Stimulan Presentation Jak Johnston

Company Profile A small example of the products we distribute include the SAMO Trekking Knee (ITALY), Furlong and Furlong Evolution from JRI (UK) Lumbar and cervical prosthesis for Fusion and Disc Replacement Surgeries (FRANCE)

Antibiotic elution from STIMULAN Rapid Cure ™9

Low levels of drainage

Case Study- Use of antibiotic loaded Stimulan Pellets in a Diabetic Foot Ulcer

Presentation 45 year old male, Admin Officer with uncontrolled diabetes. Bilateral leg cellulitis with gross septicemia Blister formation and oozing of fluid. Pain and Redness. Poly-microbial infection with multiple antibiotic resistant gram-negative Bacilli seen Initial I&D done with IV antibiotics administered.(Period-2 weeks) 20 sessions of HBOT with no considerable improvement. Image taken after 3 debridements Surgeon contemplating BKA

Pus oozing from subcutaneous tissue, tendons stiff and de-coloured, pungent foul smell

Following debridement and wash,30cc Stimulan combined with antibiotics was used covering maximum area of the wound. (Colistin 3mu and 240mg Gentamycin per 10cc) A sterile mesh material is used to hold the pellets in place

6mm,4.8mm and 3mm sized stimulan pellets used so as to cover maximum area. Pellets are packed in the subcutaneous tissue as well. Dressing- Saline soaked gauze was used to cover the area followed by normal dressing material.

1 st Dressing done after 48hrs post implantation of Stimulan No pus seen oozing subcutaneously The wound looks dry and reddish pink.

Images taken during 3 rd dressing- Wound is dry with increased vascularity Swabs taken for culture to check for organisms IV antibiotics stopped and oral antibiotics given Patient is discharged and alternate day dressings continue. Surgeon plans to do skin grafting after 3-4 weeks

Wound at 4 weeks post implantation of Stimulan

Wound at 4 weeks post skin-grafting

Questions 1. If you are allergic to sulphate or calcium sulphate can you still implant stimulan into the patient? 2. Do you have to regularly take out the stimulan beads with diabetic ulcers and reimplant them after dressing and washing them out? 3. By using stimulan would you speed the process up of completing a second stage revision in comparison to loading the infection with PMMA spacers or cement beads such as Palacos (gentamicin loaded cement).

Answers 1. No, whilst it is not specifically contraindicated, it would seem wise not to use in these patients. It is contraindicated in patients with hypercalcaemia 2. No, they are generally left in during dressing changes. Wounds are not normally washed out once Stimulan is implanted. As the edges granulate in, beads may be removed from the margins. If beads fall out during dressing changes, some surgeons replace them with new beads 3. As a regulated medical device, all claims that we make have to be backed up by clinical evidence and approved by our regulatory authorities. We are not able to make the claim that Stimulan speeds up the process. However, the delay between first and second stages of a revision procedure is hotly debated and driven by many factors, not just clearance of infection. There is evidence that Gent-loaded beads lose their efficacy after a week or so and biofilm has been isolated on explanted gent-loaded beads (they may become a nidus or host for the infection…). Cement spacers perform a mechanical function that is important in order to retain the integrity of the tissues. However, their purpose is not to remove the infection. Stimulan will help to fill dead space (reducing haematoma formation) whilst releasing very high levels of antibiotics over the whole time they are present in the joint.