Role of STIMULAN in chronic osteomyelitis-A randomised blinded study on 95 patients comparing 3 antibiotic compositions, bead quality, forming & absorption time.

INTRODUCTION

Chronic Osteomyelitis is a well-known clinical entity affecting patients holistically and presents with multiple treatment challenges. Local antibiotic delivery with biodegradable drug carriers has shown promising results.

MATERIALS AND

METHODS

Prospective multicenter study performed at 2 centers from November 2021 to January 2023 on 95 osteomyelitis patients treated with surgical debridement & STIMULAN™ for local antibiotic delivery. Patients were randomized into 3 groups. Authors compared antibiotic combinations, bead quality, bead setting, and resorption time for calcium sulfate beads- STIMULAN™. Additionally, organisms isolated, WBC Turnover time, Hypersensitivity Reactions, Recurrence, and Revision Rates were documented.

RESULTS

95 patients underwent surgical debridement and STIMULAN™ bead application for chronic osteomyelitis. The proximal 1/3rd tibia was commonly affected. The most common symptoms were sinus and pus discharge in 96.84 % & 86.31 % of patients respectively (p < 0.001). Staphylococcus aureus & MRSA were isolated in 37.8 % & 29.4 % of the patient's wound culture respectively. Bead setting time in Descending order was Group 3 > Group 2 > Group 1 (p < 0.001). Bead setting first in Group 1 followed by Group 3 & 2. On compression, Group-1 beads withstood maximum compression forces & had smooth even bead surfaces. On radiographs, 1/3rd bead volume in ascending order was Group 3 > Group 2 > Group 1 (p < 0.001). 2/3rd reduction in ascending order was Group 3 > Group 2 > Group 1. Complete bead absorption was earliest seen in Group 3 followed by Group 2 & Group 1 (p < 0.001). Recurrence in 2 patients (Group 2) at 6 weeks. Revision rate: 2.10 %. There were no incidences of hypersensitivity. Suture removal was done at 16 ± 2 days.

CONCLUSION

STIMULAN™ combination with tobramycin, vancomycin, and gentamycin is stable, and forms uniform beads with predictable drug elution & bead resorption with negligible side effects. A mixture with higher liquid content sets later, forms softer beads, and resorbs earlier.