Post-Op ComplicationNCT06439953
Irrisept Solution for Instrumented Spine Surgery
A study testing Chlorhexidine gluconate solution and Vancomycin in people with Post-Op Complication and Spine Surgery, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Op Complication, Spine Surgery, Site Infection
- What is being tested?
- Chlorhexidine gluconate solution and Vancomycin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age: 18+ years old
- Indications: deformity, oncologic, degenerative, trauma
- Standard layer-by-layer closure
- Locoregional flap-based closure
Who cannot join
- Acute/chronic open wounds (spine or non-spine)
- On-going non-spinal infection within 30 days of index operation
- Concurrent antibiotic use (for spine or non-spine infections)
- History of prior spinal infection
- Allergy to vancomycin or chlorhexidine
- Suspicion for osteomyelitis
- Other surgery within 90 days post-operatively fromm index
- Concurrent enrollment in other trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Alexander Chernysh, 401-444-9868, AChernysh@Lifespan.org
Jared S. Fridley, MD
About this study
Official title: Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development.
Read the detailed description
Spinal instrumentation remains the standard of care in the treatment of various traumatic, oncologic, and degenerative spinal pathologies, often requiring the implantation of hardware to stabilize the bony column. In the setting of an aging patient population and expanding indications for instrumentation in younger patients, the number of spinal operations performed has risen substantially within the past decade. Although these procedures have proven to enhance patient quality of life, spinal instrumentation is not without post-operative complication, most notable of which are surgical site infection, seroma formation, and wound breakdown. Such complications can result in notable negative sequelae. Recurrent seroma may compress underlying neurologic structures or increase pressure along the incision, thereby precipitating wound dehiscence and inoculation of the surgical site with pathogenic organisms. Deep space infections often result in prolonged hospitalization, long-term suppressive antibiotic therapy, hardware removal, and permanent disability, which increases cost burden at the patient and hospital level. As such, preventative strategies to reduce the rate of complications following spinal instrumentation remain paramount. Within recent years, attention has turned to various irrigation methods to terminally sterilize prosthetic devices and wound beds, thereby minimizing bacterial colonization and biofilm formation that would otherwise predispose infection.
Irrisept (Irrimax Corporation, Gainesville, Florida) is a solution comprised of 0.05% chlorhexidine gluconate in 99.95% sterile water administered through a proprietary, low-pressure lavage mechanism that has demonstrated efficacy as a bacteriocidal agent in orthopedic hip and knee arthroplasty procedures. Whereas other antiseptic irrigation solutions, such as vancomycin-saline lavage, are routinely used to prevent surgical site infection, relative inertness against gram negative organisms and potential predisposition toward seroma formation render them non-ideal for use in spine surgery. Despite the utility of dilute chlorhexidine gluconate as a prophylactic irrigant, there exist gaps in knowledge with regard to the efficacy of Irrisept to prevent post-operative complications following spinal instrumentation. The central hypothesis of this proposal is that prophylactic use of Irrisept irrigation will result in fewer surgical site infections, clinically significant seromas, and gram negative or atypical infections when compared to standard of care irrigation (vancomycin-saline solution with or without topical vancomycin powder).
Proposed is a prospective, randomized controlled trial comparing rates of post-operative complications following use of Irrisept irrigation alone versus vancomycin-saline lavage with or without topical vancomycin powder (standard of care) in patients aged 18 years or older who undergo posterior cervical, thoracic, lumbar, and/or sacral spinal instrumentation for various indications (deformity, malignancy, degenerative pathology, and trauma) at Rhode Island Hospital.
- Conditions
- Post-Op Complication, Spine Surgery, Site Infection, Surgical Site Infection, Spinal Instrumentation, Index Spinal Instrumentation
- Being tested
- Chlorhexidine gluconate solution, Vancomycin
- Medical subject headings
- Postoperative Complications, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconate solutionDevice
Also called Irrisept irrigation
Evaluating the prophylactic use of Irrisept irrigation alone
VancomycinDrug
Also called Vancomycin-saline
Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin
| Study group | Role | What they receive |
|---|---|---|
| Irrisept Irrigation | Experimental | Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation. Receives: Device: Chlorhexidine gluconate solution |
| Vancomycin-saline Irrigation | Active comparator | Patients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of surgical site infection
Development of infection after index spinal instrumentation
Measured: 90 days post-operatively
Secondary outcomes (7)
Mortality
Capture mortality rates after index spinal instrumentation
Measured: 12 months post-operatively
Duration of index hospitalization
Capture duration of index hospitalization after index spinal instrumentation
Measured: 12 months post-operatively
Occurrence of 30-day readmission
Capture 30-day readmission rates after index spinal instrumentation
Measured: 30 days post-operatively
Occurrence of wound dehiscence
Capture all incidences of wound dehiscence after index spinal instrumentation
Measured: 12 months post-operatively
Time to closed suction drain removal
Capture the time interval to closed suction drain removal after index spinal instrumentation
Measured: 12 months post-operatively
Presence of atypical micro-organisms on wound fluid laboratory culture
Capture the presence of atypical micro-organisms after index spinal instrumentation
Measured: 12 months post-operatively
Cost of spine surgery care from surgery to 12-month post-operative follow up
Consider associated total costs of spinal instrumentation after index spinal instrumentation by comparing total surgical costs and post-surgical outcome expenses of those with and without Irrisept irrigation use
Measured: 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Oct 2024
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Post-Op ComplicationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jared S. Fridley, MD, Principal investigator, Rhode Island HospitalAlbert S. Woo, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439953
- Sponsor's protocol ID
- 2095643
- Status last verified
- Aug 2026
- First submitted
- 28 May 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338.
PubMed 20371784Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
PubMed 30074971Jain NK, Dao K, Ortiz AO. Radiologic evaluation and management of postoperative spine paraspinal fluid collections. Neuroimaging Clin N Am. 2014 May;24(2):375-89. doi: 10.1016/j.nic.2014.01.001.
PubMed 24792615Blumberg TJ, Woelber E, Bellabarba C, Bransford R, Spina N. Predictors of increased cost and length of stay in the treatment of postoperative spine surgical site infection. Spine J. 2018 Feb;18(2):300-306. doi: 10.1016/j.spinee.2017.07.173. Epub 2017 Jul 21.
PubMed 28739477de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
PubMed 19398246Torres KA, Konrade E, White J, Tavares Junior MCM, Bunch JT, Burton D, Jackson RS, Birlingmair J, Carlson BB. Irrigation techniques used in spine surgery for surgical site infection prophylaxis: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2022 Aug 26;23(1):813. doi: 10.1186/s12891-022-05763-2.
PubMed 36008858Yao R, Tan T, Tee JW, Street J. Prophylaxis of surgical site infection in adult spine surgery: A systematic review. J Clin Neurosci. 2018 Jun;52:5-25. doi: 10.1016/j.jocn.2018.03.023. Epub 2018 Mar 30.
PubMed 29609860Kapadia BH, Zhou PL, Jauregui JJ, Mont MA. Does Preadmission Cutaneous Chlorhexidine Preparation Reduce Surgical Site Infections After Total Knee Arthroplasty? Clin Orthop Relat Res. 2016 Jul;474(7):1592-8. doi: 10.1007/s11999-016-4767-6.
PubMed 26956247Johnson AJ, Kapadia BH, Daley JA, Molina CB, Mont MA. Chlorhexidine reduces infections in knee arthroplasty. J Knee Surg. 2013 Jun;26(3):213-8. doi: 10.1055/s-0032-1329232. Epub 2012 Nov 12.
PubMed 23288739Lung BE, Le R, Callan K, McLellan M, Issagholian L, Yi J, McMaster WC, Yang S, So DH. Chlorhexidine gluconate lavage during total joint arthroplasty may improve wound healing compared to dilute betadine. J Exp Orthop. 2022 Jul 10;9(1):67. doi: 10.1186/s40634-022-00503-w.
PubMed 35819733Ghobrial GM, Cadotte DW, Williams K Jr, Fehlings MG, Harrop JS. Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E11. doi: 10.3171/2015.7.FOCUS15258.
PubMed 26424335Youssef JA, Orndorff DG, Scott MA, Ebner RE, Knewitz AP. Sterile Seroma Resulting from Multilevel XLIF Procedure as Possible Adverse Effect of Prophylactic Vancomycin Powder: A Case Report. Evid Based Spine Care J. 2014 Oct;5(2):127-33. doi: 10.1055/s-0034-1386754.
PubMed 25364326Mallet C, Meissburger V, Caseris M, Happiette A, Chinnappa J, Bonacorsi S, Simon AL, Ilharreborde B. Does the use of intrawound povidone-iodine irrigation and local vancomycin powder impact surgical site infection rate in adolescent idiopathic scoliosis surgery? Eur Spine J. 2022 Nov;31(11):3020-3028. doi: 10.1007/s00586-022-07340-6. Epub 2022 Aug 1.
PubMed 35913622Schroeder JE, Girardi FP, Sandhu H, Weinstein J, Cammisa FP, Sama A. The use of local vancomycin powder in degenerative spine surgery. Eur Spine J. 2016 Apr;25(4):1029-33. doi: 10.1007/s00586-015-4119-3. Epub 2015 Aug 7.
PubMed 26249032Lemans JVC, Oner FC, Wijdicks SPJ, Ekkelenkamp MB, Vogely HC, Kruyt MC. The efficacy of intrawound vancomycin powder and povidone-iodine irrigation to prevent surgical site infections in complex instrumented spine surgery. Spine J. 2019 Oct;19(10):1648-1656. doi: 10.1016/j.spinee.2019.05.592. Epub 2019 May 31.
PubMed 31158503
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
- ClinicalTrials.gov ID
- NCT06439953
- Acronym / sponsor ID
- 2095643
- Conditions
- Post-Op Complication, Spine Surgery, Site Infection, Surgical Site Infection, Spinal Instrumentation, Index Spinal Instrumentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 3 Jun 2024 (actual)
- 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.
Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development.
Detailed description
Spinal instrumentation remains the standard of care in the treatment of various traumatic, oncologic, and degenerative spinal pathologies, often requiring the implantation of hardware to stabilize the bony column. In the setting of an aging patient population and expanding indications for instrumentation in younger patients, the number of spinal operations performed has risen substantially within the past decade. Although these procedures have proven to enhance patient quality of life, spinal instrumentation is not without post-operative complication, most notable of which are surgical site infection, seroma formation, and wound breakdown. Such complications can result in notable negative sequelae. Recurrent seroma may compress underlying neurologic structures or increase pressure along the incision, thereby precipitating wound dehiscence and inoculation of the surgical site with pathogenic organisms. Deep space infections often result in prolonged hospitalization, long-term suppressive antibiotic therapy, hardware removal, and permanent disability, which increases cost burden at the patient and hospital level. As such, preventative strategies to reduce the rate of complications following spinal instrumentation remain paramount. Within recent years, attention has turned to various irrigation methods to terminally sterilize prosthetic devices and wound beds, thereby minimizing bacterial colonization and biofilm formation that would otherwise predispose infection.
Irrisept (Irrimax Corporation, Gainesville, Florida) is a solution comprised of 0.05% chlorhexidine gluconate in 99.95% sterile water administered through a proprietary, low-pressure lavage mechanism that has demonstrated efficacy as a bacteriocidal agent in orthopedic hip and knee arthroplasty procedures. Whereas other antiseptic irrigation solutions, such as vancomycin-saline lavage, are routinely used to prevent surgical site infection, relative inertness against gram negative organisms and potential predisposition toward seroma formation render them non-ideal for use in spine surgery. Despite the utility of dilute chlorhexidine gluconate as a prophylactic irrigant, there exist gaps in knowledge with regard to the efficacy of Irrisept to prevent post-operative complications following spinal instrumentation. The central hypothesis of this proposal is that prophylactic use of Irrisept irrigation will result in fewer surgical site infections, clinically significant seromas, and gram negative or atypical infections when compared to standard of care irrigation (vancomycin-saline solution with or without topical vancomycin powder).
Proposed is a prospective, randomized controlled trial comparing rates of post-operative complications following use of Irrisept irrigation alone versus vancomycin-saline lavage with or without topical vancomycin powder (standard of care) in patients aged 18 years or older who undergo posterior cervical, thoracic, lumbar, and/or sacral spinal instrumentation for various indications (deformity, malignancy, degenerative pathology, and trauma) at Rhode Island Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irrisept Irrigation | Experimental | Device: Chlorhexidine gluconate solutionPatients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation. |
| Vancomycin-saline Irrigation | Active comparator | Drug: VancomycinPatients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18+ years old
- Indications: deformity, oncologic, degenerative, trauma
- Standard layer-by-layer closure
- Locoregional flap-based closure
Key exclusion criteria (8 listed)
- Acute/chronic open wounds (spine or non-spine)
- On-going non-spinal infection within 30 days of index operation
- Concurrent antibiotic use (for spine or non-spine infections)
- History of prior spinal infection
- Allergy to vancomycin or chlorhexidine
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 |
|---|---|---|
| Chlorhexidine gluconate solutionAlso: Irrisept irrigationEvaluating the prophylactic use of Irrisept irrigation alone | Device | Irrisept Irrigation |
| VancomycinAlso: Vancomycin-salineEvaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin | Drug | Vancomycin-saline Irrigation |
Primary outcome
Occurrence of surgical site infection
Time frame: 90 days post-operatively
Development of infection after index spinal instrumentation
7 secondary outcomes
Mortality
Time frame: 12 months post-operatively
Duration of index hospitalization
Time frame: 12 months post-operatively
Occurrence of 30-day readmission
Time frame: 30 days post-operatively
Occurrence of wound dehiscence
Time frame: 12 months post-operatively
Time to closed suction drain removal
Time frame: 12 months post-operatively
Presence of atypical micro-organisms on wound fluid laboratory culture
Time frame: 12 months post-operatively
Cost of spine surgery care from surgery to 12-month post-operative follow up
Time frame: 12 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 20371784Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338.
- Background: PubMed 30074971Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
- Background: PubMed 24792615Jain NK, Dao K, Ortiz AO. Radiologic evaluation and management of postoperative spine paraspinal fluid collections. Neuroimaging Clin N Am. 2014 May;24(2):375-89. doi: 10.1016/j.nic.2014.01.001.
- Background: PubMed 28739477Blumberg TJ, Woelber E, Bellabarba C, Bransford R, Spina N. Predictors of increased cost and length of stay in the treatment of postoperative spine surgical site infection. Spine J. 2018 Feb;18(2):300-306. doi: 10.1016/j.spinee.2017.07.173. Epub 2017 Jul 21.
- Background: PubMed 19398246de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
- Background: PubMed 36008858Torres KA, Konrade E, White J, Tavares Junior MCM, Bunch JT, Burton D, Jackson RS, Birlingmair J, Carlson BB. Irrigation techniques used in spine surgery for surgical site infection prophylaxis: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2022 Aug 26;23(1):813. doi: 10.1186/s12891-022-05763-2.
- Background: PubMed 29609860Yao R, Tan T, Tee JW, Street J. Prophylaxis of surgical site infection in adult spine surgery: A systematic review. J Clin Neurosci. 2018 Jun;52:5-25. doi: 10.1016/j.jocn.2018.03.023. Epub 2018 Mar 30.
- Background: PubMed 26956247Kapadia BH, Zhou PL, Jauregui JJ, Mont MA. Does Preadmission Cutaneous Chlorhexidine Preparation Reduce Surgical Site Infections After Total Knee Arthroplasty? Clin Orthop Relat Res. 2016 Jul;474(7):1592-8. doi: 10.1007/s11999-016-4767-6.
- Background: PubMed 23288739Johnson AJ, Kapadia BH, Daley JA, Molina CB, Mont MA. Chlorhexidine reduces infections in knee arthroplasty. J Knee Surg. 2013 Jun;26(3):213-8. doi: 10.1055/s-0032-1329232. Epub 2012 Nov 12.
- Background: PubMed 35819733Lung BE, Le R, Callan K, McLellan M, Issagholian L, Yi J, McMaster WC, Yang S, So DH. Chlorhexidine gluconate lavage during total joint arthroplasty may improve wound healing compared to dilute betadine. J Exp Orthop. 2022 Jul 10;9(1):67. doi: 10.1186/s40634-022-00503-w.
- Background: PubMed 26424335Ghobrial GM, Cadotte DW, Williams K Jr, Fehlings MG, Harrop JS. Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E11. doi: 10.3171/2015.7.FOCUS15258.
- Background: PubMed 25364326Youssef JA, Orndorff DG, Scott MA, Ebner RE, Knewitz AP. Sterile Seroma Resulting from Multilevel XLIF Procedure as Possible Adverse Effect of Prophylactic Vancomycin Powder: A Case Report. Evid Based Spine Care J. 2014 Oct;5(2):127-33. doi: 10.1055/s-0034-1386754.
- Individual participant dataSharing planned: Undecided
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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.
Jared S. Fridley, MD principal investigator
Rhode Island Hospital
Albert S. Woo, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine gluconate solution and Vancomycin in people with Post-Op Complication and Spine Surgery, run by Rhode Island Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Chernysh (401-444-9868, AChernysh@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of surgical site infection (time frame: 90 days post-operatively). 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 NCT06439953, which also lists 18 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 14 Aug 2026.