Application of Powdered Vancomycin in the Surgical Wound in Haiti

NCT ID: NCT05535725

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2022-04-05

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.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

expose

A group of patients receiving 1g of powdered vancomycin in the operative wound before its closure, and another group not receiving it

Group Type: EXPERIMENTAL

application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection

Intervention Type: DRUG

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.

non expose

A group of patients not receiving 1g of powdered vancomycin in the operative wound before its closure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

application of powdered vancomycin in the surgical wound as prophylaxis against the occurrence of surgical site infection

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinique Ortos

OTHER

Sponsor Role: lead

Responsible Party

Augustin Delange Hendrick

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cliniques Orthos

Port-au-Prince, , Haiti

Countries

Haiti

References

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.

Reference Type: BACKGROUND

PMID: 8539047 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21404004 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21304438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24382724 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21600853 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22160172 (View on PubMed)

Other Identifiers

CliniqueOrtos 0590

Identifier Type: -

Identifier Source: org_study_id