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J Neurosurg Spine. 2018 Nov 1;29(5):553-559. doi: 10.3171/2018.3.SPINE171111.

A double-blind randomized controlled trial of the local application of vancomycin versus ampicillin powder into the operative field for thoracic and/or lumbar fusions.

Author information

1
1Spine Center.
2
Departments of2Neurological Surgery and.
3
5Department of Spine Surgery, Aichi Spine Hospital, Inuyama, Aichi, Japan.
4
3Orthopedics Surgery; and.
5
4Division of Biostatistics, Clinical Research Center, Aichi Medical University Hospital, Nagakute; and.

Abstract

OBJECTIVERetrospective studies have reported that the local application of vancomycin (VCM) powder into the operative field decreases the incidence of surgical site infection (SSI) in thoracic and/or lumbar fusion. Authors of the present study prospectively evaluated the effects of VCM in patients undergoing thoracic and/or lumbar fusion.METHODSIn this randomized double-blind trial, 230 patients undergoing thoracic and/or lumbar fusion were randomly assigned to the local administration of VCM (interventional group, 1 g) or ampicillin (AMP; control group, 1 g) into the surgical field. The primary outcome was SSI results within 1 year of surgery.RESULTSThe trial was prematurely stopped according to predetermined rules. The results showed one superficial infection (0.9%, Staphylococcus aureus) and one deep infection (0.9%, S. aureus) in the VCM group and two superficial infections (1.8%, Staphylococcus epidermidis and culture negative) and one deep infection (0.9%, methicillin-resistant S. aureus) in the AMP group. No significant differences in infection rates were observed between the groups (p = 0.8).CONCLUSIONSThis double-blind randomized controlled trial demonstrated that the local application of VCM or AMP powder into the operative field in short thoracic and/or lumbar fusion procedures resulted in a similar incidence of SSI.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III.Clinical trial registration no.: UMIN000009377 (umin.ac.jp/ctr).

KEYWORDS:

AMP = ampicillin; JOABPEQ = Japanese Orthopaedic Association Back Pain Evaluation Questionnaire; MRSA = methicillin-resistant Staphylococcus aureus; QOL = quality of life; RCT = randomized controlled trial; SA = Staphylococcus aureus; SE = Staphylococcus epidermidis; SSI = surgical site infection; Staphylococcus epidermidis; VCM = vancomycin; methicillin-resistant Staphylococcus aureus; quality of life; surgical site infection; vancomycin

PMID:
30095381
DOI:
10.3171/2018.3.SPINE171111
[Indexed for MEDLINE]

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