Arthroplasty ComplicationsPhase 2NCT05697965
LocalVancomycinPowderToPreventPeriprostheticJointInfection.
A Phase 2 study testing Vancomycin and Total knee or total hip arthroplasty in people with Arthroplasty Complications and Periprosthetic Fracture of Hip, run by Assiut University.
Trial summary
The purpose of this study is to evaluate the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty Complications, Periprosthetic Fracture of Hip
- What is being tested?
- Vancomycin and Total knee or total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to Aug 2024
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients population who will undergo primary total knee or total hip arthroplasty
Who cannot join
- patients with diabetes mellitus inflammatory arthritis diseases smokers BMI > 40
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TheUseofLocalVancomycinPowdertoPreventPeriprostheticJointInfectioninPrimaryTotalHipandKneeArthroplasty.ARandomizedControlledTrial.
The purpose of this study is to evaluate the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly.
Read the detailed description
Periprosthetic joint infection is a truly devastating complication of total joint arthroplasty (TJA), causing most patients to undergo a revision surgery and to bear significant psychological and financial burden. Surveys suggest patients of total joint arthroplasty undergoing revision for infection have poorer functional outcomes and satisfaction levels than patients undergoing revision for other reasons, with negative consequences being more persistent .
Despite developments in infection prophylaxis and risk factor mitigation, patients with periprosthetic joint infection represent a substantial societal and monetary cost to our value-based health care system. Thus, there is significant interest in developing and systematically evaluating new PJI prophylaxis measures to reduce this rate.
Historically, local wound vancomycin powder has been shown to safely reduce infection rates in spine surgery. The earliest and strongest support for local vancomycin powder for primary orthopedic surgery came from the spine literature, and it now has support in the shoulder and elbow and foot and ankle literature. The use of topical vancomycin was first reported in 1989 when the application of topical vancomycin to the sternum in cardio thoracic patients reduced rates of sternal infection from 3.6% to 0.45%). Similarly, multiple studies have shown that vancomycin decreases the rate of postoperative infections in patients undergoing spinal surgery.
Importantly, data on topical vancomycin powder used alone remain inconclusive for TJA, with some stating that it may increase aseptic wound complications, and others stating that it reduces PJI significantly .
- Being tested
- Vancomycin, Total knee or total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Also called Vancomycin sulphate
applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty to prevent periprosthetic joint infection
Total knee or total hip arthroplastyProcedure or surgery
Primary total knee or total hip arthroplasty without using local vancomycin
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin loaded group | Experimental | applying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty operations Receives: Drug: Vancomycin; Procedure: Total knee or total hip arthroplasty |
| Non vancomycin loaded group | Experimental | Total knee \& hip arthroplasty done without applying local vancomycin powder comparing the results with vancomycin loaded group Receives: Procedure: Total knee or total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow up for infected patients after 90 days with surgical site infection.
The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. The use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly that will be evaluated by inflammatory markers CRP (if more than 1 gm/dl), ESR(more than 20) as laboratory investigations.
Measured: 3 months after operation
Secondary outcomes (1)
Aseptic wound complications such as skin erosion, wound dehiscence, and prolonged wound healing.
The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly by examination wound site if there's surgical site infection, dehescience, abscess, discharge.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maro Maher Botros Boktor, Assiut University
- Investigators
- Yossef Saleh, Principal investigator, Vice president
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697965
- Sponsor's protocol ID
- Vancomycin in Arthroplasty
- Status last verified
- Feb 2023
- First submitted
- 12 Jul 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wukich DK, Dikis JW, Monaco SJ, Strannigan K, Suder NC, Rosario BL. Topically Applied Vancomycin Powder Reduces the Rate of Surgical Site Infection in Diabetic Patients Undergoing Foot and Ankle Surgery. Foot Ankle Int. 2015 Sep;36(9):1017-24. doi: 10.1177/1071100715586567. Epub 2015 May 12.
PubMed 25967254Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.
PubMed 22554729Sweet 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 21304438Yan H, He J, Chen S, Yu S, Fan C. Intrawound application of vancomycin reduces wound infection after open release of post-traumatic stiff elbows: a retrospective comparative study. J Shoulder Elbow Surg. 2014 May;23(5):686-92. doi: 10.1016/j.jse.2014.01.049.
PubMed 24745317
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TheUseofLocalVancomycinPowdertoPreventPeriprostheticJointInfectioninPrimaryTotalHipandKneeArthroplasty.ARandomizedControlledTrial.
- ClinicalTrials.gov ID
- NCT05697965
- Acronym / sponsor ID
- Vancomycin in Arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 Jan 2023 (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.
The purpose of this study is to evaluate the efficacy and complication profile of local vancomycin application in primary arthroplasty. The investigators hypothesized that the use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly.
Detailed description
Periprosthetic joint infection is a truly devastating complication of total joint arthroplasty (TJA), causing most patients to undergo a revision surgery and to bear significant psychological and financial burden. Surveys suggest patients of total joint arthroplasty undergoing revision for infection have poorer functional outcomes and satisfaction levels than patients undergoing revision for other reasons, with negative consequences being more persistent .
Despite developments in infection prophylaxis and risk factor mitigation, patients with periprosthetic joint infection represent a substantial societal and monetary cost to our value-based health care system. Thus, there is significant interest in developing and systematically evaluating new PJI prophylaxis measures to reduce this rate.
Historically, local wound vancomycin powder has been shown to safely reduce infection rates in spine surgery. The earliest and strongest support for local vancomycin powder for primary orthopedic surgery came from the spine literature, and it now has support in the shoulder and elbow and foot and ankle literature. The use of topical vancomycin was first reported in 1989 when the application of topical vancomycin to the sternum in cardio thoracic patients reduced rates of sternal infection from 3.6% to 0.45%). Similarly, multiple studies have shown that vancomycin decreases the rate of postoperative infections in patients undergoing spinal surgery.
Importantly, data on topical vancomycin powder used alone remain inconclusive for TJA, with some stating that it may increase aseptic wound complications, and others stating that it reduces PJI significantly .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin loaded group | Experimental | Drug: Vancomycin, Procedure: Total knee or total hip arthroplastyapplying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty operations |
| Non vancomycin loaded group | Experimental | Procedure: Total knee or total hip arthroplastyTotal knee \& hip arthroplasty done without applying local vancomycin powder comparing the results with vancomycin loaded group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients population who will undergo primary total knee or total hip arthroplasty
Key exclusion criteria (1 listed)
- patients with diabetes mellitus inflammatory arthritis diseases smokers BMI > 40
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 |
|---|---|---|
| VancomycinAlso: Vancomycin sulphateapplying 1 gm of vancomycin powder intracapsularly during primary total knee and hip arthroplasty to prevent periprosthetic joint infection | Drug | Vancomycin loaded group |
| Total knee or total hip arthroplastyPrimary total knee or total hip arthroplasty without using local vancomycin | Procedure or surgery | Non vancomycin loaded group, Vancomycin loaded group |
Primary outcome
Follow up for infected patients after 90 days with surgical site infection.
Time frame: 3 months after operation
The purpose of this study is evaluation of the efficacy and complication profile of local vancomycin application in primary arthroplasty. The use of local antibiotics would decrease the rate of infection compared to controls and this will be achieved by applying 1 gm of vancomycin powder intracapsularly that will be evaluated by inflammatory markers CRP (if more than 1 gm/dl), ESR(more than 20) as laboratory investigations.
1 secondary outcome
Aseptic wound complications such as skin erosion, wound dehiscence, and prolonged wound healing.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 25967254Wukich DK, Dikis JW, Monaco SJ, Strannigan K, Suder NC, Rosario BL. Topically Applied Vancomycin Powder Reduces the Rate of Surgical Site Infection in Diabetic Patients Undergoing Foot and Ankle Surgery. Foot Ankle Int. 2015 Sep;36(9):1017-24. doi: 10.1177/1071100715586567. Epub 2015 May 12.
- Background: PubMed 22554729Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.
- 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 24745317Yan H, He J, Chen S, Yu S, Fan C. Intrawound application of vancomycin reduces wound infection after open release of post-traumatic stiff elbows: a retrospective comparative study. J Shoulder Elbow Surg. 2014 May;23(5):686-92. doi: 10.1016/j.jse.2014.01.049.
Related trials for Arthroplasty Complications
Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
Active, not recruitingObservational study
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Rheumatoid Arthritis, Ankylosing Spondylitis
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.
Yossef Saleh principal investigator
Vice president
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin and Total knee or total hip arthroplasty in people with Arthroplasty Complications and Periprosthetic Fracture of Hip, run by Assiut University.
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 1 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Maro Boktor, Master (+01023454251, marombb54@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow up for infected patients after 90 days with surgical site infection. (time frame: 3 months after operation). 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 NCT05697965, which also lists 4 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 10 Feb 2023.