Negligible Systemic Uptake of Suprafascial Vancomycin Powder Following Instrumented Posterior Spinal Fusion-Preliminary Results From A Randomized Clinical Trial (VANCO Trial).

Schär, Ralph T.; Jesse, C. Marvin; Montalbetti, Matteo; Söll, Nicole; Lutz, Katharina; Steinsiepe, Valentin; Branca, Mattia; Raabe, Andreas; Zimmerli, Stefan (2021). Negligible Systemic Uptake of Suprafascial Vancomycin Powder Following Instrumented Posterior Spinal Fusion-Preliminary Results From A Randomized Clinical Trial (VANCO Trial). Neurosurgery, 89(6), pp. 967-972. Lippincott Williams & Wilkins 10.1093/neuros/nyab362

[img]
Preview
Text
Sch_r_Neurosurg_2021_AAM.pdf - Accepted Version
Available under License Publisher holds Copyright.

Download (567kB) | Preview
[img] Text
Sch_r_Neurosurgery_2021.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (826kB)

BACKGROUND

Intrawound vancomycin powder is an emerging strategy to reduce surgical site infections (SSIs) in spine surgery. However, there are concerns relating to its safety profile and toxicity. Data on systemic uptake of suprafascially administered vancomycin powder following instrumented spinal fusion is lacking.

OBJECTIVE

To study the systemic uptake and safety of suprafascially administered vancomycin powder in the early postoperative phase following open instrumented posterior spinal fusion.

METHODS

This was a substudy of an ongoing randomized clinical trial. Eligible adult patients were randomized 1:1 to either receive suprafascial vancomycin powder before wound closure or not to receive vancomycin powder. Serum vancomycin levels were assessed on postoperative days 1 and 2, serum creatinine levels were measured pre- and post-operatively. Adverse events up to 6 wk following surgery were recorded.

RESULTS

Among 34 randomized patients (mean age 62 yr, range 31-84 yr; 18 [53%] women), 17 received vancomycin powder. No detectable serum vancomycin levels (>4.0 mg/L) were found. Proportion of adverse events per patient in the vancomycin and control group, respectively, were 29.4% (5/17) vs 11.8% (2/17) (OR 3.12; 95% CI, 0.52; 19.38; P = .398). No patient had nephrotoxicity or ototoxicity in either group.

CONCLUSION

Suprafascial vancomycin powder in open instrumented spinal fusion surgery is safe and results in negligible systemic uptake. Final results of the VANCO Trial need to be awaited for conclusive data on the efficacy of vancomycin for SSI prevention and its impact on wound healing.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Infectiology
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurosurgery

UniBE Contributor:

Schär, Ralph Thomas, Jesse, Christopher Marvin, Montalbetti, Matteo Luigi, Soell, Nicole, Lutz, Katharina Sarah Jennifer, Steinsiepe, Valentin Klaus, Branca, Mattia, Raabe, Andreas, Zimmerli, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0148-396X

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Annelies Luginbühl

Date Deposited:

23 Sep 2021 12:30

Last Modified:

20 Feb 2024 14:16

Publisher DOI:

10.1093/neuros/nyab362

PubMed ID:

34528089

Uncontrolled Keywords:

Adverse drug reaction Spinal fusion Spine surgery Surgical site infection Vancomycin powder

BORIS DOI:

10.48350/159475

URI:

https://boris.unibe.ch/id/eprint/159475

Actions (login required)

Edit item Edit item
Provide Feedback