A Novel Treatment for Giant Congenital Melanocytic Nevi Combining Inactivated Autologous Nevus Tissue by High Hydrostatic Pressure and a Cultured Epidermal Autograft: First-in-Human, Open, Prospective Clinical Trial

Abstract

This trial is registered on the University Hospital Medical Information Network, identification nos. UMIN000020732 (https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view. cgi?recptno=R000022198) and UMIN000020908 (https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view. cgi?recptno=R000022465).

Surgery or Not? A Systematic Review of Facial Congenital Melanocytic Nevi Treatment Patterns and Outcomes

“…After the removal of 210 duplicates and 160 irrelevant studies, 167 full-text articles were assessed for eligibility, of which 23 met inclusion criteria. The included studies were then cross-referenced and a further 11 studies met the inclusion criteria, totaling 34 included studies for thematic analysis 9–42 . Two additional identified studies did not explicitly report any outcome, aside from complications, and did not include any aesthetic-related information and were excluded 43,44 .…”

“…Two additional identified studies did not explicitly report any outcome, aside from complications, and did not include any aesthetic-related information and were excluded 43,44 . One study did not specify all head and neck anatomic locations but instead, provided three detailed exemplary cases, which we included in the analysis 29 . The predominant design across included studies was case reports (41%), followed by nonrandomized single-arm studies (21%), retrospective chart reviews (18%), case series (15%), prospective clinical trials (3%), and nonrandomized triple arm study (3%) (Table 1).…”

“…Within the included studies, 53% reported on a conservative treatment modality, 9,[13][14][15]18,19,[22][23][24][25][26]30,32,33,35,39,41,42 44% reported on surgical excision of FCMN, [10][11][12]16,17,20,21,[27][28][29]31,34,36,38,40 and 3% used a combined, surgical and conservative treatments. 37 Following surgical excision, 27% of studies reported reconstruction using a flap, and 21% used a full-thickness skin graft (FTSG).…”

“…The majority of postoperative evaluations of surgical treatment outcomes used clinical assessment without a standardized scale (93%). The remaining 2 studies utilized 2 different scales in their evaluation including the Vancouver Scar Scale and the Commission Internationale de I'Eclairage L*a*b* Color Space Evaluation, 29 and a 5-point parental satisfaction scale and a clinical response quartile grading scale. 37 Approximately 22% of all patients experienced a complication, including patients with multiple complications (Fig.…”

Proteins in Wonderland: The Magical World of Pressure

“…For the case of amyloidosis in human tissues, we might need to invent some new technologies for pressurizing a selective portion of the tissue or the fluid directly. Otherwise, the target tissue or fluid could be temporarily removed from the patient’s body and returned after treatment with pressure, as partly realized for the eradication of malignant melanoma [ 32 ].…”