High energy, double pass helium plasma dermal resurfacing: A prospective, multicenter, single-arm clinical study.

BACKGROUND: A previous multi-center clinical study of low energy (20% power), single-pass helium plasma dermal resurfacing (HPDR) showed positive results but did not fully reveal the true potential of this novel technology. A second multi-center clinical study, reported herein, was therefore undertaken to evaluate efficacy and safety of high energy (40%), double pass HPDR for treatment of facial rhytids (ClinicalTrials.gov Identifier: NCT04185909). METHODS: Fifty-five eligible subjects seeking improvement in facial rhytids were enrolled for study at one of four investigational sites. All subjects underwent full-face HPDR treatment. The forehead, nose, cheeks, and peri-oral treatment zones were treated at 40% power with two passes whereas the peri-orbital and jawline/mandibular zones were treated at 20% power (up to 40% for jawline/mandibular zone) and one or two passes. Photographic images of the face were captured using the VISIA-CR system. Three-month posttreatment Fitzpatrick Wrinkle and Elastosis Scale (FWS) scores were compared to baseline scores as determined by blinded independent photographic reviewers (IPRs) and study investigators. RESULTS: Blinded IPRs and study investigators observed a ≥1-point FWS improvement in 100% of subjects with mean change in IPR FWS from baseline to the 90-day visit of -3.6 (±1.2). 96.4% of subjects indicated "improvement" in appearance at the 90-day visit utilizing the modified Global Aesthetic Improvement Scale. Evaluation of VISIA-CR data revealed statistically significant improvements in wrinkles, brown spots, and pore counts. Overall, 269 Adverse Events in 55 subjects were reported; most were mild-moderate in severity (99.3%), anticipated (86.2%), and of relatively short duration with most having resolved within 30 days (60.6%) of treatment. CONCLUSION: Treatment of facial rhytids with high energy, double pass HPDR as detailed herein enables a marked improvement in FWS that parallels or surpasses competing technologies. VISIA-CR analysis demonstrates additional improvements in skin quality with statistically significant quantitative improvements in brown spots and enlarged pores as well as wrinkles. Effective rhytid effacement combines with high subject satisfaction and few unanticipated adverse events for a reasonable benefit-risk ratio.

A Single-site Postmarket Retrospective Chart Review of Subdermal Coagulation Procedures with Renuvion.

Although tumescent liposuction provides debulking of body areas with excess subcutaneous fat and concurrent skin laxity, the ability to shrink and redrape the skin and soft tissue for added definition has remained an elusive goal. Many modalities employed to facilitate fat removal utilizing light energy, ultrasonic energy, or radiofrequency energy have provided modest skin shrinkage. Apyx Medical's (formerly Bovie Medical) Renuvion (previously branded as J-Plasma) has Food and Drug Administration clearance for the cutting, coagulation, and ablation of soft tissue. The objective of this retrospective chart review was to collect safety and procedural information for patients who have previously undergone liposuction with which Renuvion was used as a tool for subdermal coagulation. All procedures occurred before August 2018. Thirty-two patients were identified (3 male and 29 female). The mean follow-up was 6 months (range, 3-8 months). None of the patients required a revision or secondary procedure suggesting 100% of patients had acceptable final outcomes. No device-related adverse events or complications were noted, suggesting that within this data set, Renuvion's unique cool helium plasma technology can safely be used for skin contraction with or without tumescent liposuction or supplemental modalities used to facilitate fat removal that may otherwise contribute to the skin contraction.

Survival of long nerve allografts following donor antigen pretreatment: a pilot study.

In this study, the authors evaluated whether the pretransplant portal venous administration of UV-B irradiated donor alloantigen would induce tolerance to long peripheral nerve allografts in a swine model. They completed nerve allograft transplantation between four swine of separate lineages. Regeneration across the nerve allografts was followed for 10 months postoperatively. Sequential IN VITRO assays demonstrated the successful and prolonged suppression of the recipient immune response to donor antigen following antigen inoculation. Histomorphometric analysis demonstrated successful regeneration across the long nerve allografts in the pretreated recipients, but not across allografts in unimmunosuppressed recipients. A single pretransplant antigen delivery protocol has the potential to replace chronic medicinal immunosuppressant therapy and its associated morbidities. Furthermore, tolerance to long nerve allografts has immediate applicability to clinical requirements for bridging multiple, complex, long nerve gaps.

Immune unresponsiveness by intraportal UV-B-irradiated donor antigen administration requires persistence of donor antigen in a nerve allograft model.

The purpose of this study was to characterize the mechanism of unresponsiveness produced by the intraportal administration of ultraviolet-B (UV-B)-irradiated donor antigen. Pretreated Buffalo rats accepted Lewis nerve allografts, had decreased in vitro T-cell reactivity, and demonstrated nerve regeneration and recovery of limb function, while rejecting third-party nerve allografts. Regenerated nerve grafts were then retransplanted into a second naïve recipient. Rejection of the retransplanted allograft by naïve donor-strain, but not recipient-strain, animals suggests that the allografts were completely replaced by host tissue. Pretreated Buffalo rats were also given a second Lewis allograft after the first had regenerated. The second allograft was rejected and in vitro immune reactivity was comparable to naïve animals. Because the unresponsiveness state was extinguished with loss of exposure to donor antigen, these findings suggest that the intraportal administration of UV-B-irradiated donor antigen works by anergic or suppressive regulatory, rather than deletional, mechanisms.

Effect of nondepleting anti-CD4 monoclonal antibody (Rib 5/2) plus donor antigen pretreatment in peripheral nerve allotransplantation.

Peripheral nerve allotransplantation allows the reconstruction of injuries with long nerve gaps that are otherwise unsalvageable. In this study, the efficacy of anti-CD4 monoclonal antibody (mAb) combined with donor antigen pretreatment in prolonging the survival of short peripheral nerve allografts was investigated in a rodent model. Such an approach could potentially avoid the need for systemic immunosuppression and its concomitant morbidities. Buffalo rats received either nerve isografts or nerve allografts from Lewis rats. Untreated isograft and allograft groups were used as controls. Allograft recipients received either a single dose of RIB 5/2, a nondepleting anti-CD4 mAb, a single dose of Lewis splenocytes, or both antigen and RIB 5/2, 7 days prior to transplantation. Flow cytometric analysis verified that the T-lymphocyte population was maintained, while CD4 expression was downregulated by RIB 5/2. Histologic evaluation demonstrated better regeneration in the allograft recipients receiving both donor antigen and antibody, compared to recipients of untreated allografts or treatment with antigen or antibody alone.

Acceleration of peripheral nerve regeneration following FK506 administration.

Purpose: The severe functional and sensory deficits seen following injury to peripheral nerves makes facilitation of nerve regeneration a primary goal of the reconstructive surgeon. This study examines whether daily administration of FK506 or Cyclosporin A expedites peripheral nerve regeneration following neurotmetic injury in a rat model Methods: Inbred Buffalo rats were randomized to three experimental groups. Group I rats served as untreated controls. Rats in groups II and III received daily subcutaneous CsA (5 mg/kg), and FK506 (1 mg/kg), respectively. Each animal underwent unilateral posterior tibial nerve transection with immediate epineurial reapproximation. Functional recovery of the injured limb was assessed by serial walking track analysis. Nerve regeneration was assessed histomorphometrically via light microscopy. Results: Return of hindlimb function in control animals occurred at 32 days post injury. CsA and FK506-treated transection animals recovered at 26 and 18 days post injury, respectively. Statistically significant greater fiber density and percent neural tissue were seen in FK506- treated animals compared to control animals four weeks post transection. Conclusions: This data suggest that the daily systemic administration of both CsA and FK506 accelerate the rate of functional regeneration, following neurotmetic injuries in tbc rat model. FK506's effect on nerve growth is significantly greater than that of CsA.

Decreased Cyclosporin A requirement with anti-ICAM-1 and anti-LFA-1 in a peripheral nerve allotransplantation model.

OBJECT: This study evaluated the dose related effects of Cyclosporin A (CsA) alone and in combination with monoclonal antibodies (mAbs) directed against intercellular adhesion molecule-1 (ICAM-1) and the alpha subunit of leukocyte function-associated antigen (LFA-1 ) on peripheral nerve allograft rejection in a rat model. METHODS: Nerve regeneration was assessed using gait analysis of returning hind limb function, histology, and morphometry. RESULTS: Regeneration comparable to isograft controls and high dose CsA treatment groups was observed when mAbs were used in combi-nation with intermediate dose CsA. Intermediate dose CsA therapy without additional mAbs was insufficient to support this level of regeneration. Nerve allografts treated with high and low dose CsA demonstrated no increased benefit with the addition of mAb therapy. CONCLUSIONS: Thus, mAbs seem to have a dose dependent effect on immunosuppression when used in combination with CsA, and may have therapeutic promise as a rescue therapy when CsA levels fall or issues of toxicity become important.