Surgical Site InfectionPhase 4NCT05535725
Application of Powdered Vancomycin in the Surgical Wound in Haiti
A Phase 4 study testing application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection in people with Surgical Site Infection, run by Clinique Ortos at 1 site in Haiti.
Trial summary
Vancomycin, a tricyclic glycopeptide antibiotic, was originally indicated for the treatment of penicillin-resistant S. Aureus. It has a bactericidal action, inhibiting the biosynthesis of the cell wall of Gram-positive bacteria. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteHaiti
- Study dates
- 10 Oct 2019to 5 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with 18 years and older
- lower extremity fractures
Who cannot join
- patients with impaired consciousness,
- those with an open Gustillo and Anderson type III fracture
- those with a C reactive protein > 6.
- those with date of trauma more than 48 hours
- those with passage of purulent secretion in the wound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Blinded Randomized Clinical Trial on the Application of Powdered Vancomycin in the Surgical Wound as Prophylaxis Against the Occurrence of Surgical Site Infection at La Paix State University Hospital Haiti
Vancomycin, a tricyclic glycopeptide antibiotic, was originally indicated for the treatment of penicillin-resistant S. Aureus. It has a bactericidal action, inhibiting the biosynthesis of the cell wall of Gram-positive bacteria. Various studies have reported the application of intraoperative vancomycin powder to the wound prior to wound closure as a method of antibiotic prophylaxis. Intrasite administration of the drug should theoretically minimize rapid absorption into the systemic circulation, thereby reducing drug-associated side effects. The precipitated concentration gradient between the local wound and the scaffold should also reduce the occurrence of drug resistance. In Haiti, monitoring patients post-operatively is often difficult. The Mortality, Morbidity and Use of Services Survey (EMMUS-VI 2016-2017) reports that the non-use of a health facility is motivated in 58% of cases by the excessively high economic cost of care. Also, SSIs represent a challenge for clinicians. The best solution to the consequences of SSI in this context is prevention. In the present study, the investigator tested the hypothesis that the use of vancomycin powder in the surgical wound would decrease the occurrence of SSI.
Read the detailed description
Type of study
This is a single-center prospective study with balanced blind randomization 1: 1 in parallel group.
Method and materials
After approval of the research protocol by the hospital ethics committee, the randomization sequence will be created using Stata 9.0 ware statistical software and will be stratified by center with a 1:1 allocation using random block sizes of 2, 4 and 6." "Participants will be randomly assigned following simple randomization procedures to 1 of 2 treatment groups. A group of patients will receive 2g of powdered vancomycin in the operative wound before its closure, and another group will not receive it. Both groups will benefit from the same preoperative asepsis protocol. One hour before the incision, 1g of intravenous ceftriaxone will be administered to the patients, this dose is maintained during the 48 hours postoperative every 12 hours. At discharged the two groups of patients will receive oral cloxacilin 500mg three times a day for one week. Patients are dressed every 2 days until the surgical wound has healed. Patients will be seen in the outpatient clinic at 2, 4, and 6 weeks, then at one year.
The significance level for the statistical tests is 0.05%. investigator used chi-square tests to assess the degree of relationship. The frequency of the patient's demographic, clinical and therapeutic characteristics are calculated. We used pubmed, google scholar, medline to perform the literature review. The consort guide will be used for the methodology.
- Conditions
- Surgical Site Infection
- Being tested
- application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection
- Keywords
- surgical site infection, vancomycin
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infectionDrug
on the application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection at La Paix State University Hospital Haiti over 2 years.Both groups benefited from the same preoperative asepsis protocol. One hour before the incision, 1g of intravenous ceftriaxone is administered to the patients, this dose is maintained during the 48 hours postoperative every 12 hours. At discharged the two groups of patients received oral cloxacilin 500mg three times a day for one week. Patients are dressed every 2 days until the surgical wound has healed. Patients are seen in the outpatient clinic at 2, 4, and 6 weeks, then at one year. We selected 215 patients and retained 204.
| Study group | Role | What they receive |
|---|---|---|
| expose | Experimental | A group of patients receiving 1g of powdered vancomycin in the operative wound before its closure, and another group not receiving it Receives: Drug: application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection |
| non expose | No intervention | A group of patients not receiving 1g of powdered vancomycin in the operative wound before its closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crossover between ISOs and the two study groups
Crossover Chi Square between ISOs and the two study groups. the significant value of p=0.005.
Measured: 12 month
age
age: quantitative variable the age written on the national identification card Average age =(sum of study ages)/(number of study patients)
Measured: 12 month
sexe
this variable is qualitative and has three modalities 1) male 2) female 3) orther frequency sex X = Number of cases of X / number of total cases Sexeratio=(majority sex)/(minority sex)
Measured: 12 month
origin
qualitative variable. the place where the patient lives. frequency origin X = Number of cases of X / number of total cases this variable has 2 modalities: 1 patient from the capital 2) patient from outside of the capital
Measured: 12 month
comorbidity
qualitative variable. Association of two diseases, mental or physical, frequently observed in the population frequency comorbidity X = Number of cases of X / number of total cases
Measured: 12 month
habits
qualitative variable. mores, customs, customs specific to the patient frequency comorbidity X = Number of cases of X / number of total cases this variable has 2 modalities 1) alcoholic 2)smoker
Measured: 12 month
type of surgery
the surgical technique used this variable qualitative has 6 modality (nail, plate, prothesis, DHS, pinning, vissage, cerclage) frequency X = Number of cases of X / number of total cases
Measured: 12 month
Timing of the surgery
the surgical timing :the time elapsed between the incision and the closure of the skin this variable qualitative has 3 modality ; Less than 1 h ;1 to 2h ; More than 2h
frequency X = Number of cases of X / number of total cases
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start10 Oct 2019
- Primary completion10 Oct 2021
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Surgical Site 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
- Model description
- the randomization sequence was created using Stata 9.0 ware statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4 and 6." "Participants were randomly assigned following simple randomization procedures to 1 of 2 treatment groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ortos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Augustin Delange Hendrick, Clinique Ortos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535725
- Sponsor's protocol ID
- CliniqueOrtos 0590
- Status last verified
- Sep 2022
- First submitted
- 7 Aug 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calderone 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 8539047Graf 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 21404004Sweet 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 21304438Zebala LP, Chuntarapas T, Kelly MP, Talcott M, Greco S, Riew KD. Intrawound vancomycin powder eradicates surgical wound contamination: an in vivo rabbit study. J Bone Joint Surg Am. 2014 Jan 1;96(1):46-51. doi: 10.2106/JBJS.L.01257.
PubMed 24382724O'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 21600853Molinari 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 22160172
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blinded Randomized Clinical Trial on the Application of Powdered Vancomycin in the Surgical Wound as Prophylaxis Against the Occurrence of Surgical Site Infection at La Paix State University Hospital Haiti
- ClinicalTrials.gov ID
- NCT05535725
- Acronym / sponsor ID
- CliniqueOrtos 0590
- Conditions
- Surgical Site Infection
- Keywords
- surgical site infection, vancomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Clinique OrtosUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 10 Sep 2022 (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.
Vancomycin, a tricyclic glycopeptide antibiotic, was originally indicated for the treatment of penicillin-resistant S. Aureus. It has a bactericidal action, inhibiting the biosynthesis of the cell wall of Gram-positive bacteria. Various studies have reported the application of intraoperative vancomycin powder to the wound prior to wound closure as a method of antibiotic prophylaxis. Intrasite administration of the drug should theoretically minimize rapid absorption into the systemic circulation, thereby reducing drug-associated side effects. The precipitated concentration gradient between the local wound and the scaffold should also reduce the occurrence of drug resistance. In Haiti, monitoring patients post-operatively is often difficult. The Mortality, Morbidity and Use of Services Survey (EMMUS-VI 2016-2017) reports that the non-use of a health facility is motivated in 58% of cases by the excessively high economic cost of care. Also, SSIs represent a challenge for clinicians. The best solution to the consequences of SSI in this context is prevention. In the present study, the investigator tested the hypothesis that the use of vancomycin powder in the surgical wound would decrease the occurrence of SSI.
Detailed description
Type of study
This is a single-center prospective study with balanced blind randomization 1: 1 in parallel group.
Method and materials
After approval of the research protocol by the hospital ethics committee, the randomization sequence will be created using Stata 9.0 ware statistical software and will be stratified by center with a 1:1 allocation using random block sizes of 2, 4 and 6." "Participants will be randomly assigned following simple randomization procedures to 1 of 2 treatment groups. A group of patients will receive 2g of powdered vancomycin in the operative wound before its closure, and another group will not receive it. Both groups will benefit from the same preoperative asepsis protocol. One hour before the incision, 1g of intravenous ceftriaxone will be administered to the patients, this dose is maintained during the 48 hours postoperative every 12 hours. At discharged the two groups of patients will receive oral cloxacilin 500mg three times a day for one week. Patients are dressed every 2 days until the surgical wound has healed. Patients will be seen in the outpatient clinic at 2, 4, and 6 weeks, then at one year.
The significance level for the statistical tests is 0.05%. investigator used chi-square tests to assess the degree of relationship. The frequency of the patient's demographic, clinical and therapeutic characteristics are calculated. We used pubmed, google scholar, medline to perform the literature review. The consort guide will be used for the methodology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- the randomization sequence was created using Stata 9.0 ware statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4 and 6." "Participants were randomly assigned following simple randomization procedures to 1 of 2 treatment groups
| Arm | Type | Receives |
|---|---|---|
| expose | Experimental | Drug: application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infectionA group of patients receiving 1g of powdered vancomycin in the operative wound before its closure, and another group not receiving it |
| non expose | No intervention | –A group of patients not receiving 1g of powdered vancomycin in the operative wound before its closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with 18 years and older
- lower extremity fractures
Key exclusion criteria (5 listed)
- patients with impaired consciousness,
- those with an open Gustillo and Anderson type III fracture
- those with a C reactive protein > 6.
- those with date of trauma more than 48 hours
- those with passage of purulent secretion in the wound
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 |
|---|---|---|
| application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infectionon the application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection at La Paix State University Hospital Haiti over 2 years.Both groups benefited from the same preoperative asepsis protocol. One hour before the incision, 1g of intravenous ceftriaxone is administered to the patients, this dose is maintained during the 48 hours postoperative every 12 hours. At discharged the two groups of patients received oral cloxacilin 500mg three times a day for one week. Patients are dressed every 2 days until the surgical wound has healed. Patients are seen in the outpatient clinic at 2, 4, and 6 weeks, then at one year. We selected 215 patients and retained 204. | Drug | expose |
Primary outcome
Crossover between ISOs and the two study groups
Time frame: 12 month
Crossover Chi Square between ISOs and the two study groups. the significant value of p=0.005.
age
Time frame: 12 month
age: quantitative variable the age written on the national identification card Average age =(sum of study ages)/(number of study patients)
sexe
Time frame: 12 month
this variable is qualitative and has three modalities 1) male 2) female 3) orther frequency sex X = Number of cases of X / number of total cases Sexeratio=(majority sex)/(minority sex)
origin
Time frame: 12 month
qualitative variable. the place where the patient lives. frequency origin X = Number of cases of X / number of total cases this variable has 2 modalities: 1 patient from the capital 2) patient from outside of the capital
comorbidity
Time frame: 12 month
qualitative variable. Association of two diseases, mental or physical, frequently observed in the population frequency comorbidity X = Number of cases of X / number of total cases
habits
Time frame: 12 month
qualitative variable. mores, customs, customs specific to the patient frequency comorbidity X = Number of cases of X / number of total cases this variable has 2 modalities 1) alcoholic 2)smoker
type of surgery
Time frame: 12 month
the surgical technique used this variable qualitative has 6 modality (nail, plate, prothesis, DHS, pinning, vissage, cerclage) frequency X = Number of cases of X / number of total cases
Timing of the surgery
Time frame: 12 month
the surgical timing :the time elapsed between the incision and the closure of the skin this variable qualitative has 3 modality ; Less than 1 h ;1 to 2h ; More than 2h frequency X = Number of cases of X / number of total cases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- 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 21404004Graf 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.
- 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 24382724Zebala LP, Chuntarapas T, Kelly MP, Talcott M, Greco S, Riew KD. Intrawound vancomycin powder eradicates surgical wound contamination: an in vivo rabbit study. J Bone Joint Surg Am. 2014 Jan 1;96(1):46-51. doi: 10.2106/JBJS.L.01257.
- 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 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.
- Individual participant dataSharing planned: No
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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 application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection in people with Surgical Site Infection, run by Clinique Ortos at 1 site in Haiti.
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 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. 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 Haiti. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crossover between ISOs and the two study groups (time frame: 12 month). The study lists 8 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 NCT05535725, which also lists 6 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 Sep 2022.