Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial Autologous AD-SVF versus placebo in systemic sclerosis.

OBJECTIVE: To assess the superiority of adipose tissue-derived stromal vascular fraction (AD-SVF) injection into the fingers vs placebo in reducing hand disability in systemic sclerosis (SSc) patients. METHODS: We performed a double-blind, multicentre, phase II trial from October 2015 to January 2018 in France. SSc patients with a Cochin Hand Function Scale (CHFS) ≥20/90 were randomized 1:1 to receive injection of AD-SVF or placebo. AD-SVF was obtained using the automated processing Celution 800/CRS system. The placebo was lactated Ringer's solution. The primary efficacy end point was the change of the CHFS score from baseline to 3 months. Secondary efficacy endpoints included the CHFS score at 6 months, hand function, vasculopathy, hand pain, skin fibrosis, sensitivity of the finger pulps, Scleroderma Health Assessment Questionnaire, patients and physician satisfaction, and safety. RESULTS: Forty patients were randomized. The AD-SVF and placebo groups were comparable for age, sex ratio, disease duration, skin fibrosis of the hands and main cause of hand disability. After 3 months' follow-up, hand function significantly improved in both groups with no between-group difference of CHFS (mean change of -9.2 [12.2] in the AD-SVF group vs -7.6 [13.2] in the placebo group). At 6 months, hand function improved in both groups. CONCLUSION: This study showed an improvement of hand function in both groups over time, with no superiority of the AD-SVF. Considering the limits of this trial, studies on a larger population of patients with homogeneous phenotype and hand handicap should be encouraged to accurately assess the benefit of AD-SVF therapy. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02558543. Registered on September 24, 2015.

The Potential Innovative Use of Bacteriophages Within the DAC® Hydrogel to Treat Patients With Knee Megaprosthesis Infection Requiring "Debridement Antibiotics and Implant Retention" and Soft Tissue Coverage as Salvage Therapy.

Infection is the most dramatic complication in patients with knee megaprosthesis. Its management is more complex in comparison with patients with primary arthroplasty, with a high risk of relapse. Lytic bacteriophages are considered to have a high potential in patients with prosthetic joint infection as it has been demonstrated that they have a synergistic anti-biofilm activity with antibiotics. The Defensive Antibacterial Coating (DAC®) hydrogel is a hydrogel available in the market that has been designed to prevent the adherence of bacteria on a prosthetic joint and to have the ability to transport and release anti-bacterial substances such as antibiotics. We report here the case of a patient with a catastrophic relapsing Staphylococcus aureus knee megaprosthesis infection without prosthesis loosening. We firstly perform phage susceptibility testing of the patient's strain to select an active cocktail, under the supervision of the French health authority. Then, we performed, as salvage therapy, a debridement and implant retention procedure with application of a selected cocktail of bacteriophages that was prepared extemporaneously within the DAC® hydrogel. A free flap for soft tissue coverage was required and empirical antibiotic treatment was started immediately after the surgery. Unfortunately, at 5 days after the surgery, while the local aspect of the surgical site was favorable, the patient developed myocardial infarction which required emergency stenting and dual antiplatelet therapy that were rapidly associated with bleeding at the surgical site, leading to a new prosthesis exposition. As a consequence, a transfemoral amputation was finally performed several months later. We also evaluated in vitro the impact of DAC® hydrogel on bacteriophage activity and showed that the selected phages were released very rapidly from the DAC® hydrogel, and then their titers were stable for at least 6 h. This case demonstrated the feasibility of the use of bacteriophages within a hydrogel to treat patients for knee megaprosthesis infection during a debridement procedure. The implementation requires identification of the pathogen before the debridement in order to perform phage susceptibility testing of the patient's strain and to identify a hospital pharmacist who will accept to do the preparation and to take the responsibility of the magistral preparation.

Pressure ulcer-related pelvic osteomyelitis: evaluation of a two-stage surgical strategy (debridement, negative pressure therapy and flap coverage) with prolonged antimicrobial therapy.

BACKGROUND: A two-stage surgical strategy (debridement-negative pressure therapy (NPT) and flap coverage) with prolonged antimicrobial therapy is usually proposed in pressure ulcer-related pelvic osteomyelitis but has not been widely evaluated. METHODS: Adult patients with pressure ulcer-related pelvic osteomyelitis treated by a two-stage surgical strategy were included in a retrospective cohort study. Determinants of superinfection (i.e., additional microbiological findings at reconstruction) and treatment failure were assessed using binary logistic regression and Kaplan-Meier curve analysis. RESULTS: Sixty-four pressure ulcer-related pelvic osteomyelitis in 61 patients (age, 47 (IQR, 36-63)) were included. Osteomyelitis was mostly polymicrobial (73%), with a predominance of S. aureus (47%), Enterobacteriaceae spp. (44%) and anaerobes (44%). Flap coverage was performed after 7 (IQR, 5-10) weeks of NPT, with 43 (68%) positive bone samples among which 39 (91%) were superinfections, associated with a high ASA score (OR, 5.8; p = 0.022). An increased prevalence of coagulase negative staphylococci (p = 0.017) and Candida spp. (p = 0.003) was observed at time of flap coverage. An ESBL Enterobacteriaceae spp. was found in 5 (12%) patients, associated with fluoroquinolone consumption (OR, 32.4; p = 0.005). Treatment duration was as 20 (IQR, 14-27) weeks, including 11 (IQR, 8-15) after reconstruction. After a follow-up of 54 (IQR, 27-102) weeks, 15 (23%) failures were observed, associated with previous pressure ulcer (OR, 5.7; p = 0.025) and Actinomyces spp. infection (OR, 9.5; p = 0.027). CONCLUSIONS: Pressure ulcer-related pelvic osteomyelitis is a difficult-to-treat clinical condition, generating an important consumption of broad-spectrum antibiotics. The lack of correlation between outcome and the debridement-to-reconstruction interval argue for a short sequence to limit the total duration of treatment.

Hand Allograft Saved by an Ultrathin Groin Flap.

We report a case of a young double-hand allotransplant patient who presented with a full-thickness skin necrosis of the dorsum of the left hand after vascular compromise of the allotransplantation. Considering the lack of viable dorsal tissue overlying the extensor tendons and the need for early hand rehabilitation, an ultrathin pedicled groin flap was used for the coverage. This procedure resulted in salvaging the allotransplantation, and the patient was able to successfully return to work after his surgery. To our knowledge, this is the only case of an upper extremity allotransplant salvaged by a pedicled flap.

Costal Grafting in Mandibular Reconstruction.

BACKGROUND: Reconstruction of mandibular bone defect is a common indication in craniomaxillofacial surgery, and free fibular flap is the gold standard for this indication. However, there are alternatives; nonvascular bone grafting is one of them, and we present the costal grafting for mandibular reconstruction, a classic technique that is reliable, efficient, and produced less morbidity than the technique of using composite free flaps. METHOD: A 9-year retrospective review of 54 patients treated surgically for mandibular reconstruction was performed. The criterion mainly analyzed was graft survival. The surgical technique was described in detail. RESULTS: A total of 54 patients with mandibular bone defect were identified. Five symphysis, 46 corpus, and 20 ramus defects were considered. These patients underwent reconstruction by costal grafting, and the engrafting was successful in 92.6% of cases. Dental rehabilitation with dental implants was realized in 70% of cases. CONCLUSIONS: The approach described in this article allowed the authors to obtain good results with costal grafting for mandibular reconstruction and dental rehabilitation. Costal grafting is a good alternative for fibula free flap in specific indications. Reconstruction of mandibular bone defect is a common indication in craniomaxillofacial surgery. Since the 1980s, the gold standard for these defects is the use of free fibular flap.(1) In some cases, this technique is contradicted; the surgeon then has several possibilities for the use of free osteomyocutaneous flaps (iliac crest, scapula, and serrato-costal flaps).(2-8).