ObjectiveTo compare drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, completion and results publication.MethodsWe randomly selected 190 clinical trials that were registered in ClinicalTrials.gov from 2009 to 2014, and followed up to December 31st, 2019. Comparisons were made for the type of sponsor, phase, design, and completion status by the sponsor’s country.ResultsAmong all included clinical trials, trials from the United States, Europe, Japan and China accounted for 50.5%, 34.2%, 9.0% and 6.3%, respectively. Among these trials, 71.1% had been completed and 69.5% disclosed results had been published publicly prior to the end of follow-up, and differences between countries were statistically significant (P<0.05). Two-thirds of the trials in China were phase Ⅲ/Ⅳ trials; in contrast, most of the clinical trials in the United States and Europe were phase Ⅰ/Ⅱ trials. The proportion of using double-blind, randomized controlled trial design was the highest in the United States (46.9%) and the lowest in China (8.3%). Chinese sponsors were mostly hospitals/universities (58.3%), while in other countries drug trials were mostly sponsored by the industry and in Japan the proportion was as high as 94.0%.ConclusionsThe number of drug trials registered in ClinicalTrials.gov from China is small and these trials are less likely to be completed and have results published/disclosed. Pharmaceutical companies in China should pay more attention to the public registration of their clinical trials, particularly those in early phases, and improve trial design and management.
Objective To investigate the effectiveness of free superficial circumflex iliac artery flap (SCIP) combined with deep inferior epigastric perforator flap (DIEP) in repairing large soft tissue defects of upper extremities. MethodsBetween February 2017 and January 2021, free SCIP combined with DIEP was used to repair 15 patients with large soft tissue defects of upper extremities. There were 12 males and 3 females, aged from 34 to 52 years, with a median age of 41 years. The causes of injury were mechanical injury in 11 cases and traffic accident injury in 4 cases. There were 9 cases of circular skin defect in the forearm and 6 cases of skin defect around the upper arm and elbow joint, with the defect in size of 15.5 cm×10.5 cm to 26.5 cm×15.5 cm, accompanied by exposure of deep tissues such as tendons and bones. There were 7 cases with open fractures and 8 cases with vascular and nerve injuries. The time from injury to operation ranged from 7 to 14 days, with an average of 7.5 days. The flaps in size of 16.0 cm×11.0 cm to 27.0 cm×16.0 cm were harvested; the thickness of the flaps was 0.8-1.3 cm, and the excess fat tissue was removed under the microscope after harvesting. The length of proximal vascular pedicle was 5.0-7.0 cm, and of distal vascular pedicle was 3.0-5.0 cm. The donor site was closed and sutured directly, and the navel was reconstructed. Results The flaps survived successfully in 14 cases, and the arterial crisis occurred in 1 case at 10 hours after operation, and the flap survived after surgical exploration. All the wounds in the donor and recipient sites healed by first intention. All 15 patients were followed up 3-14 months, with an average of 10.5 months. The appearance, elasticity, and texture of flap were good without obvious bloat, contracture, or adhesion. The donor site healed well, no abdominal wall hernia was found, and the appearance of reconstructed navel was good, only linear scar left. At last follow-up, 12 cases were evaluated as excellent and 3 cases were good according to the evaluation criteria of flap function of the Chinese Medical Association Microsurgery Branch. The sensation recovered to \begin{document}${\rm{S}}_{3^+} $\end{document} in 7 cases and \begin{document}${\rm{S}}_3 $\end{document} in 8 cases. ConclusionFree SCIP combined with DIEP has a large excision area and excellent skin ductility. It is an effective clinical method for repairing large soft tissue defects of upper extremities.
ObjectiveTo investigate the effectiveness of abdominal free flap carrying bilateral superficial circumflex iliac arteries for repairing large skin and soft tissue defects of foot and ankle.MethodsBetween June 2016 and June 2019, 15 patients with large skin and soft tissue defects of foot and ankle were admitted, including 10 males and 5 females with an average age of 30 years (range, 10-60 years). The causes of injury included 6 cases of traffic accident, 3 cases of machine strangulation, 3 cases of heavy object injury, 2 cases of fall, and 1 case of electric shock. The time from injury to admission was 3 hours to 10 days, with an average of 2 days. The wound located at dorsal foot in 5 cases, ankle in 6 cases, dorsal foot and ankle in 3 cases, and dorsal foot and sole in 1 case. All wounds were contaminated to varying degrees and accompanied by tendon and bone exposure, including 5 cases of extensive necrosis of the dorsal skin with infection. The area of defects ranged from 18 cm×6 cm to 25 cm×8 cm. There were 9 cases of foot and ankle fractures and dislocations, and 2 cases of foot and ankle bone defects. The wound was repaired with abdominal free flap carrying bilateral superficial circumflex iliac arteries. The area of the flaps ranged from 20 cm×8 cm to 27 cm×10 cm; the skin flaps were thinned under the microscope to make the thickness of 0.5-1.0 cm, with an average of 0.7 cm. All incisions at the donor site were sutured directly.ResultsDuring the operation, 1 case was replaced with an abdominal free flap carrying the superficial abdominal artery because the superficial iliac circumflex artery was thin and the superficial abdominal artery was thicker. The skin flaps of 15 cases survived smoothly, and the wounds healed by first intention; the donor incisions all healed by first intention. All patients were followed up 8-36 months, with an average of 15 months. The flap shape was satisfactory, with good texture and mild pigmentation of the flap edge, without obvious bloating, effect on shoe wear, or secondary surgical thinning of the flap. The linear scar left in the donor site and had no effect on hip joint movement. All fractures healed well, and the healing time ranged from 3 to 8 months, with an average of 6 months.ConclusionThe abdominal free flap carrying bilateral superficial iliac circumflex arteries has concealed donor site, with little damage, and can be sutured in one stage. The blood vessel is anatomically constant, with less variation, and reliable blood supply. It is one of the ideal flaps for repairing large skin and soft tissue defects of foot and ankle.