Treatment of adult spinal deformity

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Vancomycin-impregnated calcium sulfate beads compared with vancomycin powder in adult spinal deformity patients undergoing thoracolumbar fusion

 

Key points

    • ✔ Retrospective study of 95 adult spinal deformity patients comparing the prophylactic use of vancomycin-impregnated STIMULAN beads to vancomycin powder in preventing postoperative surgical site infections (SSI).
    • ✔ There was one SSI in the STIMULAN group (1.9%) and four SSI in the vancomycin powder group (9.5%, p=0.09)
    • ✔ There was no reported seroma or drainage. There were 3 instances of acute kidney injury, 1 in the bead group and 2 in the powder group. All resolved within 3 days.
    • ✔ Study limitations include retrospective, non-randomized design, small sample size, and non-concurrent protocols.

 

Summary

A retrospective review of 95 consecutive patients who underwent thoracolumbar fusion for adult spinal deformity (ASD) by a single surgeon was published by Xiong G. et al. (2021) in “Vancomycin-impregnated calcium sulfate beads compared with vancomycin powder in adult spinal deformity patients undergoing thoracolumbar fusion”. This study compared the intraoperative, prophylactic use of vancomycin-impregnated calcium sulfate beads (STIMULAN) to vancomycin powder in the prevention of surgical site infection (SSI) following thoracolumbar fusion for ASD. Of the 95 patients included, 53 received vancomycin-loaded calcium sulfate beads and 42 vancomycin powder. All patients received standard systemic antibiotic prophylaxis preoperatively as well as postoperatively every 8 hours for 24 hours. Baseline demographics showed that those in the bead group were older (67.8 vs. 59.8 years, p < 0.01) and had a significantly higher number of levels operated on (11.3 vs. 9.1 levels, p =0.03). Both groups had similar BMI, rates of diabetes, smoking status, and length of surgery.

There were 5 total postoperative SSIs with 4 in the powder group and 1 in the bead group (9.5% vs 1.9%, p = 0.09). All reported infections occurred within the first 90 days after surgery. The patient in the bead group who developed an SSI had non-insulin-dependent diabetes, a BMI of 43.9 kg/m², and a Klebsiella pneumoniae infection. Of the 4 cases in the powder group, 2 were posterior spinal fusion revision cases with one of these patients also having a history of prior periprosthetic joint infection (PJI) of the knee. A third patient in the powder group had a diagnosis of Crohn’s disease. There were no reported seromas or drainage in either group. Postoperative acute kidney injury in the first 30 days after surgery was observed in 2 patients in the powder group and 1 patient in the bead group. All episodes were resolved within 3 days. The patient in the bead group had stage 3 chronic kidney disease at baseline and received 4 grams of intravenous vancomycin in addition to 2 grams via calcium sulfate beads.

The authors concluded that inclusion of vancomycin-impregnated calcium sulfate beads trends towards lower rates of surgical site infection than vancomycin powder in patients undergoing thoracolumbar fusion for adult spinal deformity. Study limitations include small sample size, non-randomized, retrospective analysis with consecutive protocols rather than concurrent with powder being used up until 2018 when surgeon switched to beads.

Publication
https://www.nassopenaccess.org/article/S2666-5484(20)30048-2/fulltext

Statements

Key Points and Summary prepared by Biocomposites Ltd. The new/unapproved uses of STIMULAN described in this scientific article have not been approved/cleared by the (US) FDA and the safety and effectiveness for the new/unapproved use has not been established.

The (US) FDA approved/cleared use of SIMULAN is available here. These Instructions for Use specify the approved/cleared intended use, indications, contraindications, warnings and precautions.