates: a prospective study. Foot Ankle Int. 2006 Jul;27(7):487-93. doi: 10.1177/107110070602700702.
PubMed 16842714Branstetter JG, Jackson SR, Haggard WO, Richelsoph KC, Wenke JC. Locally-administered antibiotics in wounds in a limb. J Bone Joint Surg Br. 2009 Aug;91(8):1106-9. doi: 10.1302/0301-620X.91B8.22216.
PubMed 19651846Buchholz HW, Engelbrecht H. [Depot effects of various antibiotics mixed with Palacos resins]. Chirurg. 1970 Nov;41(11):511-5. No abstract available. German.
PubMed 5487941Calderone RR, Garland DE, Capen DA, Oster H. Cost of medical care for postoperative spinal infections. Orthop Clin North Am. 1996 Jan;27(1):171-82.
PubMed 8539047Burdon DW. Principles of antimicrobial prophylaxis. World J Surg. 1982 May;6(3):262-7. doi: 10.1007/BF01653540. No abstract available.
PubMed 7113232Cavanaugh DL, Berry J, Yarboro SR, Dahners LE. Better prophylaxis against surgical site infection with local as well as systemic antibiotics. An in vivo study. J Bone Joint Surg Am. 2009 Aug;91(8):1907-12. doi: 10.2106/JBJS.G.01237.
PubMed 19651948Dahners LE, Funderburk CH. Gentamicin-loaded plaster of Paris as a treatment of experimental osteomyelitis in rabbits. Clin Orthop Relat Res. 1987 Jun;(219):278-82.
PubMed 3581579Edin ML, Miclau T, Lester GE, Lindsey RW, Dahners LE. Effect of cefazolin and vancomycin on osteoblasts in vitro. Clin Orthop Relat Res. 1996 Dec;(333):245-51.
PubMed 8981903Gitelis S, Brebach GT. The treatment of chronic osteomyelitis with a biodegradable antibiotic-impregnated implant. J Orthop Surg (Hong Kong). 2002 Jun;10(1):53-60. doi: 10.1177/230949900201000110.
PubMed 12401922Glassman SD, Dimar JR, Puno RM, Johnson JR. Salvage of instrumental lumbar fusions complicated by surgical wound infection. Spine (Phila Pa 1976). 1996 Sep 15;21(18):2163-9. doi: 10.1097/00007632-199609150-00021.
PubMed 8893444Gold HS, Moellering RC Jr. Antimicrobial-drug resistance. N Engl J Med. 1996 Nov 7;335(19):1445-53. doi: 10.1056/NEJM199611073351907. No abstract available.
PubMed 8875923Isefuku S, Joyner CJ, Simpson AH. Gentamicin may have an adverse effect on osteogenesis. J Orthop Trauma. 2003 Mar;17(3):212-6. doi: 10.1097/00005131-200303000-00010.
PubMed 12621263Isefuku S, Joyner CJ, Simpson AH. Toxic effect of rifampicin on human osteoblast-like cells. J Orthop Res. 2001 Sep;19(5):950-4. doi: 10.1016/S0736-0266(01)00022-5.
PubMed 11562146Klemm KW. Antibiotic bead chains. Clin Orthop Relat Res. 1993 Oct;(295):63-76.
PubMed 8403672
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Vancomycin Powder Following Posterior Instrumented Spinal Surgery for Trauma
- ClinicalTrials.gov ID
- NCT01977989
- Acronym / sponsor ID
- 13-02478-FB
- Conditions
- Wound Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Semmes-Murphey Foundation
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 7 Nov 2013 (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 study how well using a powdered form of the antibiotic, vancomycin, inside the surgery wound prevents infection in patients undergoing instrumented spinal surgery for traumatic injury to the back.
Vancomycin is approved by the United States Food and Drug Administration (FDA) for treating certain kinds of bacteria. It is also used to prevent infections of the surgery site.
This will be a study in which the experimental treatment is compared to a standard (control) treatment. It will be prospective in nature, meaning that it will follow patients forward in time, and it will consist of a randomization process to determine who will receive the experimental treatment versus the standard (control) treatment.
The study will take place at Regional Medical Center (The MED). 140 subjects will be participating in this study.
The investigators hypothesize that the topical use of powder vancomycin will decrease the rate of surgical site infection.
Detailed description
- Purpose: The purpose of this study is to examine the efficacy of prophylactic, locally applied vancomycin powder against surgical site infection in patients undergoing posterior instrumented spinal surgery for traumatic injury.
- Rationale: Surgical site infection (SSI) is a morbid complication with high cost in management of surgical spine patients. In this era of healthcare reforms, adjuvant therapies that not only improve quality, but also decrease cost, are considered of highest value. Despite the use of prophylactic systemic antibiotics and improved surgical technique, surgical site infections remain a serious perioperative concern. In comparison to systemic antibiotics, local delivery of antibiotics is attractive because high concentrations are achieved directly at these sites and systemic toxicity is limited. Prior investigations have primarily focused on the treatment of infected wounds with local antibiotics. Only a few studies have analyzed prophylactic use of local antibiotics during spine surgery. To date, there are no prospective, randomized studies on the prophylactic use of local antibiotics. The investigators will introduce local vancomycin powder into their practice of instrumented posterior spinal fusion for traumatic spine injury and determine efficacy in preventing postoperative infections.
- Study Population: The study will consist of adult patients undergoing posterior, instrumented spine surgery for traumatic injury.
- Research Design: This will be a prospective, randomized, controlled trial. The study will primarily be carried out through the University of Tennessee Health Science Center with all spinal surgery taking place at the Regional Medical Center at Memphis. Once patients with traumatic spine injury have been deemed eligible through several other criteria described later in the application, they will be placed into one of two randomized groups:
- The control group will consist of patients who are administered systemic prophylactic antibiotic only.
- The treatment group will consist of patients who are administered systemic prophylactic antibiotic along with vancomycin powder within the surgical site.
- Study/Project Procedures: Patients who meet the entry criteria and agree to participate in the trial will be randomized to receive intraoperative vancomycin powder within the surgical wound or not. In all patients, vancomycin 1g and cefazolin 2g IV will be given within 60min of skin incision. If an allergy to cefazolin exists, 900mg of clindamycin IV will be used in its place. Cefazolin 1g IV will be given q6hr during surgery and continued q8hr post surgery for 24hrs, regardless of whether a surgical drain is in place. One to three liters of normal saline will be used for irrigation purposes during surgical procedure. Prior to wound closure, vancomycin powder will be topically applied both above (50% of dose) and below (50% of dose) the deep muscular fascia in patients participating in the treatment arm of the study. For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin (1/2 vial) will be applied. For surgeries involving greater than 3 contiguous spinal segments, 1gm will be applied.
- Outcome Measures: All patients will be followed on an inpatient or outpatient basis (as applicable) for a period of 12 months post-operatively. Residents, attendings and study coordinators will perform data collection. All patients with suspected wound infection will undergo MRI with contrast for verification, unless there is gross evidence of infection (ex. purulent drainage from the incision, erythema and swelling). A CT scan with contrast will be obtained in those patients who are unable to undergo MRI for various reasons (pacemaker, metallic foreign bodies, fresh vascular stents, etc.). All wound data will be collected and recorded in specific data forms at each clinical encounter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Vancomycin Powder | No intervention | –Patients who only receive IV Vancomycion prior to surgery. No Vancomycin powder is administered. |
| Vancomycin Powder | Active comparator | Drug: Vancomycin PowderPatients who receive Vancomycin powder in the surgical site following surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hemodynamically stable
- 18 years of age or older
- Undergoing spinal fusion for traumatic cervical, thoracic, or lumbar injury
Key exclusion criteria (8 listed)
- Septic patient
- Open or penetrating spinal injury
- Active infection
- Active cancer
- Known allergy to vancomycin
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 |
|---|---|---|
| Vancomycin PowderFor surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin will be applied topically. For surgeries involving more than 3 contiguous spinal segments, 1gm of vancomycin will be applied topically to the surgical site. | Drug | Vancomycin Powder |
Primary outcome
Surgical Site Infection
Time frame: 12 Months
All patients with suspected wound infection will undergo MRI with contrast for verification, unless there is gross evidence of infection. A CT scan with contrast will be obtained in those patients who are unable to undergo MRI for various reasons.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
- Background: PubMed 12603990Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
- Background: PubMed 16842714Bibbo C, Patel DV. The effect of demineralized bone matrix-calcium sulfate with vancomycin on calcaneal fracture healing and infection rates: a prospective study. Foot Ankle Int. 2006 Jul;27(7):487-93. doi: 10.1177/107110070602700702.
- Background: PubMed 19651846Branstetter JG, Jackson SR, Haggard WO, Richelsoph KC, Wenke JC. Locally-administered antibiotics in wounds in a limb. J Bone Joint Surg Br. 2009 Aug;91(8):1106-9. doi: 10.1302/0301-620X.91B8.22216.
- Background: PubMed 5487941Buchholz HW, Engelbrecht H. [Depot effects of various antibiotics mixed with Palacos resins]. Chirurg. 1970 Nov;41(11):511-5. No abstract available. German.
- Background: PubMed 8539047Calderone RR, Garland DE, Capen DA, Oster H. Cost of medical care for postoperative spinal infections. Orthop Clin North Am. 1996 Jan;27(1):171-82.
- Background: PubMed 7113232Burdon DW. Principles of antimicrobial prophylaxis. World J Surg. 1982 May;6(3):262-7. doi: 10.1007/BF01653540. No abstract available.
- Background: PubMed 19651948Cavanaugh DL, Berry J, Yarboro SR, Dahners LE. Better prophylaxis against surgical site infection with local as well as systemic antibiotics. An in vivo study. J Bone Joint Surg Am. 2009 Aug;91(8):1907-12. doi: 10.2106/JBJS.G.01237.
- Background: PubMed 3581579Dahners LE, Funderburk CH. Gentamicin-loaded plaster of Paris as a treatment of experimental osteomyelitis in rabbits. Clin Orthop Relat Res. 1987 Jun;(219):278-82.
- Background: PubMed 8981903Edin ML, Miclau T, Lester GE, Lindsey RW, Dahners LE. Effect of cefazolin and vancomycin on osteoblasts in vitro. Clin Orthop Relat Res. 1996 Dec;(333):245-51.
- Background: PubMed 12401922Gitelis S, Brebach GT. The treatment of chronic osteomyelitis with a biodegradable antibiotic-impregnated implant. J Orthop Surg (Hong Kong). 2002 Jun;10(1):53-60. doi: 10.1177/230949900201000110.
- Background: PubMed 8893444Glassman SD, Dimar JR, Puno RM, Johnson JR. Salvage of instrumental lumbar fusions complicated by surgical wound infection. Spine (Phila Pa 1976). 1996 Sep 15;21(18):2163-9. doi: 10.1097/00007632-199609150-00021.
- Background: PubMed 8875923Gold HS, Moellering RC Jr. Antimicrobial-drug resistance. N Engl J Med. 1996 Nov 7;335(19):1445-53. doi: 10.1056/NEJM199611073351907. No abstract available.
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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 Phase 4 study testing Vancomycin Powder in people with Wound Infection, run by University of Tennessee 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Nov 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Surgical Site Infection (time frame: 12 Months). 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 NCT01977989, which also lists 23 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 7 Nov 2013.