Effects of ON101 for Hard-to-Heal Diabetic Foot Ulcers in A Randomized Phase III Trial: A Post hoc Analysis.

OBJECTIVE: Hard-to-heal diabetic foot ulcers (DFUs) are associated with higher mortality rates and an increased medical burden for patients. ON101, a new topical cream, exhibited better healing efficacy than the control dressing in a Phase III trial. In this post-hoc analysis, we further identify whether ON101 can improve the healing of ulcers with hard-to-heal risk factors in this cohort of DFU patients. APPROACH: To compare the efficacy of ON101 with absorbent dressing among various hard-to-heal wounds in patients with DFU, a post hoc analysis of a randomized phase III trial included 276 DFU patients was performed by subgrouping those patients based on ulcer depth, location, size, duration, and patients' glycated hemoglobin (HbA1c) levels and body mass index (BMI). RESULTS: In the full analysis set, the proportion of patients achieving healing was 61.7% in the ON101 group and 37.0% in the comparator (P =0.0001). In sub-group analysis according to risk factors, ON101 demonstrated superior healing capacity on Wagner grade 2 ulcers (P < 0.0001); plantar ulcers (P = 0.0016), ulcers size ≥5 cm² (P = 0.0122), ulcers duration ≥3 months (P = 0.0043); for patients with HbA1c ≥9% (P = 0.0285); and patients with BMI ≥25 (P = 0.0005). INNOVATION: ON101, a novel therapeutic drug, can modulate the functions of macrophages and demonstrate superior healing rates to conventional absorbent dressing in patients with hard-to-heal DFUs. CONCLUSIONS: The results of this post hoc study suggest that ON101 is a better therapeutic option than conventional dressing used in treatment for DFU patients with higher HbA1c, BMI, or ulcers with complex conditions such as longer duration, deeper wounds, larger size, and plantar location.

Three-Dimensional Photography for Evaluating the Effectiveness of Botulinum Toxin Injection for Masseter Hypertrophy.

BACKGROUND: Masseter hypertrophy is a common condition that causes a undesirable square face, and often treated with botulinum toxin type A (BoNTA). Subjective assessments of BoNTA effectiveness vary from physician to patient, necessitating an objective approach for evaluation. This study introduces three-dimensional photography (3DP) for the first time in clinical assessment to evaluate BoNTA treatment for masseter hypertrophy. METHODS: Ten patients received 36U of BoNTA at three injection points on each side masseter muscle. 3DP scanner using Artec Eva® was taken at the first, third, and sixth postoperative months for objective evaluation. Patient's self-perceived prominence, patients self-rated satisfaction, and physicians provided 5-grade scores were the subjective indicators. RESULTS: A significant decrease in left masseter volume at the sixth month (P = 0.002, P = 0.004 at rest and clenching, respectively) was observed. Patient's self-perceived prominence decreased at the first (P = 0.021) and third (P = 0.039) months. Physicians' scores significantly decreased at all postoperative months. No significant changes were noted in the right masseter volume and patients self-rated satisfaction. Patient self-rated satisfaction did not consistently correlate with objective measures, except for left masseter with clenching at the sixth month. CONCLUSION: Three-dimensional photography accurately quantifies facial changes post-BoNTA treatment. Despite objective improvements, patient satisfaction may not align consistently. Reliable assessment tools are crucial in cosmetic surgery to manage expectations and prevent disputes. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Full-Thickness Skin Graft from the Submental Triangle for Facial Defect Reconstruction.

Full-thickness skin grafting plays an important role in facial reconstruction for excessive skin defects or possible eye, nose, or lip distortion after a malignant tumor excision. For esthetic consideration, full-thickness skin grafts of the retroauricular region can be used, but the amount of skin is limited. The skin of the submental triangle has similar cutaneous features and provides a large graft. We aimed to evaluate the feasibility of using full-thickness skin grafts harvested from the submental triangle to reconstruct facial skin defects. We retrospectively analyzed 14 cases treated at a single institution to evaluate the clinical and esthetic outcomes, and patients' satisfaction. During 6-24 months of follow-up, the wounds healed with well-matched color, texture, and contour. No obvious hypertrophies or distortions were observed. Additionally, the removal of redundant submental triangle skin resulted in the secondary gain of double chin reduction. All patients were satisfied with the appearance of both donor and recipient sites. In conclusion, the submental triangle is a good possible option for full-thickness skin grafts used to resurface facial skin defects. Using this approach, both donor and recipient sites can achieve satisfactory esthetic outcomes.

Cost-effectiveness of Novel Macrophage-Regulating Treatment for Wound Healing in Patients With Diabetic Foot Ulcers From the Taiwan Health Care Sector Perspective.

Importance: Diabetic foot ulcers (DFUs) and subsequent amputation incur enormous health and economic burdens to patients, health care systems, and societies. As a novel macrophage-regulating drug, ON101 is a breakthrough treatment for DFUs, which demonstrated significant complete wound healing effects in a phase 3 randomized clinical trial, but its economic value remains unknown. Objective: To assess the cost-effectiveness of an ON101 cream added on to general wound care (GWC; ie, conventional treatments for DFUs, which comprised initial and regular foot examinations, ulcer management, comorbidity control, patient education, and multidisciplinary care) vs GWC alone for DFUs from the Taiwan health care sector perspective. Design, Setting, and Participants: This economic evaluation used a hypothetical cohort of patients with diabetes, with characteristics mirroring those of the participants in the ON101 trial. A Markov state-transition simulation model was constructed to estimate costs and health outcomes associated with the ON101 with GWC and GWC alone strategies over a 5-year time horizon, discounting costs and effectiveness at 3% annually. Costs were in 2021 US dollars. Data were sourced from the ON101 trial and supplemented from published literature. Deterministic and probabilistic sensitivity analyses were performed to assess the uncertainty of input parameters and study generalizability. The analysis was designed and conducted from September 1, 2020, to January 31, 2022. Exposures: ON101 with GWC vs GWC alone. Main Outcomes and Measures: DFU-related complications, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Results: Patients in the hypothetical cohort had a mean age of 57 years and an uninfected DFU of 1 to 25 cm2 that was present for 4 or more weeks with a Wagner grade of 1 or 2. Over 5 years, the ON101 with GWC group vs the GWC alone group experienced more healing events, stayed for a longer time in the healing state, and had fewer infected DFUs, gangrene, and amputations (eg, 2787 additional healing events and 2766 fewer infected DFU, 72 fewer amputation, and 7 fewer gangrene events in the ON101 with GWC group vs GWC alone group). The ON101 with GWC strategy vs GWC alone yielded an additional 0.038 QALYs at an incremental cost of $571, resulting in $14 922/QALY gained. Economic results were most sensitive to healing efficacy, drug cost, and health utility of the healing state. Cost-saving results were observed in patient subgroups with poor glycemic control, larger ulcer sizes, longer ulcer durations, and current smoking. The ON101 with GWC strategy was considered cost-effective in 60% to 82% of model iterations against willingness-to-pay thresholds of $32 787/QALY gained to $98 361/QALY gained. Conclusions and Relevance: In this economic evaluation study using a simulated patient cohort, the ON101 with GWC strategy represented good value compared with GWC alone for patients with DFUs from the Taiwan health care sector perspective and may be prioritized for those with high risks for disease progression of DFUs.

Validation of Fespixon in Postoperative Scar Cosmesis Using Quantitative Digital Photography Analysis.

BACKGROUND: Unsightly scarring after surgery remains a dilemma. One of the challenges is the lack of objective scar assessment tools. OBJECTIVES: This study aimed to evaluate the efficacy of a novel medicine, Fespixon, for prevention and/or alleviation of post-skin incision scarring. A second aim was to demonstrate the practicality of our digital image analysis system to see if this could serve as a sensitive tool to assess scar improvement. METHODS: A prospective, placebo-controlled trial involving patients with postoperative transverse scars was conducted. Each patient received a topical formulation of Fespixon on the left part of the scar and placebo cream on the right. In addition to recording the subjective modified Vancouver Scar Scale and visual analog scale scores, we utilized digital photography for monthly scar analysis, with CIELAB and hue serving as the colorimetric information, and with contrast, correlation, homogeneity, and entropy providing texture information. RESULTS: Forty-six participants (mean age, 52 years) were enrolled in the trial. All the parameters of subjective assessment showed superior results for the Fespixon-treated side, with significant differences in pigmentation, vascularity, pliability, height, itchiness, and patient satisfaction (P = .043, .013, .026, .002, .039, .012, respectively). The trends in color and texture showed increased relative difference ratios, with significant differences in most of the eigenvalues towards the Fespixon-treated side, including CIELAB-L* (P = .000), hue-R,G,B (red, blue, green) values (P = .034, .001, .011), contrast (P = .000), homogeneity (P = .000), correlation (P = .011), and entropy (P = .000). CONCLUSIONS: We validated the efficacy of Fespixon for postoperative scar healing based not only on subjective assessments but also on objective quantitative analyses. The results also indicated that our digital photography quantitative analysis system is an ideal tool for quantification of scar appearance.

A Very Rare Case of Necrotizing Fasciitis Caused by Metallosis.

Necrotizing fasciitis is a surgically diagnosed infection of the deep soft tissues that results in high mortality. It is usually caused by aerobic and anaerobic bacteria and group A Streptococcus. Metallosis is characterized by the deposition of metal debris in the blood that causes metal poisoning and tissue damage. The abrasion of metal components that occurs after joint replacements causes metallosis, which may lead to severe complications. We report a rare case of metallosis-induced necrotizing fasciitis of the right thigh. Metallosis should be considered as a cause of necrotizing fasciitis if the patient has had a joint replacement surgery.

Clinical Application of the Peroneal Artery Perforator Flap for Reconstruction of Lateral Malleolus Defects.

The reconstruction of defects of the lateral malleolus involving the exposed fibular bone or tendon is challenging. This study aimed to evaluate the clinical application of the peroneal artery perforator flap with or without split-thickness skin grafting for soft tissue reconstruction of the bony defect of the lateral malleolus of the ankle joints. Reconstruction using a peroneal artery perforator flap with or without split-thickness skin grafting was performed for 15 patients (10 men, 5 women) between January 2007 and December 2018. The mean age was 53.7 years, and the mean size of the flaps was 40 cm2. The flaps were elevated in the form of a perforator flap, and split-thickness skin grafting was performed over the flaps and adjoining raw areas. The flaps survived in all cases; however, partial necrosis was observed in 3 cases. In cases of small-sized defects of the lateral malleolus of the ankle joints where a flap is required for the exposed bone or tendon, reconstruction using the peroneal artery perforator flap is advantageous, since the morbidity rate of the donor site is low and soft tissue is reconstructed.

New Horizons of Macrophage Immunomodulation in the Healing of Diabetic Foot Ulcers.

Diabetic foot ulcers (DFUs) are one of the most costly and troublesome complications of diabetes mellitus. The wound chronicity of DFUs remains the main challenge in the current and future treatment of this condition. Persistent inflammation results in chronic wounds characterized by dysregulation of immune cells, such as M1 macrophages, and impairs the polarization of M2 macrophages and the subsequent healing process of DFUs. The interactive regulation of M1 and M2 macrophages during DFU healing is critical and seems manageable. This review details how cytokines and signalling pathways are co-ordinately regulated to control the functions of M1 and M2 macrophages in normal wound repair. DFUs are defective in the M1-to-M2 transition, which halts the whole wound-healing machinery. Many pre-clinical and clinical innovative approaches, including the application of topical insulin, CCL chemokines, micro RNAs, stem cells, stem-cell-derived exosomes, skin substitutes, antioxidants, and the most recent Phase III-approved ON101 topical cream, have been shown to modulate the activity of M1 and M2 macrophages in DFUs. ON101, the newest clinically approved product in this setting, is designed specifically to down-regulate M1 macrophages and further modulate the wound microenvironment to favour M2 emergence and expansion. Finally, the recent evolution of macrophage modulation therapies and techniques will improve the effectiveness of the treatment of diverse DFUs.

Restoring Prohealing/Remodeling-Associated M2a/c Macrophages Using ON101 Accelerates Diabetic Wound Healing.

Diabetic wounds exhibit chronic inflammation and delayed tissue proliferation or remodeling, mainly owing to prolonged proinflammatory (M1) macrophage activity and defects in transition to prohealing/proremodeling (M2a/M2c; CD206+ and/or CD163+) macrophages. We found that topical treatment with ON101, a plant-based potential therapeutic for diabetic foot ulcers, increased M2c-like (CD163+ and CD206+) cells and suppressed M1-like cells, altering the inflammatory gene profile in a diabetic mouse model compared with that in the controls. An in vitro macrophage-polarizing model revealed that ON101 directly suppressed CD80+ and CD86+ M1-macrophage polarization and M1-associated proinflammatory cytokines at both protein and transcriptional levels. Notably, conditioned medium collected from ON101-treated M1 macrophages reversed the M1-conditioned medium‒mediated suppression of CD206+ macrophages. Furthermore, conditioned medium from ON101-treated adipocyte progenitor cells significantly promoted CD206+ and CD163+ macrophages but strongly inhibited M1-like cells. ON101 treatment also stimulated the expression of GCSF and CXCL3 genes in human adipocyte progenitor cells. Interestingly, treatment with recombinant GCSF protein enhanced both CD206+ and CD163+ M2 markers, whereas CXCL3 treatment only stimulated CD163+ M2 macrophages. Depletion of cutaneous M2 macrophages inhibited ON101-induced diabetic wound healing. Thus, ON101 directly suppressed M1 macrophages and facilitated the GCSF- and CXCL3-mediated transition from M1 to M2 macrophages, lowering inflammation and leading to faster diabetic wound healing.

Modified Simultaneous Double Eyelid Blepharoplasty and Ptosis Correction With a Single-Knot, Continuous, Nonincisional Technique.

BACKGROUND: "Double eyelid" blepharoplasty is one of the most common cosmetic operations among Asian populations. Some patients might present with concomitant mild to moderate blepharoptosis, even though they choose initially to undergo blepharoplasty for cosmetic reasons. OBJECTIVE: Using nonincisional double eyelid surgery without ptosis correction tends to produce unsatisfactory results. We introduce our modified suture method for the simultaneous correction of blepharoptosis during double eyelid blepharoplasty. MATERIALS AND METHODS: We carried out a retrospective review on 13 patients who underwent simultaneous nonincisional ptosis correction and double eyelid surgery, using a single-knot continuous technique, from January 2017 to December 2019. A superior tarsal (Müller's) muscle tagging suture was utilized to achieve an accurate tucking during surgery and create a double upper lid fold simultaneously. RESULTS: The mean patient age was 31.8 years (range=23-54), and 9 patients (69%) were female. The mean marginal reflex distance 1 increased from 2.46±0.36 mm preoperatively to 4.07±0.61 mm postoperatively with a statistically significant difference. Most patients showed favorable results with an average of 10.8 months of follow-up and minimal complications. CONCLUSIONS: This simultaneous double eyelid blepharoplasty technique using a single-knot, continuous, nonincisional technique is relatively easy and effective, with minimal downtime and few postoperative complications, and avoids scarring for patients with mild to moderate blepharoptosis.

Simple and Efficient Pressure Ulcer Reconstruction via Primary Closure Combined with Closed-Incision Negative Pressure Wound Therapy (CiNPWT)-Experience of a Single Surgeon.

BACKGROUND: In this study, we aimed to analyze the clinical efficacy of closed-incision negative pressure wound therapy (CiNPWT) when combined with primary closure (PC) in a patient with pressure ulcers, based on one single surgeon's experience at our medical center. METHODS: We retrospectively reviewed the data of patients with stage III or IV pressure ulcers who underwent reconstruction surgery. Patient characteristics, including age, sex, cause and location of defect, comorbidities, lesion size, wound reconstruction methods, operation time, debridement times, application of CiNPWT to reconstructed wounds, duration of hospital stay, and wound complications were analyzed. RESULTS: Operation time (38.16 ± 14.02 vs. 84.73 ± 48.55 min) and duration of hospitalization (36.78 ± 26.92 vs. 56.70 ± 58.43 days) were shorter in the PC + CiNPWT group than in the traditional group. The frequency of debridement (2.13 ± 0.98 vs. 2.76 ± 2.20 times) was also lower in the PC + CiNPWT group than in the traditional group. The average reconstructed wound size did not significantly differ between the groups (63.47 ± 42.70 vs. 62.85 ± 49.94 cm2), and there were no significant differences in wound healing (81.25% vs. 75.38%), minor complications (18.75% vs. 21.54%), major complications (0% vs. 3.85%), or mortality (6.25% vs. 10.00%) between the groups. CONCLUSIONS: Our findings indicate that PC combined with CiNPWT represents an alternative reconstruction option for patients with pressure ulcers, especially in those for whom prolonged anesthesia is unsuitable.

Is 3-Dimensional Scanning Really Helpful in Implant-Based Breast Reconstruction?: A Prospective Study.

BACKGROUND: Breast reconstruction is an integral part of breast cancer treatment, and implant-based breast reconstruction is the most commonly used method worldwide. However, there is still no technique that allows surgeons to predict the volume of the required implant. Although computed tomography and magnetic resonance imaging provide adequate representations of the breast, these procedures are time-consuming, expensive, and expose patients to radiation. Therefore, there is a need for safer, noninvasive alternatives for preoperative breast volume measurements. PATIENTS AND METHODS: This study is a prospective review of 12 patients with early-stage breast cancer who underwent nipple-sparing mastectomy and immediate breast reconstruction with implants. Preoperatively, the Artec Eva 3D scanner was used to acquire volumetric measurements of the breasts. Intraoperatively, the volume of the mastectomy specimen was measured using the water displacement method. Correlations among the preoperative breast, mastectomy specimen, and estimated and final implant volumes were analyzed through Pearson correlation coefficient. A correction prediction factor of 85% was applied where necessary. Patient and physician satisfaction were evaluated 3 months postoperatively. RESULTS: Our study found a statistically significant correlation between the preoperative breast volumes measured by the Artec Eva 3D scanner and intraoperative mastectomy specimen volumes (r = 0.6578). There was no correlation between the preoperative breast volumes and final implant volumes, mastectomy specimen volumes and final implant volumes, and estimated implant volumes and final implant volumes. CONCLUSIONS: Although the Artec Eva 3D scanner can offer relatively accurate measurement of breast volumes, multiple studies still need to be done to determine how these data can be applied to the mastectomy procedure and breast implant selection. It may be more applicable for preoperative planning in breast augmentation surgery. Future surgeons should also take into account that variabilities in natural breast size, tumor size, cancer stage, and in patient and physician preferences all influence the outcome of breast reconstruction surgery.

Adipose-derived stem cell induced-tissue repair or wound healing is mediated by the concomitant upregulation of miR-21 and miR-29b expression and activation of the AKT signaling pathway.

BACKGROUND: Adipose-derived stem cells (ADSCs), a subpopulation of mesenchymal stem cells, are characterized by their potential to differentiate into multiple cell lineages. Due to their abundance and relative ease of procurement, ADSCs are widely used for tissue repair and regeneration. However, the molecular mechanisms of the therapeutic effect of ADSCs remain unknown. METHODS: MicroRNAs have emerged as important signaling molecules in skin wound healing, and their roles in ADSC-based therapies must be addressed. Here, we investigated the potential of ADSCs in improving cutaneous wound healing in vitro and in vivo. RESULTS: We simulated the microenvironment of the wound site by coculturing human dermal fibroblasts (HDFs) with ADSCs. We found that cocultured HDFs expressed significantly higher levels of miR-29b and miR-21 and had higher proliferation and migration rates than ADSCs cultured without HDFs. Moreover, increased expression of Collagen Type I Alpha 1 Chain (COL1A1), Collagen Type III Alpha 1 Chain (COL3A1), alpha-smooth muscle actin (α-SMA), vascular endothelial growth factor (VEGF), and Phosphoinositide 3-kinase (PI3K), p-Akt and decreased expression of Phosphatase and tensin homolog (PTEN) and matrix metalloproteinase (MMP)-1 was detected, suggesting extracellular remodeling and fibroblast activation and proliferation. We validated the in vitro results by using a rodent skin excisional wound model and implanted ADSC sheets in the wound. Compared with the controls, wounds implanted with ADSC sheets had significantly higher rates of wound-closure; increased expression of α-SMA, VEGF, PI3k, PTEN, COL1A1, and COL3A1; decreased expression of PTEN and MMP1; and upregulated levels of miR-29b and miR-21 in the skin. CONCLUSION: In summary, we evidenced that ADSCs facilitate the increase in miR-29b and miR-21 levels and promote the activation and proliferation of dermal fibroblasts and extracellular matrix (ECM) remodeling, with the associated release of VEGF. Thus, the ADSC-mediated increase in microRNAs is essential in tissue repair and has a therapeutic potential in cutaneous wound healing.

Negative-pressure wound therapy combined with artificial dermis (Terudermis) followed by split-thickness skin graft might be an effective treatment option for wounds exposing tendon and bone: A retrospective observation study.

ABSTRACT: Skin grafts are not suitable for closing tendon- or bone-exposing wounds, which require flap surgery. Dermal regeneration templates have value for closing such wounds, but the disadvantages of the technique include implantation failures because of infection, hematoma formation, or inappropriate immobilization. Negative-pressure wound therapy was reported to increase graft acceptance in difficult wounds.This retrospective case series of 65 patients evaluated negative-pressure therapy combined with artificial dermis for the treatment of acute or chronic tendon- or bone-exposing wounds. The artificial dermis was placed after adequate wound-bed preparation, with simultaneous application of a vacuum-assisted closure system. Split-thickness skin grafting was performed after the implanted artificial dermis had become established.The overall success rate was 88.1% (59/67): 88.6% (39/44) in the chronic wounds group and 87% (20/23) in the acute-trauma group separately. The overall mean survival time of artificial dermis in success cases was 13.24 ±â€Š7.14 days. In separately, the survival time of artificial dermis had no statistically difference in chronic wound group (13.64 ±â€Š7.53 vs 12.60 ±â€Š5.86. P = .943), but had significant statistical difference in acute trauma group (12.45 ±â€Š6.44 days vs 23.33 ±â€Š4.04 days, P = .018). Also, comorbidity of PAOD was found a strong risk factor of failure in chronic wound group (100% vs 23.1%, P < 0.001).We concluded that artificial dermis combined with negative-pressure therapy followed by split-thickness skin grafting might be a reliable and effective option for surgical reconstruction of tendon- or bone-exposing wounds, and could decreasing waiting periods of autologous skin graft.

Necrotizing Fasciitis Caused by Aeromonas hydrophila With Catastrophic Progression.

Necrotizing fasciitis is a severe deep soft tissue infection with poor disease prognosis. The Aeromonas species is characterized as gram-negative, facultative, anaerobic small bacilli that are ubiquitously distributed in aquatic environments. Necrotizing fasciitis caused by this species is rare but has an extremely high mortality rate, especially in immunocompromised individuals. This study presents the case of a 39-year-old man with alcoholic liver cirrhosis, Child-Pugh class B, with necrotizing fasciitis caused by Aeromonas hydrophila. Despite debridement and bilateral above-knee amputation performed immediately, rapid progression to bilateral upper limbs and trunk was noted in 24 hours. The patient expired from septic shock with multiple organ failure in less than 48 hours following initial presentation. Two similar cases with different medical intervention and results have been reported in the literature and are further discussed in the present study. This allows the authors to suggest potential solutions for an improved clinical outcome.

Is sequential free flap safe in oral cancer reconstruction in the same patient? An outcome and complication analysis.

BACKGROUND: Sequential free flap reconstruction in patient with head and neck cancer can provide reliable and effective wound coverage. Only a few studies have reported on the outcome and complications analysis but without consensus on the recipient vessels and flap chosen. Herein, we presented the outcome and analysed the risk factors for complications in sequential free flap reconstruction. PATIENTS AND METHODS: Patients who had sequential free tissue transfers due to cancer recurrence, second primary cancer, or secondary correction of the soft tissue contractures and volume deficits were all included. Variables extracted included demographics, comorbidities, free flap characteristics, infection, dehiscence and flap necrosis rates. RESULTS: In total, 40 patients with 92 free flaps were analyzed; 42 initial and 50 sequential free flaps. The most common recipient vessels for sequential flap were contralateral superficial thyroid vessels (68%). The most common flap for both initial and sequential free flap was anterolateral thigh flap (64.3 and 62%). The success rate of sequential free flap was 92.0 compared to 92.9% for initial free flap, which showed no significant difference. Female was independently associated with delayed wound healing with an odds ratio of 90.91 (95% confidence interval 0.001-0.17, P = 0.001), as well as diabetes with an odds ratio of 31.14 (95% confidence interval 2.60-373.19, P = 0.007). Sequential free flap was not a risk factor for any complication. CONCLUSIONS: Sequential free flap is a reliable method for head and neck surgery without more complication rate comparing to initial free flap reconstruction. More attentions should be paid on patients with preferential risk for certain complications.

Scalp melanoma with rectus abdominis metastasis: A rare case report.

RATIONALE: The main cause of death in melanoma patients is widespread metastases as it can metastasize to almost every organ. However, melanoma skeletal muscle metastases (MSMM) are exceptional, and only a few cases of MSMM to the rectus abdominis muscles have been previously described. And our case maybe the first reported case in Asia region. PATIENT CONCERNS: A 45-year-old man with history of right scalp melanoma, pT3aN0M0, stage IIA status post wide excision with 2 cm safe margin and right neck lymph node dissection at 5 years before. He had an almost 5 years disease-free period but presented to our clinic due to intermittent abdominal sharp pain for 1 to 2 months, with a palpable soft tissue mass over his right abdomen. Metastatic melanoma to rectus abdominis muscles was highly suspected. INTERVENTIONS: The patient subsequently underwent radical en-block extraperitoneal 15 cm segmental resection of the right rectus abdominis muscle including tumor mass. The resected tumor was a black-gray colored solid mass, and the final histologic study showed a metastasis of melanoma. OUTCOMES: Postoperative course of the patient was uneventful, and the right abdominal pain was improved. The patient was referred for further target therapy, but passed away half a year later due to multiple metastasis. LESSONS: Scalp melanoma with isolated rectus muscle metastasis is extremely rare especially for a young aged patient who had an almost 5-year disease-free period. Surgery is a potentially curative therapy for patients with isolated metastatic melanoma. The goal is negative resection margins, in order to avoid local recurrences. Radical compartmental surgery should be considered for selected stage IV melanoma patients with sole rectus abdominis MSMM, whose disease could be amenable to complete resection, in preliminary procedure to prolong disease-free survival time. For oligometastatic disease, surgical resection is sometimes useful in carefully selected patients after systemic therapy; also, it could be performed as symptomatic treatment.