With the encouragement of policies and the rapid development of the biopharmaceutical industry,the number of software as medical device(SaMD)registration applications in Shanghai has continued to increase in recent years,and this paper summarizes the GMP nonconformities found in the field inspection of SaMD in Shanghai from 2020 to 2023,and the results show that nearly 70%of the problems were found in the software development process.Through in-depth analysis,this paper proposes the corresponding countermeasures for the problems found in the five most common stages such as software requirements,software design,software testing,software defect management and software configuration management,combined with the characteristics of software development.These suggested measures have certain reference significance for medical device software development and quality control personnel,and technical reviewer and inspectors.

Objective:To explore the distribution characteristics of the perforators of the oblique branch of the lateral circumflex femoral artery, and to report the clinical effect of the anterolateral thigh flap pedicled with the oblique branch in repairing the wounds of the extremities.Methods:The clinical data of the patients with anterolateral thigh flap pedicled with oblique branch of lateral circumflex femoral artery in Suzhou Ruihua Orthopaedic Hospital from December 2020 to April 2021 were analyzed retrospectively. High frequency color Doppler ultrasound was used to detect the large perforators of the oblique branch of the lateral circumflex femoral artery near the midpoint of the line between the anterior superior iliac spine and the lateral margin of the patella. With reference to the location of the perforators, according to the size and shape of the defect in the recipient area, the anterolateral thigh flap pedicled with oblique branch was designed and dissected to repair the wound. During the operation, the distance between the emitting point of the main oblique branch, the skin entry point of the perforators and the anterior superior iliac spine was measured with a steel ruler, the diameter of the perforators was measured with a microscale, and the number of perforators was counted. The survival and complications of the flap were observed and followed up after operation. In the last follow-up, the comprehensive evaluation scale was used to evaluate the repair effect: 90 to 100 points is excellent, 75 to 89 points is good, 60 to 74 points is average, and less than 60 points is poor.Results:A total of 84 patients were included, including 62 males and 22 females, aged from 14 to 82 years (mean 46.9 years), including 32 cases of hand wounds, 6 cases of forearm wounds, 3 cases of upper arm wounds, 10 cases of calves and 33 cases of foot and ankle wounds. The wound area was 6 cm × 4 cm-20 cm × 45 cm. A total of 88 flaps were removed in 84 patients (skin flaps on both thighs were removed in 4 patients). The size of the skin flap of 88 thighs was 7 cm × 5 cm-37 cm × 11 cm, of which 85 sides of 82 cases survived completely. One case of diabetes had complete necrosis 1 month after operation, and 1 case of 34 cm had necrosis of the distal end of 3 cm × 3 cm skin flap. Necrotic skin flaps were repaired with skin grafting. Four patients developed arterial crisis within 24 hours after operation, and those flaps survived after surgical exploration. All donor areas healed. During the follow-up of 6 to 9 months, the shape of the recipient area was normal in all patients, and there was no deep tissue infection such as osteomyelitis. The color and texture of all flaps were good. The sensation returned to S1-S2 after operation. The skin flap comprehensive evaluation scale was used to evaluate the repair effect. The patients’ score ranged from 73 to 94 points, with an average of 88.1 points. Including 33 excellent cases, 46 good cases and 5 average cases, the excellent and good rate was 94.0%(79/84). A total of 215 perforators were marked with 88 flaps before operation, and 208 perforators were found during the operation(the diameter of the perforators was 0.4-1.5 mm), of which 130 were sent out by oblique branches. There were perforators of the oblique branch in all flaps, with an average of 1.5 on each side, including 84(64.6%) septocutaneous perforators and 46(35.4%) musculocutaneous perforators. Most of the oblique branches originate from the lateral circumflex femoral artery, which runs in the intermuscular septum between the rectus femoris and the intermediate femoris muscle. It is divided into deep branches and superficial branches at the middle and upper 1/3 junction of the line between the anterior superior iliac spine and the lateral margin of the patella. The skin perforators of the oblique branch of the lateral circumflex femoral artery is mostly sent out from the superficial branch, and there are 118 perforators located at the midpoint and proximal end of the line between the anterior superior iliac spine and the lateral margin of the patella, accounting for 90.8% (118/130), reaching a peak at 0.4 (there are 37 perforators).Conclusion:The oblique branch of the lateral circumflex femoral artery is relatively constant, and most of the perforators are located near the midpoint of the line between the anterior superior iliac spine and the lateral margin of the patella, and the proportion of septocutaneous perforator is high. The distribution of perforator is regular, the blood supply is reliable, the application mode is flexible, and the donor site position is more concealed while the blood supply of the flap is secured.

Objective:To explore the distribution characteristics of the perforators of the oblique branch of the lateral circumflex femoral artery, and to report the clinical effect of the anterolateral thigh flap pedicled with the oblique branch in repairing the wounds of the extremities.Methods:The clinical data of the patients with anterolateral thigh flap pedicled with oblique branch of lateral circumflex femoral artery in Suzhou Ruihua Orthopaedic Hospital from December 2020 to April 2021 were analyzed retrospectively. High frequency color Doppler ultrasound was used to detect the large perforators of the oblique branch of the lateral circumflex femoral artery near the midpoint of the line between the anterior superior iliac spine and the lateral margin of the patella. With reference to the location of the perforators, according to the size and shape of the defect in the recipient area, the anterolateral thigh flap pedicled with oblique branch was designed and dissected to repair the wound. During the operation, the distance between the emitting point of the main oblique branch, the skin entry point of the perforators and the anterior superior iliac spine was measured with a steel ruler, the diameter of the perforators was measured with a microscale, and the number of perforators was counted. The survival and complications of the flap were observed and followed up after operation. In the last follow-up, the comprehensive evaluation scale was used to evaluate the repair effect: 90 to 100 points is excellent, 75 to 89 points is good, 60 to 74 points is average, and less than 60 points is poor.Results:A total of 84 patients were included, including 62 males and 22 females, aged from 14 to 82 years (mean 46.9 years), including 32 cases of hand wounds, 6 cases of forearm wounds, 3 cases of upper arm wounds, 10 cases of calves and 33 cases of foot and ankle wounds. The wound area was 6 cm × 4 cm-20 cm × 45 cm. A total of 88 flaps were removed in 84 patients (skin flaps on both thighs were removed in 4 patients). The size of the skin flap of 88 thighs was 7 cm × 5 cm-37 cm × 11 cm, of which 85 sides of 82 cases survived completely. One case of diabetes had complete necrosis 1 month after operation, and 1 case of 34 cm had necrosis of the distal end of 3 cm × 3 cm skin flap. Necrotic skin flaps were repaired with skin grafting. Four patients developed arterial crisis within 24 hours after operation, and those flaps survived after surgical exploration. All donor areas healed. During the follow-up of 6 to 9 months, the shape of the recipient area was normal in all patients, and there was no deep tissue infection such as osteomyelitis. The color and texture of all flaps were good. The sensation returned to S1-S2 after operation. The skin flap comprehensive evaluation scale was used to evaluate the repair effect. The patients’ score ranged from 73 to 94 points, with an average of 88.1 points. Including 33 excellent cases, 46 good cases and 5 average cases, the excellent and good rate was 94.0%(79/84). A total of 215 perforators were marked with 88 flaps before operation, and 208 perforators were found during the operation(the diameter of the perforators was 0.4-1.5 mm), of which 130 were sent out by oblique branches. There were perforators of the oblique branch in all flaps, with an average of 1.5 on each side, including 84(64.6%) septocutaneous perforators and 46(35.4%) musculocutaneous perforators. Most of the oblique branches originate from the lateral circumflex femoral artery, which runs in the intermuscular septum between the rectus femoris and the intermediate femoris muscle. It is divided into deep branches and superficial branches at the middle and upper 1/3 junction of the line between the anterior superior iliac spine and the lateral margin of the patella. The skin perforators of the oblique branch of the lateral circumflex femoral artery is mostly sent out from the superficial branch, and there are 118 perforators located at the midpoint and proximal end of the line between the anterior superior iliac spine and the lateral margin of the patella, accounting for 90.8% (118/130), reaching a peak at 0.4 (there are 37 perforators).Conclusion:The oblique branch of the lateral circumflex femoral artery is relatively constant, and most of the perforators are located near the midpoint of the line between the anterior superior iliac spine and the lateral margin of the patella, and the proportion of septocutaneous perforator is high. The distribution of perforator is regular, the blood supply is reliable, the application mode is flexible, and the donor site position is more concealed while the blood supply of the flap is secured.

Objective:To investigate the curative effects of the superficial peroneal artery perforator flap carrying two and more homologous perforators in repairing hand and foot wounds.Methods:A retrospective observational study was conducted. From January to September 2021, 23 patients with hand and foot wounds combined with bone or tendon exposure who met the inclusion criteria were admitted to Suzhou Ruihua Orthopaedic Hospital, including 16 males and 7 females, aged 23 to 68 years. After expansion of the wound, the wound area was 3.0 cm×2.0 cm to 11.0 cm×4.0 cm. All the wounds were repaired with the superficial peroneal artery perforator flap carrying two and more homologous perforators. The area of the resected flap was 4.0 cm×2.0 cm to 12.0 cm×5.0 cm. All the wounds in donor areas were sutured directly. During the operation, the resection of the flap, the number and caliber of carried perforators, the caliber of superficial peroneal artery, the length of vascular pedicle, and the number of accompanying veins of the superficial peroneal artery were recorded. The survival of the flap, the occurrence of complications, and the wound healing in the donor area were observed after operation. The recovery of the donor and recipient areas was followed up. At the last follow-up, the comprehensive evaluation scale was used to evaluate the curative effect of flap repair, and the sensory grading scale was used to evaluate the sensory function of the recipient area.Results:Totally 24 flaps were successfully resected in surgical operations, carrying 56 superficial peroneal artery perforators in total, with the caliber of perforators of 0.20-0.70 mm. The calibers of all perforators carried by 7 flaps were smaller than 0.40 mm. Nineteen flaps carried 2 perforators each, 3 flaps carried 3 perforators each, 1 flap carried 4 perforators, and 1 flap carried 5 perforators. During the operation, the superficial peroneal artery was resected with a caliber of 0.40-1.50 mm, the vascular pedicle was 2-6 cm in length, and each superficial peroneal artery had two accompanying veins. After operation, all the flaps survived smoothly, no vascular crisis or distal necrosis occurred, and the wounds healed well in the donor area. During the follow-up of 6 to 10 months after operation, the color, texture, and elasticity of the recipient area were good. Among them, 6 recipient areas were thinned and reshaped because of bloating. There was only linear scar and no obvious scar hyperplasia or pigmentation in the donor area, without significant change in sensory or motor function. At the last follow-up, the curative effect evaluation of flap repair was excellent in 22 flaps and good in 2 flaps, and the sensory function evaluation of the recipient area was grade S 3 in 1 area and grade S 2 in 23 areas. Conclusions:The superficial peroneal artery perforator flap with two and more homologous perforators has sufficient and reliable blood supply and is effective in repairing hand and foot wounds. It provides an ideal solution for the clinical problem in which the original operation scheme is abandoned due to the existence of only multiple slender perforators of caliber smaller than 0.40 mm, and only a single perforator in the operative field that cannot satisfy the needs of the flap blood supply and recipient area.

Objective:To investigate the therapeutic efficacy of bilobated superficial peroneal artery perforator flap in repairing two adjacent wounds of the fingers.Methods:A retrospective observational study was conducted. From January 2021 to January 2022, 15 patients with two adjacent wounds of the fingers who met the inclusion criteria were hospitalized in Suzhou Ruihua Orthopaedic Hospital, including 10 males and 5 females, aged 25 to 51 years. The area of single wound after debridement was from 2.5 cm×2.0 cm to 7.5 cm×2.5 cm. All the wounds were repaired by the bilobated superficial peroneal artery perforator flap from the lower leg. The single lobe area of bilobated flap was from 3.0 cm×2.0 cm to 8.0 cm×3.0 cm. The wounds in all the donor sites were sutured directly. During the operation, the number of resected flaps, the number and type of carried perforators were recorded, and the calibers of perforator and superficial peroneal artery and the length of vascular pedicle were measured. The survival of flap and the wound healing in the donor and recipient sites were recorded after operation. The recovery of donor and recipient sites were recorded during follow-up. At the last follow-up, the repair effect of flap was evaluated by the comprehensive evaluation scale, and the sensory function of flap was evaluated by the sensory function evaluation standard of British Medical Research Association.Results:During the operation, 15 bilobated flaps were successfully resected, carrying 36 superficial peroneal artery perforators, all of which were septocutaneous perforators with the caliber of 0.2-0.8 mm. The caliber of superficial peroneal artery was 0.4-1.1 mm and the length of vascular pedicle was 3-8 cm. After operation, all the flaps survived with no vascular crisis occurred, and the wounds in donor and recipient sites healed well. During the follow-up of 6 to 12 months, the color and texture of flaps were similar to those of normal tissue in the hand and the appearance of flap was good in 10 cases; the other 5 cases underwent the stage Ⅱ flap thinning and plastic surgery 6 months after operation due to the bloated appearance of flaps. There was only linear scar in the donor site of lower leg, with no obvious scar hyperplasia or pigmentation, and there was no obvious adverse effect on the sensation or motor function of the distal limbs in the donor area. At the last follow-up, the repair effect of flap of 15 patients was excellent in 11 cases and good in 4 cases, and the sensory function of the flap was evaluated as grade S 2 in all cases. Conclusions:The bilobated superficial peroneal artery perforator flap has high proportion of septocutaneous perforator, and the blood supply is sufficient and reliable. Using this flap to repair two adjacent wounds of the fingers causes minimal damage to the donor area, only one group of blood vessels is needed to be anastomosed to repair two wounds, the difficulty of microoperation is reduced, and good flap repair effect and sensory function can be obtained.

Objective:To investigate clinical effects of anterolateral thigh flap with blood supply source of medial femoral perforator in repairing the wounds on extremities.Methods:A retrospective observational study was conducted. From October 2018 to June 2021, Suzhou Ruihua Orthopedic Hospital admitted 12 patients (11 males and 1 female, aged 24-64 years) who met the inclusion criteria, and did not have the lateral circumflex femoral artery during anterolateral thigh flap resection, or changed to medial femoral perforator as a source of blood supply due to small perforator to repair the wound with flap transplantation. The wounds were on the upper limbs in 7 cases and on the lower limbs in 5 cases. The wound area after debridement was 8.0 cm×5.0 cm-24.0 cm×6.5 cm, and the applied flap area was 9 cm×6 cm-25 cm×7 cm. During transplantation, the perforating branch or source artery of the flap was anastomosed end to end with the vascular pedicle of the recipient area. Subcutaneous beauty suture was performed on all the donor wounds. After operation, the survival of the flap and vascular crisis were observed; and the wound healing at the donor site was observed. During follow-up, the texture of the flap and complications at the donor site were observed. At the last follow-up, the effect of flap repair was evaluated by using the modified self-made comprehensive efficacy rating table.Results:After operation, all the flaps of patients survived without vascular crisis; the wounds in the donor site healed smoothly. During follow-up of 6 to 26 months, the flaps had good texture; only linear scars remained in the donor area without scar contracture, pain or other discomfort. At the last follow-up, the total score of flap repair effect of 12 patients was 75-95, with an average of 87, of which 5 cases were rated as excellent, 6 cases as good, and 1 case as fair, and the proportion of excellent and good patients was 11/12.Conclusions:The application of anterolateral thigh flap with blood supply from the medial femoral perforator to repair wounds on extremities is an alternative method for the vascular variations such as no descending branch, oblique branch, or small perforator of the lateral circumflex femoral artery during the resection of the anterolateral thigh flap. This operation has the advantages of simple operation, small trauma, and others, which effectively ensures the smooth operation.

The clinical data of 5 patients with occupational contact dermatitis caused by methyl chlorobutyrate treated in the Affiliated Hospital of Jining Medical College and Mamiao Township Hospital of Jinxiang County from September to October 2021 were retrospectively analyzed. Patients were all males aged 33-47 years with a history of exposure to methyl chlorobutyrate 1 to 4 d before the onset of symptoms. Three patients were hospitalized and 2 patients were treated in outpatient clinic. The clinical manifestations were erythema on the trunk or extremities of varying degrees, scattered with blisters and bullae of different sizes, with thin and clear blisters, local ulceration and exudation; no erosion or ulceration was found in the oral cavity and vulva. All 5 patients had elevated white blood cell counts, and 2 patients had abnormal liver function. All patients received symptomatic treatment with topical drugs. Three hospitalized patients were given methylprednisolone and loratadine; in addition, 1 case also received human immunoglobulin and moxifloxacin hydrochloride injection and 2 cases received hepatoprotective drugs. Two outpatients were given prednisone acetate and loratadine for treatment. Three hospitalized patients were all improved and discharged after 14-30 d of treatment. The rash of 2 outpatients subsided after 14 d of treatment, and there was no recurrence after 1-month follow-up. The occupational contact dermatitis caused by methyl chlorobutyrate is primary irritant contact dermatitis, often manifested as erythema and blisters on the trunk or limbs, and timely anti-allergic treatment can effectively control the disease.

Objective:To explore the feasibility of an "ABC" three line perforator locating method in design and harvest of free anterolateral perforator flap of calf.Methods:Between March 2021 and November 2021, 42 patients with 62 wounds on hand and foot were treated in the Department of Hand Surgery, Suzhou Ruihua Orthopaedic Hospital. The "ABC" three line perforator locating method was applied to determine the location and source of perforating branch before operation and to guide the design and harvest of flap during operation in wound reconstruction. Among the 42 patients, 24 had the injury of single digit, 7 had the injuries with 2 digits, 4 with 3 digits, 1 with 4 digits, 1 of the first web, 1 in the wrist, 2 of the great toe, 1 of second toe and 1 in dorsal foot. The sizes of soft tissue defect were 1.5 cm×2.0 cm-3.0 cm×14.0 cm. The sizes of the flaps were 2.0 cm×2.5 cm-3.5 cm×15.0 cm. All donor sites were sutured directly. In the follow-up, sensations of flaps were evaluated following the sensory function evaluation standard of British Medical Research Council(BMRC), and the recovery of the donor and recipient sites was evaluated by the flap comprehensive evaluation scale. Regular follow-up were scheduled at outpatient clinic.Results:A total of 162 perforators were located before operation. There were 95 perforating branches being explored in the operation, of which 5 patients had 1 extra perforating branch than that located before surgery. Seventy-six perforating branches were found consistent with preoperative localisation, with a coincidence rate of 84.4%(76/90). Sixty-four perforating branches were found consistent with the preoperative source with an accuracy rate of 84.2%(64/76). All the 62 flaps survived without a vascular compromise. Follow-up lasted for 6-10(mean 7.1) months. The colour and texture of the flaps were excellent. The flaps were thin and wear-resistant. The sensory function of the flaps was evaluated at S 1-S 3 by BMRC. Comprehensive evaluation scale of flap was excellent in 38 patients and good in 4 patients. Conclusion:"ABC" three line perforator locating method in design of free anterolateral calf flap is a feasible and an ideal auxiliary method in surgical practice. It combines anatomical knowledge, clinical experience and Doppler ultrasound localisation as well as accurately guides the location and source prediction of perforator before surgery.

Objective:To investigate the clinical effect of facial depression correction by using free anterolateral thigh adipofascial flap and human acellular dermal matrix.Methods:Nineteen facial depression patients (3 males and 16 females), age ranges from 16 to 56 years (average age: 29.1±10.37 years), caused by different reasons were selected in this research from Jan. 2008 to Dec. 2020. In the stage I operation, anterolateral thigh adipofascial flap was designed according to facial depression area and harvested to fill in the depression with vascular anastomosis; In the stage II operation, the human acellular dermal matrix was used to fill in the remained depression edge according to facial subunit.Results:All free anterolateral thigh adipofascial flap survived well. All patients revealed fascial subunit tissue atrophy of different degree in infraorbital, nasolabial sulcus and temporal areas which were repaired by using cellular dermal matrix and obtained satisfying effect during 1 to 8 years of follow-up with no obvious rejection. 18 of 19 patients showed flap hypertrophy and corrected by liposuction. All patients recovered well after 1 to 8 years of follow-up.Conclusions:Humana cellular dermal matrix could make up the limitations of treating fascial depression deformity when using anterolateral thigh adipofascial flap. The combination method of above approaches could obtain satisfying clinical effect, which is worthy of clinical promotion.

Objective:To investigate the feasibility and clinical outcome of anterolateral thigh flaps (ALTF) based on the transverse branch of the lateral circumflex femoral artery (LCFA) as the source artery in the repair of soft tissue defects of the extremities.Methods:A retrospective analysis was conducted to analyze the clinical data from patients who received the ALTF pedicled with the transverse branch of the LCFA to repair the wounds of the extremities from April 2020 to March 2021 at Ruihua Affiliated Hospital of Soochow University. Preoperative Doppler ultrasound was applied to locate the perforators in the anterolateral thigh area. The ALTF was prepared based on the traditional method, and the perforators were found to be too thin to meet the requirements of vascular anastomosis. The incision was extended superiorly, and the designated perforators were found in the upper segment; thus, the flap was harvested accordingly. The ALTF pedicled with the transverse branch of the LCFA was finally harvested for wound reconstruction. The donor site was directly drawn and sutured. The wound healing of the donor site and the survival rate of the flap were recorded. The comprehensive evaluation scale was used to evaluate the repair effect, which was classified as excellent (90-100 points), good (75-89 points), fair (60-74 points), and poor (<60 points).Results:Thirteen patients with extremity trauma were enrolled in the study, which consisted of nine males and four females. The age range was between 20 and 65 years old. There were 4 cases of hand/forearm wounds and 9 cases of foot/ankle wounds among the patients. The area of soft tissue defects was approximately 7 cm×4 cm to 31 cm×8 cm. Eighteen perforators from the transverse branches of the LCFA, including ten septocutaneous perforators and eight direct cutaneous perforators, were observed in thirteen surgeries. The area of flaps ranged 8 cm×6 cm to 32 cm×10 cm. One flap exhibited arterial crisis, which was relieved after thrombectomy and re-anastomosis of the injured segment; the flap survived. Other flaps survived completely. Thirteen patients were followed up for 6-20 months, and both flaps were soft in texture and good in appearance. In addition, there were no serious complications at the donor site. Finally, the curative effects of the ALTF pedicled with the transverse branch of the LCFA were estimated according to the flap comprehensive evaluation scale. Four cases obtained excellent curative effects, seven cases had good prognoses, and the effects of the remaining two cases were acceptable.Conclusions:The ALTF pedicled with the transverse branch of the LCFA can be used to repair soft tissue defects of the extremities, with a good prognosis obtained; meanwhile, the anatomy of the perforators is simple, and the donor area is relatively inconspicuous. The flap can be a useful supplement to the conventional ALTF.