BACKGROUND AND OBJECTIVES

Mouth retractors are essential in ensuring efficient yet safe exposure of the oral cavity and oropharynx. However, when applied improperly or haphazardly, retractors can cause tissue injuries and compromise patient safety. In addition, there are gaps in the usability of existing designs. This study aimed to identify the issues encountered by otorhinolaryngology surgeons in the use of commercially available mouth retractors, design and fabricate an improved retractor, and explore the use of additive manufacturing (popularly known as 3D printing) for retractor prototyping.

The study used the United States Food and Drug Administration (US FDA) Design Control as its framework. End-user requirements from otorhinolaryngologists were collected through key informant interviews. Results were organized into a Design Input template which was used to guide the design and development process. Prototype designs were iteratively created using computer-aided design software and 3D printing. Once design specifications were satisfied, a beta prototype was fabricated and given to another cohort of otorhinolaryngologists. The participants assessed the usability of the beta prototype. System Usability Scale (SUS) was used to quantify participant's feedback.

Five designs were created in the course of the study. The final prototype was fabricated using a Stereolithography (SLA) 3D printer. Several features were developed to address user requirements. The primary modification was to make the retractor modular to facilitate easier and shorter mounting and assembly. Gingival injury was addressed with the replacement of the maxillary alveolus hook with support bars. Five participants evaluated the beta prototype which received a mean SUS score of 75, well above the 50th percentile threshold.

This study demonstrates the applicability of the US FDA Design Control Process in the local setting to improve the mouth retractor design. Clinical and ergonomic issues were identified and design solutions were proposed and some have been implemented in a low-fidelity prototype. Results of the small-scale usability test suggest that the present form factor can be the basis for further iterations. Future studies can implement the proposed features to address other clinical and ergonomic needs.

OBJECTIVE: To investigate the clinical application of high-frequency color Doppler ultrasound (HFCDU) in detecting perforators in the deep adipose layers for harvesting super-thin anterolateral thigh flap (ALTF). METHODS: Between August 2019 and January 2023, 45 patients (46 sides) with skin and soft tissue defects in the foot and ankle were treated, including 29 males and 16 females, aged from 22 to 62 years, with an average of 46.7 years. The body mass index ranged from 19.6 to 36.2 kg/m ², with an average of 23.62 kg/m ². The causes of injury included traffic accident injury in 15 cases, heavy object crush injury in 20 cases, mechanical injury in 8 cases, heat crush injury in 1 case, and chronic infection in 1 case. There were 20 cases on the left side, 24 cases on the right side, and 1 case on both sides. After thorough debridement, the wound size ranged from 5 cm×4 cm to 17 cm×11 cm. All patients underwent free super-thin ALTF transplantation repair. HFCDU was used to detect the location of the perforators piercing the deep and superficial fascia, as well as the direction and branches of the perforators within the deep adipose layers before operation. According to the preoperative HFCDU findings, the dimensions of the super-thin ALTF ranged from 6 cm×4 cm to 18 cm×12 cm. The donor sites of the flaps were directly sutured. RESULTS: A total of 55 perforators were detected by HFCDU before operation, but 1 was not found during operation. During operation, a total of 56 perforators were found, and 2 perforators were not detected by HFCDU. The positive predictive value of HFCDU for identifying perforator vessels was 98.2%, and the sensitivity was 96.4%. Among the 54 perforators accurately located by HFCDU, the orientation of the perforators in the deep adipose layers was confirmed during operation. There were 21 perforators (38.9%) traveled laterally and inferiorly, 12 (22.2%) traveled medially and inferiorly, 14 (25.9%) traveled laterally and superiorly, 5 (9.3%) traveled medially and superiorly, and 2 (3.7%) ran almost vertically to the body surface. Among the 54 perforators accurately located by HFCDU, 35 were identified as type 1 perforators and 12 as type 2 perforators (HFCDU misidentified 7 type 2 perforators as type 1 perforators). The sensitivity of HFCDU in identifying type 1 perforators was 100%, with a positive predictive value of 83.3%. For type 2 perforators, the sensitivity was 63.2%, and the positive predictive value was 100%. The surgeries were successfully completed. The super-thin ALTF had a thickness ranging from 2 to 6 mm, with an average of 3.56 mm. All super-thin ALTF survived, however, 1 flap experienced a venous crisis at 1 day after operation, but it survived after emergency exploration and re-anastomosis of the veins; 1 flap developed venous crisis at 3 days after operation but survived after bleeding with several small incisions; 3 flaps had necrosis at the distal edge of the epidermis, which healed after undergoing dressing changes. All 45 patients were followed up 6-18 months (mean, 13.6 months). Three flaps required secondary defatting procedures, while the rest had the appropriate thickness, and the overall appearance was satisfactory. CONCLUSION Preoperative application of HFCDU to detect the perforator in the deep adipose layers can improve the success and safety of the procedure by facilitating the harvest of super-thin ALTF.
Male ; Female ; Humans ; Thigh/surgery* ; Plastic Surgery Procedures ; Prospective Studies ; Skin Transplantation ; Free Tissue Flaps ; Burns ; Soft Tissue Injuries/surgery* ; Ultrasonography, Doppler, Color ; Crush Injuries/surgery* ; Perforator Flap ; Treatment Outcome

OBJECTIVE: To explore the feasibility and effectiveness of a foldable pedicled latissimus dorsi myocutaneous flap to repair soft tissue defects in the shoulder and back. METHODS: Between August 2018 and January 2023, the foldable pedicled latissimus dorsi myocutaneous flaps were used to repair soft tissue defects in the shoulder and back of 8 patients. There were 5 males and 3 females with the age ranged from 21 to 56 years (mean, 35.4 years). Wounds were located in the shoulder in 2 cases and in the shoulder and back in 6 cases. The causes of injury were chronic infection of skin and bone exposure in 2 cases, secondary wound after extensive resection of skin and soft tissue tumor in 4 cases, and wound formation caused by traffic accident in 2 cases. Skin defect areas ranged from 14 cm×13 cm to 20 cm×16 cm. The disease duration ranged from 12 days to 1 year (median, 6.6 months). A pedicled latissimus dorsi myocutaneous flap was designed and harvested. The flap was divided into A/B flap and then were folded to repair the wound, with the donor area of the flap being pulled and sutured in one stage. RESULTS: All 7 flaps survived, with primary wound healing. One patient suffered from distal flap necrosis and delayed healing was achieved after dressing change. The incisions of all donor sites healed by first intention. All patients were followed up 6 months to 4 years (mean, 24.7 months). The skin flap has a good appearance with no swelling in the pedicle. At last follow-up, 6 patients had no significant difference in bilateral shoulder joint motion, and 2 patients had a slight decrease in abduction range of motion compared with the healthy side. The patients' daily life were not affected, and linear scar was left in the donor site. CONCLUSION The foldable pedicled latissimus dorsi myocutaneous flap is an ideal method to repair the soft tissue defect of shoulder and back with simple operation, less damage to the donor site, and quick recovery after operation.
Male ; Female ; Humans ; Young Adult ; Adult ; Middle Aged ; Plastic Surgery Procedures ; Myocutaneous Flap/surgery* ; Shoulder/surgery* ; Skin Transplantation ; Superficial Back Muscles/transplantation* ; Soft Tissue Injuries/surgery* ; Wound Healing ; Treatment Outcome ; Perforator Flap

This is a case of a 20-year-old female with no known comorbidities presenting with verrucous plaques arranged in a unilateral blaschkoid distribution at birth. Biopsy was consistent with epidermal nevus hence patient was diagnosed as systematized epidermal nevus, Nevus Unius Lateris type. Gold standard treatment is full thickness surgical excision however, due to the extensive involvement, treatment of this condition remains a challenge. Hence, non-surgical combination of ablative CO2 laser and topical tretinoin 0.1% were done. Thinner lesions (1-3 mm) showed lower recurrence (50%) as compared to thicker lesions (>3 mm) showing 100% recurrence after six months. Hence, another CO2 laser session is needed. Quality of life was measured using the Dermatologic Life Quality Index (DLQI) with noted 35% improvement post-treatment.
CO2 laser ; lasers, gas ; tretinoin ; retinoids

BACKGROUND: Synovectomy has been introduced into total knee arthroplasty (TKA) with the aim of relieving pain and inflammation of the synovium. However, there are no long-term, comparative data to evaluate the effect of synovectomy in TKA. This study was aimed at assessing pain, function, and complications in patients undergoing synovectomy during TKA for osteoarthritis (OA) at long-term follow-up. METHODS: This was a prospective randomized controlled trial of 42 consecutive patients who underwent staged bilateral TKA. Patients undergoing the first-side TKA were allocated to receive TKA with or without synovectomy followed by a 3-month washout period and crossover to the other strategy for the opposite-side TKA. The overall efficacy of both strategies was evaluated by determination of blood loss, the Knee Society score (KSS), and knee inflammation conditions during a 3-month postoperative period. The postoperative pain, range of motion (ROM), and complications were sequentially evaluated to compare the two groups until 10 years after surgery. RESULTS: At the 10-year follow-up, both groups had a similarly significantly improved ROM (114.88 ± 9.84° vs. 114.02 ± 9.43°, t  = 0.221, P  = 0.815) and pain relief with no differences between the two groups (1.0 [1.0] vs. 1.0 [1.5], U  = 789.500, P  = 0.613). Similar changes in total blood loss, KSS, and knee inflammation were found in both groups during 3 months postoperatively ( P  > 0.05). Additionally, there was no significant difference regarding complications and satisfaction between the two groups ( P  > 0.05). CONCLUSIONS: Synovectomy in conjunction with TKA for primary OA does not seem to provide any benefit regarding postoperative pain, ROM, and satisfaction during a 10-year follow-up. In addition, it may not result in more blood loss and increased incidence of long-term complications. Based on our long-term findings, it should not be performed routinely. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR-INR-16008245; https://www.chictr.org.cn/showproj.aspx?proj=13334 .
Humans ; Arthroplasty, Replacement, Knee/methods* ; Synovectomy/methods* ; Osteoarthritis, Knee/surgery* ; Prospective Studies ; Pain, Postoperative ; Inflammation/etiology* ; Range of Motion, Articular ; Knee Joint/surgery* ; Treatment Outcome ; Knee Prosthesis/adverse effects*

Humans ; Child ; Achilles Tendon/surgery* ; Surgical Flaps ; Plastic Surgery Procedures ; Rupture

OBJECTIVE: To investigate the clinical efficacy of unicompartmental knee arthroplasty (UKA) in the treatment of knee osteoarthritis in patients over 75 years old. METHODS: The clinical efficacy of primary fixed platform UKA in patients with osteoarthritis, was retrospectively analyzed from October 2014 to November 2020. Age, body mass index (BMI), range of motion (ROM), preoperative joint function score, the quality of life score and other preoperative indicators were measured by propensity score matching (PSM). The patients were divided into elderly group (≥75 years old) and control group (<75 years old). Oxford knee score(OKS), Western Ontario McMaster Universities osteoarthritis index(WOMAC), Short Form-12 including physical component summary (PCS), mental component summary(MCS), minimal clinically important difference(MCID ) and clinical complications were evaluated preoperatively and postoperatively. RESULTS: A total of 514 patients were analyzed, 428 patients fulfilled the inclusion criteria. A propensity-score matching study was conducted to eliminate confounding factors. After 1∶2 propensity match, there were 84 patients in elderly group (≥75 years), age ranged from 75 to 88 years old, with an average of (78.79±3.08) years old, and 168 patients in control group (<75 years), age ranged from 47 to 74 years old, with an average of (64.10±5.96)years old. The follow-up duration of two groups ranged from 12 to 84 months with an average of (29.35±16.52) months in elderly group, and 12 to 85 months with an average of (31.83±17.34) months in control group. There was only significant difference in age between the elderly and control groups preoperatively (P<0.01). Postoperatively, the elderly group showed significantly higher WOMAC (P<0.01) and lower SF-12 PCS scores (P<0.01) as compared to the control group. There was no significant difference between the elderly group and the control group in knee range of motion, OKS and the proportion of each scoring system reaching the minimum clinical difference value (P>0.05). In the aspect of preperative complications, the elderly group exhibited more surgical site complications and postoperative delirium compared to control group(P<0.05). The differences in other indicators including deep vein thrombosis, acute urinary retention, cardiovascular events, cerebrovascular events and radiolucent lines around prothesis were not statistically significant(P>0.05). CONCLUSION UKA in the treatment of elderly patients over 75 years old with knee osteoarthritis was safe and feasible, and could obtain satisfactory short-term efficacy.
Humans ; Aged ; Aged, 80 and over ; Middle Aged ; Osteoarthritis, Knee/surgery* ; Knee Prosthesis ; Retrospective Studies ; Propensity Score ; Quality of Life ; Knee Joint/surgery* ; Arthroplasty, Replacement, Knee/methods* ; Treatment Outcome

Post-burn contractures are common entities seen in developing countries. There are multiple reasons for the development of contractures, most are preventable. In extensive contractures, a strategic plan is necessary to release all contractures and yet not antagonize post-operative positions. It is also necessary to be cost-effective and minimize the number of surgeries needed. Conventionally the release sequence in extensive burn contractures is proximal to distal. In this case report, we discuss an unusual sequence where we released distal contractures before the proximal to achieve optimum results. A 3-year-old child with post-burn contracture of hand, wrist, elbow, and axilla was treated in 2 stages, with the release of wrist contracture and cover with pedicled abdominal flap in the first stage and division of pedicled flap with the release of axilla and elbow contracture in the second stage. Thus, the release of all contractures was achieved without antagonizing post-operative positions and minimized the number of surgeries. A case-based approach may be crucial in making a strategic surgical plan to minimize the rehabilitation phase, rather than following known dictums.
Humans ; Child, Preschool ; Surgical Flaps/surgery* ; Upper Extremity ; Plastic Surgery Procedures ; Skin Transplantation ; Contracture/surgery*

Objective: To explore the clinical effects of fractional carbon dioxide laser combined with minimally invasive scar release in the treatment of post-acne atrophic scars. Methods: A retrospectively observational study was conducted. From January to June 2021, 60 patients with grade 3 and 4 post-acne atrophic scars who met the inclusion criteria were admitted to the First Affiliated Hospital of Henan University of Traditional Chinese Medicine. According to the adopted treatment methods, 30 patients treated with fractional carbon dioxide laser combined with minimally invasive scar release were included in combined treatment group (19 males and 11 females, aged (26±4) years), and 30 patients treated with fractional carbon dioxide laser alone were included in laser alone group (18 males and 12 females, aged (25±6) years). All the patients received the treatment once every two months, totally 3 times. Before the first treatment and 2 months after the last treatment, the scars were assessed by échelle d'évaluation clinique des cicatrices d'acné (ECCA). In 2 months after the last treatment, the curative effect was evaluated and the total effective rate was calculated according to the ECCA score. The adverse reactions of patients during the treatment were recorded. Data were statistically analyzed with independent sample t test, Wilcoxon rank-sum test, Mann-Whitney U test, chi-square test, and Fisher's exact probability test. Results: Before the first treatment, the ECCA scores of patients in the two groups were similar (P>0.05). In 2 months after the last treatment, the ECCA scores of patients in combined treatment group were significantly lower than those of laser alone group (Z=-2.89, P<0.05). The ECCA scores of patients in combined treatment group and laser alone group in 2 months after the last treatment were both significantly lower than those before the first treatment (with Z values of -4.81 and -4.79, respectively, P<0.05). In 2 months after the last treatment, the treatment in laser alone group cured the scars in 2 patients, and were markedly effective in 13 patients, effective in 7 patients, and ineffective in 8 patients; the treatment in combined treatment group cured the scars in 4 patients, and were markedly effective in 22 patients, effective in 3 patients, and ineffective in one patients. The total effective rate of scar treatment in combined treatment group (96.67%, 29/30) was significantly higher than 73.33% (22/30) in laser alone group (P<0.05). During treatment, in combined treatment group, 3 patients had pain, one patient had redness and swelling, and one patient had pigmentation. In laser alone group, one patient had pain, and 2 patients had pigmentation. No infection occurred in the wounds of all the patients in the two groups. Conclusions: Compared with fractional carbon dioxide laser alone, fractional carbon dioxide laser combined with minimally invasive scar release for post-acne atrophic scars can result in a higher total effective rate, with simple operation and good effect, so it is worthy of clinical application.
Male ; Female ; Humans ; Cicatrix/therapy* ; Retrospective Studies ; Treatment Outcome ; Lasers, Gas/therapeutic use* ; Acne Vulgaris ; Atrophy ; Pain ; Carbon Dioxide

Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.
Device Approval ; China ; Equipment and Supplies