Surgical Site InfectionPhase 1NCT01764750
Dose Escalation Trial of Intrasite Vancomycin Pharmacokinetics
A Phase 1 study testing Intrasite Vancomycin and IV Vancomycin in people with Surgical Site Infection, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Surgical wound infections remain a serious problem despite aseptic techniques and the use of prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in high-risk patients receiving long segment instrumented spinal fusions for deformity correction and present potentially catastrophic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Intrasite Vancomycin and IV Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2013
- Phase
- Phase 1
- 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
- Posterior instrumented spinal surgery patients 18 years of age and older with instrumented fusion of at least three vertebral levels
- 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.
- Patients requiring IV Vancomycin for infection prophylaxis (i.e. due to cephalosporin allergy) will be eligible for participation in the IV Vancomycin group.
Who cannot join
- Intrasite Vancomycin Study Arm Exclusion Criteria
- Children under 18 years old
- 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.
- Patients not receiving wound drains
- drains provide the conduit for seroma fluid collection
Show all 26Show fewer
- Patients with known or suspected current infection
- Use of systemic or topical antibiotics within 72 hours prior to surgery
- other than standard pre-op dose of ancef
- Use of drugs or medications known to significantly increase the risk of renal toxicity within the perioperative period.
- Patients with known significant allergy to Vancomycin
- Redman Syndrome patients will not be excluded
- 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
- <!-- -->
- Children under 18 years old
- 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.
- Patients not receiving wound drains
- drains provide the conduit for seroma fluid collection
- Patients with known or suspected current infection
- Use of systemic or topical antibiotics within 72 hours prior to surgery
- other than study related IV Vancomycin
- Use of drugs or medications known to significantly increase the risk of renal toxicity within the perioperative period.
- Patients with known significant allergy to Vancomycin
- Redman Syndrome patients will not be excluded
- Use of intrasite Vancomycin for infection prophylaxis will exclude patients from participation in the IV Vancomycin study group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Dose-Escalation Trial of the Pharmacokinetics and Preliminary Safety of Intrasite Lyophilized Vancomycin to Prevent Wound Infections in Instrumented Spinal Surgery
Surgical wound infections remain a serious problem despite aseptic techniques and the use of prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in high-risk patients receiving long segment instrumented spinal fusions for deformity correction and present potentially catastrophic consequences. Given this, the high cost of treatment, and a payer system unable to support such expenses, investigators must make every effort to find new cost-effective ways to prevent these complications.
Increasingly surgeons have sought to address this problem by placing lyophilized Vancomycin into spinal surgery wounds immediately prior to wound closure. This method, known as "intrasite" application, is adapted from techniques used to prevent infection in joint replacement surgeries. The motivation for this practice is to maximize antibiotic concentration within the wound while minimizing systemic concentration and toxicity, (the inverse of the situation when using IV antibiotics). While the popularity of intrasite delivery has grown rapidly, this has occurred without prospective scientific evidence. Recently, three retrospective papers including nearly 2,500 treated patients, indicated that intrasite Vancomycin reduces wound infections without increasing adverse events[1-3]. However, there are no published data on the dosing or pharmacokinetics of intrasite Vancomycin, let alone prospective trials of its efficacy and safety.
The investigators propose to perform the first prospective trial of intrasite Vancomycin pharmacokinetics and safety. Study objectives will include standardizing application and dosing, defining peak/trough concentrations and clearance parameters, verifying bactericidal potency, and dose selection for use in future studies. This will be accomplished by enrolling groups of patients (n=10) to receive one of three doses of intrasite lyophilized Vancomycin (3, 6 or 12 mg/cm2), prior to wound closure. Vancomycin concentrations in venous blood and wound seroma fluid will be measured at regular intervals after surgery to establish pharmacokinetic parameters. Preliminary data regarding local and systemic adverse events including wound healing, fusion rate, and toxicity will be prospectively collected. The ultimate goal of this learning-phase study is to gather sufficient information regarding application, dosing, pharmacokinetics, measurement strategies, and adverse events to prepare for a Phase III efficacy trial.
Read the detailed description
Despite extremely close attention to aseptic technique and the use of prophylactic IV antibiotics, wound infection rates for posterior instrumented spinal surgery have been as high as ~20% in published studies[4-13]. Such infections can be devastating for patients, frequently requiring multiple re-operations to remove and then replace spinal implants, lengthy hospital stays, prolonged courses of intravenous antibiotics, pain, immobility, and increased risk of other complications. While the cost of the initial surgical episode can be upwards of $250,000, the total cost of care can increase to more than quadruple this number when complications like wound infection occur[14, 15]. Given the impetus to decrease healthcare costs and a federal reimbursement policy denying payment for any care surrounding a wound infection, it is critical to search for cost-effective ways of preventing surgical wound infections[14, 16].
For several decades the standard of care in North America for surgical wound infection prophylaxis has been IV cephalosporin administration within one hour of incision, followed by interval IV dosing for 24 to 48hrs post-procedure[5, 13]. In some settings these antibiotics now effectively treat less than half of identified infection-causing organisms[17, 18]. In response, some groups of surgeons, including at the investigators' own institution, have begun placing lyophilized Vancomycin into the surgical wound bed at the conclusion of the procedure in an effort to further reduce wound infection rates[1-3]. The rationale behind this intrasite antibiotic application is to increase local concentrations of antibiotic to many times the minimally inhibitory concentration (MIC) for even moderately-resistant gram-positive organisms, thereby increasing the bacterial kill rate[3]. It is also thought that local antibiotic application should minimize blood concentrations of the drug, thereby minimizing systemic complications like renal toxicity. Additionally, it is hypothesized that intrasite antibiotic therapy could be less inclined to generate resistant organisms due to a steep concentration gradient from the wound to the systemic circulation. The site of potential infection (the wound) receives a dose of antibiotic vastly exceeding the saturation concentration for bactericidal effect while the systemic concentration remains extremely low. Bacteria should therefore be completely exterminated in the area of the wound or elsewhere exposed to such a minimal concentration of Vancomycin that selection for resistant organisms is avoided.
While none of these hypotheses have been rigorously or prospectively tested, three retrospective studies have recently published a total of 2,479 spinal fusion patients treated with intrasite Vancomycin for wound infection prophylaxis[1-3]. The largest of these studies demonstrated a 0.99% infection rate in the treatment group, among the lowest rates ever published[1]. Two of the studies showed large and statistically significant decreases in the wound infection rate, compared to historical controls, when using intrasite Vancomycin in addition to standard of care IV cephalosporins. Preliminary evidence in one study also indicated high levels of Vancomycin within the wound and low or undetectable levels within the blood following surgery[3]. All of these studies specifically cited that no adverse events had been observed related to the treatment[1-3].
If intrasite Vancomycin proves to be safe and effective for preventing spinal fusion surgical site infections, the treatment will offer great clinical value both for reducing morbidity and also for decreasing large unsupported costs. A future large prospective efficacy trial would be required to provide high-level evidence for this new mode of antibiotic therapy in order to justify wide-spread adoption of the practice in spine surgery. Such data in any population might also be generalizable to surgical wounds at large and prompt a paradigm shift in infection prophylaxis for all types of surgical wounds. The proposed study addresses necessary prerequisites for such a large-scale efficacy trial, including basic pharmacokinetic and preliminary prospective safety data.
- Conditions
- Surgical Site Infection
- Being tested
- Intrasite Vancomycin, IV Vancomycin
- Keywords
- Intrasite, Antibiotic, Vancomycin, Infection, Pharmacokinetics
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrasite VancomycinDrug
Intrasite Vancomycin is placement of lyophilized Vancomycin powder directly into the surgical site at the completion of surgery.
IV VancomycinDrug
IV Vancomycin is the standard route for systemic antibiotic surgical site wound infection prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Intrasite Vancomycin | Experimental | 10 patients will be enrolled to receive low dose (see protocol) intrasite Vancomycin at the time of surgery. This will be the first group enrolled in the dose-escalation trial. Receives: Drug: Intrasite Vancomycin |
| Mid-dose Intrasite Vancomycin | Experimental | 10 patients will be enrolled to receive mid-dose intrasite Vancomycin at the time of surgery. Receives: Drug: Intrasite Vancomycin |
| High-dose Intrasite Vancomycin | Experimental | 10 patients will be enrolled to receive high-dose intrasite Vancomycin at the time of surgery. Receives: Drug: Intrasite Vancomycin |
| Optimally-dosed IV Vancomycin | Active comparator | 10 patients will be enrolled to receive optimally-dosed IV Vancomycin at the time of surgery and two doses post-operatively (standard peri-operative IV antibiotics) Receives: Drug: IV Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Vancomycin Concentration
Blood Vancomycin concentration will be measured within two hours post-operatively as well as each morning (between 07:00 and 09:00) until the surgical drain is removed (normally around 4 days after surgery).
Measured: Post-operatively at daily intervals until surgical drain is removed (average of 4 days after surgery)
Seroma Vancomycin Concentration
Seroma Vancomycin concentration will be measured within two hours post-operatively as well as each morning (between 07:00 and 09:00) until the surgical drain is removed (normally around 4 days after surgery).
Measured: Post-operatively at daily intervals until surgical drain is removed (average of 4 days after surgery)
Secondary outcomes (1)
Blood creatinine concentration
Blood serum creatinine concentration will be measured at daily intervals each morning (between 07:00 to 09:00) post-operatively until surgical drain is removed approximately 4 days after surgery.
Measured: Post-operatively at daily intervals until surgical drain is removed (average of 4 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: awaiting FDA approval for next dose group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terrence F Holekamp, MD, PhD, Principal investigator, Washington University School of MedicineLawrence G Lenke, MD, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764750
- Sponsor's protocol ID
- 2012IntrasiteVanc
- Status last verified
- May 2018
- First submitted
- 14 Dec 2012
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Molinari RW, Khera OA, Molinari WJ 3rd. Prophylactic intraoperative powdered vancomycin and postoperative deep spinal wound infection: 1,512 consecutive surgical cases over a 6-year period. Eur Spine J. 2012 Jun;21 Suppl 4(Suppl 4):S476-82. doi: 10.1007/s00586-011-2104-z. Epub 2011 Dec 8.
PubMed 22160172O'Neill KR, Smith JG, Abtahi AM, Archer KR, Spengler DM, McGirt MJ, Devin CJ. Reduced surgical site infections in patients undergoing posterior spinal stabilization of traumatic injuries using vancomycin powder. Spine J. 2011 Jul;11(7):641-6. doi: 10.1016/j.spinee.2011.04.025. Epub 2011 May 19.
PubMed 21600853Sweet FA, Roh M, Sliva C. Intrawound application of vancomycin for prophylaxis in instrumented thoracolumbar fusions: efficacy, drug levels, and patient outcomes. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2084-8. doi: 10.1097/BRS.0b013e3181ff2cb1.
PubMed 21304438Friedman ND, Sexton DJ, Connelly SM, Kaye KS. Risk factors for surgical site infection complicating laminectomy. Infect Control Hosp Epidemiol. 2007 Sep;28(9):1060-5. doi: 10.1086/519864. Epub 2007 Jun 28.
PubMed 17932827Olsen MA, Nepple JJ, Riew KD, Lenke LG, Bridwell KH, Mayfield J, Fraser VJ. Risk factors for surgical site infection following orthopaedic spinal operations. J Bone Joint Surg Am. 2008 Jan;90(1):62-9. doi: 10.2106/JBJS.F.01515.
PubMed 18171958Linam WM, Margolis PA, Staat MA, Britto MT, Hornung R, Cassedy A, Connelly BL. Risk factors associated with surgical site infection after pediatric posterior spinal fusion procedure. Infect Control Hosp Epidemiol. 2009 Feb;30(2):109-16. doi: 10.1086/593952.
PubMed 19125680Pull ter Gunne AF, Cohen DB. Incidence, prevalence, and analysis of risk factors for surgical site infection following adult spinal surgery. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1422-8. doi: 10.1097/BRS.0b013e3181a03013.
PubMed 19478664Pull ter Gunne AF, Mohamed AS, Skolasky RL, van Laarhoven CJ, Cohen DB. The presentation, incidence, etiology, and treatment of surgical site infections after spinal surgery. Spine (Phila Pa 1976). 2010 Jun 1;35(13):1323-8. doi: 10.1097/BRS.0b013e3181bcde61.
PubMed 20150831Schimmel JJ, Horsting PP, de Kleuver M, Wonders G, van Limbeek J. Risk factors for deep surgical site infections after spinal fusion. Eur Spine J. 2010 Oct;19(10):1711-9. doi: 10.1007/s00586-010-1421-y. Epub 2010 May 6.
PubMed 20445999Gerometta A, Rodriguez Olaverri JC, Bitan F. Infections in spinal instrumentation. Int Orthop. 2012 Feb;36(2):457-64. doi: 10.1007/s00264-011-1426-0. Epub 2012 Jan 5.
PubMed 22218913Li Y, Glotzbecker M, Hedequist D. Surgical site infection after pediatric spinal deformity surgery. Curr Rev Musculoskelet Med. 2012;5(2):111-9. doi: 10.1007/s12178-012-9111-5. Epub 2012 Feb 9.
PubMed 22315161Pull ter Gunne AF, Hosman AJ, Cohen DB, Schuetz M, Habil D, van Laarhoven CJ, van Middendorp JJ. A methodological systematic review on surgical site infections following spinal surgery: part 1: risk factors. Spine (Phila Pa 1976). 2012 Nov 15;37(24):2017-33. doi: 10.1097/BRS.0b013e31825bfca8.
PubMed 22565388van Middendorp JJ, Pull ter Gunne AF, Schuetz M, Habil D, Cohen DB, Hosman AJ, van Laarhoven CJ. A methodological systematic review on surgical site infections following spinal surgery: part 2: prophylactic treatments. Spine (Phila Pa 1976). 2012 Nov 15;37(24):2034-45. doi: 10.1097/BRS.0b013e31825f6652.
PubMed 22648023Graf K, Ott E, Vonberg RP, Kuehn C, Schilling T, Haverich A, Chaberny IF. Surgical site infections--economic consequences for the health care system. Langenbecks Arch Surg. 2011 Apr;396(4):453-9. doi: 10.1007/s00423-011-0772-0. Epub 2011 Mar 15.
PubMed 21404004Calderone 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 8539047
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Dose-Escalation Trial of the Pharmacokinetics and Preliminary Safety of Intrasite Lyophilized Vancomycin to Prevent Wound Infections in Instrumented Spinal Surgery
- ClinicalTrials.gov ID
- NCT01764750
- Acronym / sponsor ID
- 2012IntrasiteVanc
- Conditions
- Surgical Site Infection
- Keywords
- Intrasite, Antibiotic, Vancomycin, Infection, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: awaiting FDA approval for next dose group
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Jan 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.
Surgical wound infections remain a serious problem despite aseptic techniques and the use of prophylactic systemic antibiotics. Such infections can occur at rates up to ~20% in high-risk patients receiving long segment instrumented spinal fusions for deformity correction and present potentially catastrophic consequences. Given this, the high cost of treatment, and a payer system unable to support such expenses, investigators must make every effort to find new cost-effective ways to prevent these complications.
Increasingly surgeons have sought to address this problem by placing lyophilized Vancomycin into spinal surgery wounds immediately prior to wound closure. This method, known as "intrasite" application, is adapted from techniques used to prevent infection in joint replacement surgeries. The motivation for this practice is to maximize antibiotic concentration within the wound while minimizing systemic concentration and toxicity, (the inverse of the situation when using IV antibiotics). While the popularity of intrasite delivery has grown rapidly, this has occurred without prospective scientific evidence. Recently, three retrospective papers including nearly 2,500 treated patients, indicated that intrasite Vancomycin reduces wound infections without increasing adverse events[1-3]. However, there are no published data on the dosing or pharmacokinetics of intrasite Vancomycin, let alone prospective trials of its efficacy and safety.
The investigators propose to perform the first prospective trial of intrasite Vancomycin pharmacokinetics and safety. Study objectives will include standardizing application and dosing, defining peak/trough concentrations and clearance parameters, verifying bactericidal potency, and dose selection for use in future studies. This will be accomplished by enrolling groups of patients (n=10) to receive one of three doses of intrasite lyophilized Vancomycin (3, 6 or 12 mg/cm2), prior to wound closure. Vancomycin concentrations in venous blood and wound seroma fluid will be measured at regular intervals after surgery to establish pharmacokinetic parameters. Preliminary data regarding local and systemic adverse events including wound healing, fusion rate, and toxicity will be prospectively collected. The ultimate goal of this learning-phase study is to gather sufficient information regarding application, dosing, pharmacokinetics, measurement strategies, and adverse events to prepare for a Phase III efficacy trial.
Detailed description
Despite extremely close attention to aseptic technique and the use of prophylactic IV antibiotics, wound infection rates for posterior instrumented spinal surgery have been as high as ~20% in published studies[4-13]. Such infections can be devastating for patients, frequently requiring multiple re-operations to remove and then replace spinal implants, lengthy hospital stays, prolonged courses of intravenous antibiotics, pain, immobility, and increased risk of other complications. While the cost of the initial surgical episode can be upwards of $250,000, the total cost of care can increase to more than quadruple this number when complications like wound infection occur[14, 15]. Given the impetus to decrease healthcare costs and a federal reimbursement policy denying payment for any care surrounding a wound infection, it is critical to search for cost-effective ways of preventing surgical wound infections[14, 16].
For several decades the standard of care in North America for surgical wound infection prophylaxis has been IV cephalosporin administration within one hour of incision, followed by interval IV dosing for 24 to 48hrs post-procedure[5, 13]. In some settings these antibiotics now effectively treat less than half of identified infection-causing organisms[17, 18]. In response, some groups of surgeons, including at the investigators' own institution, have begun placing lyophilized Vancomycin into the surgical wound bed at the conclusion of the procedure in an effort to further reduce wound infection rates[1-3]. The rationale behind this intrasite antibiotic application is to increase local concentrations of antibiotic to many times the minimally inhibitory concentration (MIC) for even moderately-resistant gram-positive organisms, thereby increasing the bacterial kill rate[3]. It is also thought that local antibiotic application should minimize blood concentrations of the drug, thereby minimizing systemic complications like renal toxicity. Additionally, it is hypothesized that intrasite antibiotic therapy could be less inclined to generate resistant organisms due to a steep concentration gradient from the wound to the systemic circulation. The site of potential infection (the wound) receives a dose of antibiotic vastly exceeding the saturation concentration for bactericidal effect while the systemic concentration remains extremely low. Bacteria should therefore be completely exterminated in the area of the wound or elsewhere exposed to such a minimal concentration of Vancomycin that selection for resistant organisms is avoided.
While none of these hypotheses have been rigorously or prospectively tested, three retrospective studies have recently published a total of 2,479 spinal fusion patients treated with intrasite Vancomycin for wound infection prophylaxis[1-3]. The largest of these studies demonstrated a 0.99% infection rate in the treatment group, among the lowest rates ever published[1]. Two of the studies showed large and statistically significant decreases in the wound infection rate, compared to historical controls, when using intrasite Vancomycin in addition to standard of care IV cephalosporins. Preliminary evidence in one study also indicated high levels of Vancomycin within the wound and low or undetectable levels within the blood following surgery[3]. All of these studies specifically cited that no adverse events had been observed related to the treatment[1-3].
If intrasite Vancomycin proves to be safe and effective for preventing spinal fusion surgical site infections, the treatment will offer great clinical value both for reducing morbidity and also for decreasing large unsupported costs. A future large prospective efficacy trial would be required to provide high-level evidence for this new mode of antibiotic therapy in order to justify wide-spread adoption of the practice in spine surgery. Such data in any population might also be generalizable to surgical wounds at large and prompt a paradigm shift in infection prophylaxis for all types of surgical wounds. The proposed study addresses necessary prerequisites for such a large-scale efficacy trial, including basic pharmacokinetic and preliminary prospective safety data.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose Intrasite Vancomycin | Experimental | Drug: Intrasite Vancomycin10 patients will be enrolled to receive low dose (see protocol) intrasite Vancomycin at the time of surgery. This will be the first group enrolled in the dose-escalation trial. |
| Mid-dose Intrasite Vancomycin | Experimental | Drug: Intrasite Vancomycin10 patients will be enrolled to receive mid-dose intrasite Vancomycin at the time of surgery. |
| High-dose Intrasite Vancomycin | Experimental | Drug: Intrasite Vancomycin10 patients will be enrolled to receive high-dose intrasite Vancomycin at the time of surgery. |
| Optimally-dosed IV Vancomycin | Active comparator | Drug: IV Vancomycin10 patients will be enrolled to receive optimally-dosed IV Vancomycin at the time of surgery and two doses post-operatively (standard peri-operative IV antibiotics) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Posterior instrumented spinal surgery patients 18 years of age and older with instrumented fusion of at least three vertebral levels
- Patients requiring IV Vancomycin for infection prophylaxis (i.e. due to cephalosporin allergy) will be eligible for participation in the IV Vancomycin group.
Key exclusion criteria (26 listed)
- Intrasite Vancomycin Study Arm Exclusion Criteria
- Children under 18 years old
- Patients not receiving instrumentation or having less than three segment surgery
- Patients not receiving wound drains
- Patients with known or suspected current infection
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 |
|---|---|---|
| Intrasite VancomycinIntrasite Vancomycin is placement of lyophilized Vancomycin powder directly into the surgical site at the completion of surgery. | Drug | High-dose Intrasite Vancomycin, Low Dose Intrasite Vancomycin, Mid-dose Intrasite Vancomycin |
| IV VancomycinIV Vancomycin is the standard route for systemic antibiotic surgical site wound infection prophylaxis. | Drug | Optimally-dosed IV Vancomycin |
Primary outcome
Blood Vancomycin Concentration
Time frame: Post-operatively at daily intervals until surgical drain is removed (average of 4 days after surgery)
Blood Vancomycin concentration will be measured within two hours post-operatively as well as each morning (between 07:00 and 09:00) until the surgical drain is removed (normally around 4 days after surgery).
Seroma Vancomycin Concentration
Time frame: Post-operatively at daily intervals until surgical drain is removed (average of 4 days after surgery)
Seroma Vancomycin concentration will be measured within two hours post-operatively as well as each morning (between 07:00 and 09:00) until the surgical drain is removed (normally around 4 days after surgery).
1 secondary outcome
Blood creatinine concentration
Time frame: Post-operatively at daily intervals until surgical drain is removed (average of 4 days after surgery)
Results and safety
The study was stopped early (reason given: awaiting FDA approval for next dose group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 22160172Molinari RW, Khera OA, Molinari WJ 3rd. Prophylactic intraoperative powdered vancomycin and postoperative deep spinal wound infection: 1,512 consecutive surgical cases over a 6-year period. Eur Spine J. 2012 Jun;21 Suppl 4(Suppl 4):S476-82. doi: 10.1007/s00586-011-2104-z. Epub 2011 Dec 8.
- Background: PubMed 21600853O'Neill KR, Smith JG, Abtahi AM, Archer KR, Spengler DM, McGirt MJ, Devin CJ. Reduced surgical site infections in patients undergoing posterior spinal stabilization of traumatic injuries using vancomycin powder. Spine J. 2011 Jul;11(7):641-6. doi: 10.1016/j.spinee.2011.04.025. Epub 2011 May 19.
- Background: PubMed 21304438Sweet FA, Roh M, Sliva C. Intrawound application of vancomycin for prophylaxis in instrumented thoracolumbar fusions: efficacy, drug levels, and patient outcomes. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2084-8. doi: 10.1097/BRS.0b013e3181ff2cb1.
- Background: PubMed 17932827Friedman ND, Sexton DJ, Connelly SM, Kaye KS. Risk factors for surgical site infection complicating laminectomy. Infect Control Hosp Epidemiol. 2007 Sep;28(9):1060-5. doi: 10.1086/519864. Epub 2007 Jun 28.
- Background: PubMed 18171958Olsen MA, Nepple JJ, Riew KD, Lenke LG, Bridwell KH, Mayfield J, Fraser VJ. Risk factors for surgical site infection following orthopaedic spinal operations. J Bone Joint Surg Am. 2008 Jan;90(1):62-9. doi: 10.2106/JBJS.F.01515.
- Background: PubMed 19125680Linam WM, Margolis PA, Staat MA, Britto MT, Hornung R, Cassedy A, Connelly BL. Risk factors associated with surgical site infection after pediatric posterior spinal fusion procedure. Infect Control Hosp Epidemiol. 2009 Feb;30(2):109-16. doi: 10.1086/593952.
- Background: PubMed 19478664Pull ter Gunne AF, Cohen DB. Incidence, prevalence, and analysis of risk factors for surgical site infection following adult spinal surgery. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1422-8. doi: 10.1097/BRS.0b013e3181a03013.
- Background: PubMed 20150831Pull ter Gunne AF, Mohamed AS, Skolasky RL, van Laarhoven CJ, Cohen DB. The presentation, incidence, etiology, and treatment of surgical site infections after spinal surgery. Spine (Phila Pa 1976). 2010 Jun 1;35(13):1323-8. doi: 10.1097/BRS.0b013e3181bcde61.
- Background: PubMed 20445999Schimmel JJ, Horsting PP, de Kleuver M, Wonders G, van Limbeek J. Risk factors for deep surgical site infections after spinal fusion. Eur Spine J. 2010 Oct;19(10):1711-9. doi: 10.1007/s00586-010-1421-y. Epub 2010 May 6.
- Background: PubMed 22218913Gerometta A, Rodriguez Olaverri JC, Bitan F. Infections in spinal instrumentation. Int Orthop. 2012 Feb;36(2):457-64. doi: 10.1007/s00264-011-1426-0. Epub 2012 Jan 5.
- Background: PubMed 22315161Li Y, Glotzbecker M, Hedequist D. Surgical site infection after pediatric spinal deformity surgery. Curr Rev Musculoskelet Med. 2012;5(2):111-9. doi: 10.1007/s12178-012-9111-5. Epub 2012 Feb 9.
- Background: PubMed 22565388Pull ter Gunne AF, Hosman AJ, Cohen DB, Schuetz M, Habil D, van Laarhoven CJ, van Middendorp JJ. A methodological systematic review on surgical site infections following spinal surgery: part 1: risk factors. Spine (Phila Pa 1976). 2012 Nov 15;37(24):2017-33. doi: 10.1097/BRS.0b013e31825bfca8.
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Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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.
Terrence F Holekamp, MD, PhD principal investigator
Washington University School of Medicine
Lawrence G Lenke, MD study chair
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intrasite Vancomycin and IV Vancomycin in people with Surgical Site Infection, run by Washington University School of Medicine 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 26 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: stopped early, as of the sponsor's last update on 11 May 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: awaiting FDA approval for next dose group). 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?
Blood Vancomycin Concentration (time frame: Post-operatively at daily intervals until surgical drain is removed (average of 4 days after surgery)). The study lists 2 primary outcomes in all. 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 NCT01764750, which also lists 22 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 11 May 2018.