Dataset Information

A Prospective Study Evaluating the Use of Helium Plasma for Dermal Resurfacing.

ABSTRACT:

Background and objectives

A novel helium plasma device was evaluated for efficacy and safety for dermal resurfacing (ClinicalTrials.gov Identifier: NCT03286283). The helium plasma device delivers energy in a controlled, bimodal fashion that when compared with the nitrogen plasma predicate device in a porcine animal model demonstrated a more limited depth of thermal effect but a greater skin tissue contraction.

Study design/materials and methods

Fifty-five eligible subjects seeking improvement in facial rhytids were enrolled for study at one of three investigational sites. Most subjects underwent full-face treatment. Power levels were limited to 20% at peri-oral and peri-orbital areas-a level that correlates to an energy density 40% lower than the highest setting on the predicate device. Three-month post-treatment Fitzpatrick Wrinkle and Elastosis Scale (FWS) scores were compared with baseline scores as determined by blinded independent photographic reviewers (IPRs) and study investigators.

Results

Blinded IPRs observed a ?1-point FWS improvement in 63.64% of subjects whereas study investigators noted a ?1-point FWS improvement in 54 of 55 subjects (98.18%) of subjects. 90.9% of subjects indicated "improvement" in appearance utilizing the modified Global Aesthetic Improvement Scale. Subgroup analysis showed 1-point (±0.05) FWS improvement by IPRs and study investigators for Fitzpatrick Skin Types II and III, age?62, two of three study sites, and post-treatment oral steroid use. Eighty Non-Serious Adverse Events in 39 subjects were reported, most of which resolved within 14 days or less. There were no Serious Adverse Events or Unanticipated Device Effects reported.

Conclusion

At the modest power level studied, a significant improvement from a single pass helium plasma dermal resurfacing treatment was observable in most subjects by IPRs and investigators, and no serious adverse events were reported. The discrepancy between IPR and study investigator FWS improvement may be explained in part by the limitations of assessing two-dimensional photographs versus live in-person evaluation of subjects. Studies evaluating higher energy levels and/or multiple treatment passes are ongoing. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals, Inc.

SUBMITTER: Holcomb JD

PROVIDER: S-EPMC7754429 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

A Prospective Study Evaluating the Use of Helium Plasma for Dermal Resurfacing.

Holcomb J David JD Kelly Michael M Hamilton Tiffani K TK DeLozier Joseph B JB

Lasers in surgery and medicine 20200429 10

<h4>Background and objectives</h4>A novel helium plasma device was evaluated for efficacy and safety for dermal resurfacing (ClinicalTrials.gov Identifier: NCT03286283). The helium plasma device delivers energy in a controlled, bimodal fashion that when compared with the nitrogen plasma predicate device in a porcine animal model demonstrated a more limited depth of thermal effect but a greater skin tissue contraction.<h4>Study design/materials and methods</h4>Fifty-five eligible subjects seeking ...[more]

PMID: 32350901

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Project description:BackgroundA 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).MethodsFifty-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.ResultsBlinded 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.ConclusionTreatment 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.

Project description:PurposeResurfacing the patella in one-stage bilateral total knee arthroplasty (TKA) remains debatable. This study aimed to assess the mid-term outcomes of patients after one-stage bilateral TKA performed with and without patellar resurfacing, respectively, with at least five years of follow-up.MethodsSixty-six patients (132 knees) scheduled for first-ever one-stage bilateral TKA due to osteoarthritis received patellar resurfacing and retention, respectively, on one knee and the other, randomly selected. All patients received Scorpio NRG knee prostheses and were evaluated by radiology (anteroposterior, lateral, and axial views) pre-operatively and yearly post-operatively, for at least five years. Knee Society Score and Feller Score values were measured. Anterior knee pain, patellar clunk, and patient satisfaction were assessed.ResultsOne patient died within five years of operation and four were lost to follow-up. One patient developed severe dementia and could not be constructively questioned. Therefore, 60 patients (120 knees) were finally analyzed. There were significantly improved Knee Society and Feller scores (P < 0.001) in the resurfacing group compared with the non-resurfacing group post-operatively. Anterior knee pain and patellar clunk rates were lower on the resurfaced side compared with the non-resurfaced side (P < 0.001). Meanwhile, 47% and only 7% patients preferred the resurfaced and non-resurfaced sides, respectively, at final follow-up. No revision was performed for patellofemoral complications, and no significant differences were found between the two groups in radiographic outcomes.ConclusionsUsing the Scorpio NRG knee prosthesis, patellar resurfacing is superior to non-resurfacing in patients with osteoarthritis observed for ≥ five years.Registration trials numberNCT03600922 KEY POINTS: • Findings Patellar resurfacing is superior to non-resurfacing in osteoarthritis (OA) patients undergoing total knee arthroplasty (TKA) with the Scorpio NRG knee prosthesis. • Implications Patellar resurfacing should be performed in OA patients during TKA. • Caution Several prosthesis types should be assessed in the same study setting, and multicenter studies are required before generalizability of the present findings.

Dataset Information

A Prospective Study Evaluating the Use of Helium Plasma for Dermal Resurfacing.

Background and objectives

Study design/materials and methods

Results

Conclusion

Publications

A Prospective Study Evaluating the Use of Helium Plasma for Dermal Resurfacing.

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