Application of Powdered Vancomycin in the Surgical Wound in Haiti
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Phase 4
Locations
Haiti
Study Type
Interventional
Intervention
application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring surgical site infection, vancomycin
Eligibility Criteria
Inclusion Criteria:
- patients with 18 years and older
- lower extremity fractures
Exclusion Criteria:
- 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
Sites / Locations
- Cliniques Orthos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
expose
non expose
Arm Description
A group of patients receiving 1g of powdered vancomycin in the operative wound before its closure, and another group not receiving it
A group of patients not receiving 1g of powdered vancomycin in the operative wound before its closure
Outcomes
Primary Outcome Measures
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.
age
age: quantitative variable the age written on the national identification card Average age =(sum of study ages)/(number of study patients)
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)
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
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
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05535725
Brief Title
Application of Powdered Vancomycin in the Surgical Wound in Haiti
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 10, 2021 (Actual)
Study Completion Date
April 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Ortos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
surgical site infection, vancomycin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
expose
Arm Type
Experimental
Arm Description
A group of patients receiving 1g of powdered vancomycin in the operative wound before its closure, and another group not receiving it
Arm Title
non expose
Arm Type
No Intervention
Arm Description
A group of patients not receiving 1g of powdered vancomycin in the operative wound before its closure
Intervention Type
Drug
Intervention Name(s)
application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Crossover between ISOs and the two study groups
Description
Crossover Chi Square between ISOs and the two study groups. the significant value of p=0.005.
Time Frame
12 month
Title
age
Description
age: quantitative variable the age written on the national identification card Average age =(sum of study ages)/(number of study patients)
Time Frame
12 month
Title
sexe
Description
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)
Time Frame
12 month
Title
origin
Description
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
Time Frame
12 month
Title
comorbidity
Description
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
Time Frame
12 month
Title
habits
Description
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
Time Frame
12 month
Title
type of surgery
Description
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
Time Frame
12 month
Title
Timing of the surgery
Description
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
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with 18 years and older
lower extremity fractures
Exclusion Criteria:
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
Facility Information:
Facility Name
Cliniques Orthos
City
Port-au-Prince
ZIP/Postal Code
ht6144
Country
Haiti
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8539047
Citation
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.
Results Reference
background
PubMed Identifier
21404004
Citation
Graf 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.
Results Reference
background
PubMed Identifier
21304438
Citation
Sweet 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.
Results Reference
background
PubMed Identifier
24382724
Citation
Zebala 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.
Results Reference
background
PubMed Identifier
21600853
Citation
O'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.
Results Reference
background
PubMed Identifier
22160172
Citation
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.
Results Reference
background
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Application of Powdered Vancomycin in the Surgical Wound in Haiti
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