Do Antibiotic-impregnated Calcium Sulfate Beads Improve the Healing of Neuropathic Foot Ulcers With Osteomyelitis Undergoing Surgical Debridement?

BACKGROUND: Neuropathic foot ulcers are common and difficult to treat. Calcium sulfate (CAS) has been used for antibiotic delivery in the treatment of osteomyelitis with success. Recent case series suggest success in treating osteomyelitis of the foot with CAS in a mean time to healing of 4 months; however, few studies with a control group for comparison exist. OBJECTIVE: This study aims to determine if antibiotic-impregnated CAS beads improved the healing of neuropathic foot ulcers with proven osteomyelitis undergoing surgical debridement. MATERIALS AND METHODS: A consecutive retrospective cohort study of 50 patients undergoing surgical debridement of neuropathic foot ulcers for osteomyelitis from December 2015 to May 2016 was performed. Exclusion criteria consisted of amputations and microbiology findings inconsistent with osteomyelitis. Patients were divided into 2 groups: the surgical debridement (SD) group was treated with SD alone and the other (CAS) was treated with debridement and implantation of vancomycin- and gentamicin-impregnated CAS beads. RESULTS: After exclusion criteria, 42 patients were included: 13 in the SD group and 29 in the CAS group. In the SD group, the mean time to healing was 5.8 months (range, 2-9 months), and in the CAS group, it was 5.5 months (range, 2-13 months). There was no significant difference in ulcer healing (P = .81), time to healing (P = .79), reoperation rate (P = .51), length of stay (P = .74), or mortality (P = .13) between the 2 groups. CONCLUSIONS: Ulcer healing in patients treated with antibiotic-impregnated CAS beads did not show statistical significance. Healing rates in both groups were similar to those in recent literature. Surgical debridement alone may be as effective as supplementation with local antibiotics in a bioabsorbable carrier.

Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

BACKGROUND: Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks' immobilisation in a below-knee cast. METHOD/DESIGN: We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. DISCUSSION: The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external validity. Accordingly, if significant clinical benefits and cost-effectiveness are demonstrated, EMADE should become a worthwhile treatment option. A larger-scale, multicentre trial may be required to influence national guidelines. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN11212729 . Registered retrospectively on 20 March 2017.