Reduction of groin wound complications in vascular surgery patients using closed incision negative pressure therapy (ciNPT): a prospective,randomised, single‐institution study

Groin wound infections in patients undergoing vascular procedures often cause a lengthy process of wound healing. Several clinical studies and case reports show a reduction of surgical site infections (SSIs) in various wound types after using closed incision negative pressure therapy (ciNPT). The aim of this prospective, randomised, single‐institution study was to investigate the effectiveness of ciNPT (PREVENA™ Therapy) compared to conventional therapy on groin incisions after vascular surgery. From 1 February to 30 October 2015, 100 patients with 129 groin incisions were analysed. Patients were randomised and treated with either ciNPT (n = 58 groins) or the control dressing (n = 71 groins). ciNPT was applied intraoperatively and removed on days 5–7 postoperatively. The control group received a conventional adhesive plaster. Wound evaluation based on the Szilagyi classification took place postoperatively on days 5–7 and 30. Compared to the control group, the ciNPT group showed a significant reduction in wound complications (P < 0·0005) after both wound evaluation periods and in revision surgeries (P = 0·022) until 30 days postoperatively. Subgroup analysis revealed that ciNPT had a significant effect on almost all examined risk factors for wound healing. ciNPT significantly reduced the incidence of incision complications and revision procedures after vascular surgery.     

A new nomogram score for predicting surgery‐related pressure ulcers in cardiovascular surgical patients

The aim of this study was to build a new nomogram score for predicting surgery‐related pressure ulcers (SRPU) in cardiovascular surgical patients. We performed a prospective cohort study among consecutive patients with cardiovascular surgery between January 2015 and December 2015. Univariate and multivariate logistic regression was used to analyse the risk factors for SRPU. A nomogram‐predicting model was built based on the logistic regression model. Then, calibration and discrimination were tested. A total of 149 patients with cardiovascular surgery were included in the study. Thirty‐seven patients developed SRPUs, with an incidence rate of 24·8% (95%CI: 18·1–32·6%). The logistic regression model for predicting SRPU with four risk factors was Logit(P) = (1·861 × VDH, OR 2·174 × CAD, OR 1·747 × TAA) − 0·029 × weight + 0·005 × surgery duration + 1·241 × perioperative corticosteroids administration (P = 0·003, R² = 0·1181). The goodness‐of‐fit test (Pearson χ ² = 150·69, P = 0·217) indicated acceptable calibration, and the C‐index (0·725) indicated moderate discrimination. When the probability cut‐off is 0·25 (total score 12), the nomogram model has the best sensitivity and specificity in predicting SRPU. We established a new nomogram model that can provide an individual prediction of SRPU in cardiovascular surgical patients. When the probability is more than 0·25 (total score 12), the cardiovascular surgery patients should be considered at high‐risk.     

A Prospective Randomized Study Comparing Non-absorbable Polypropylene (Prolene®) and Delayed Absorbable Polyglactin 910 (Vicryl®) Suture Material in Mass Closure of Vertical Laparotomy Wounds

Wound dehiscence is a postoperative complication encountered following abdominal surgery. A prospective randomized study was conducted to compare the incidence of wound dehiscence with a delayed absorbable and a nonabsorbable suture material in the mass closure of vertical laparotomy wounds. In one group, 100 patients were analyzed after closure with Prolene®, and in another group, 100 patients were analyzed after closure with Vicryl®. The incision was closed by continuous far and near suture technique using polypropylene (Prolene) suture in one group and a synthetic delayed absorbable polyglactin 910 (Vicryl) suture in the other group. There was significant difference in the incidence of wound dehiscence between the two groups: 6 % with Prolene and 17 % with Vicryl, (χ² = 5.944, 1 DF, P value = 0.0148). The overall incidence of wound dehiscence was 11.5 % in this study. The incidence of wound dehiscence in both the study groups was higher than expected as compared to previous literature. There was a significant difference between the two suture materials. In our study, Prolene is a better suture material for closure of vertical laparotomy wounds.     

Using image J to document healing in ulcers of the foot in diabetes

The aim of the study was to assess the reliability of measuring the cross‐sectional area of diabetic foot ulcers using Image J software. The inter‐ and intra‐rater reliability of ulcer area measures were assessed using digital images of acetate tracings of ulcers of the foot affecting 31 participants in an off‐loading randomised trial. Observations were made independently by five specialist podiatrists, one of whom was experienced in the use of Image J software and educated the other four in a single session. The mean (±SD) of the mean cross‐sectional areas of the 31 ulcers determined independently by the five observers was 1386·7 (±22·7) mm². The correlation between all pairs of observers was >0·99 (P < 0·001). There was no significant difference overall between the five observers (ANOVA F1.538; P = 0·165) and no difference between any two (paired samples test t = −0·787–1·396; P ≥ 0·088). The correlation between the areas determined by two observers on two occasions separated by not less than 1 week was very high (0·997 and 0·999; P < 0·001 and <0·001, respectively). The inter‐ and intra‐reliability of the Image J software is very high, with no evidence of a difference either between or within observers. This technique should be considered for both research and clinical use in order to document changes in ulcer area.     

Efficacy and safety of triamcinolone acetonide alone and in combination with 5‐fluorouracil for treating hypertrophic scars and keloids: a systematic review and meta‐analysis

Pathological scars, such as keloids and hypertrophic scars, readily cause physical and psychological problems. Combination 5‐fluorouracil (5‐FU) with triamcinolone acetonide (TAC) is presumed to enhance the treatment of pathological scars, although supportive evidence is lacking. We aimed to compare the efficacy and safety of TAC alone and in combination with 5‐FU for the treatment of hypertrophic scars and keloids. Five databases (PubMed, Medline, Cochrane databases, Embase and CNKI) were searched with the limitations of human subjects and English‐language text. Mean differences (MDs), odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. The Cochrane Collaboration''s Risk of Bias Tool was used to assess the risk of bias. The control group received intralesional TAC alone, and the experimental group received TAC combined with 5‐FU injection. A pooled analysis of the effectiveness based on patient self‐assessment after treatment showed that the experimental group achieved better results than the control group (OR = 2·92, 95% CI = 1·63–5·22, P = 0·0003). Similarly, a pooled analysis of the effectiveness based on observer assessment following treatment produced the same conclusion (OR = 4·03, 95% CI = 1·40–11·61, P = 0·010). A meta‐analysis of scar height after treatment showed that the experimental group performed better than the control group (MD = −0·14, 95% CI = −0·23–0·05, P = 0·002). The erythema score of the experimental group after treatment was superior (MD = −0·20, 95% CI = −0·34–0·06, P = 0·004). The heterogeneity test showed no heterogeneity among the studies (P > 0·1, I ² = 0%). TAC combined with 5‐FU is more suitable for the treatment and prevention of hypertrophic scars and keloids, with greater improvement in scar height and patient satisfaction as well as fewer side effects.     

Effect of Multiple Doses of Intravenous Tranexamic Acid on Perioperative Blood Loss in Total Knee Arthroplasty: A Randomized Controlled Study

ObjectiveTo identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV‐TXA) following primary total knee arthroplasty (TKA) with a tourniquet.MethodsThis is a single‐blind randomized controlled study that recruited osteoarthritis patients who had undergone primary unilateral TKA from May 2019 to May 2020 at our medical center. A total of 300 patients were randomly divided into three groups to receive: one dose (1 g) of IV‐TXA before skin incision combined with one dose (1.5 g) of intra‐articular tranexamic acid（IA‐TXA) followed by a single dose of IV‐TXA (1 g) for 3 h (group A); two doses of IV‐TXA (1 g) for 3 and 6 h (group B); or three doses of IV‐TXA (1 g) for 3, 6, and 12 h (group C) postoperatively. TKA with a tourniquet was performed by the same surgical team. The primary outcomes were total blood cell loss (TBL), hidden blood loss (HBL), maximum hemoglobin (Hb) drop, and transfusion rate. Secondary outcomes were levels of C‐reactive protein (CRP) and D‐dimer, and the incidence of postoperative complications. One‐way analysis of variance, subgroup analysis, and multivariate correlation analysis were used to calculate the differences among the three groups.ResultsThe study included 56 male and 244 female patients aged 60–80 years. The mean TBL, the mean HBL, and the maximum Hb drop in group C (471.2 ± 190.6 mL, 428.4 ± 190.3 mL, and 21.2 ± 3.8 g/L, respectively) were significantly lower than those in groups B (563.4 ± 224.6 mL, P = 0.030; 519.9 ± 226.4 mL, P = 0.033; and 23.2 ± 4.1 g/L, P = 0.001, respectively), and A (651.6 ± 254.1 mL, P < 0.001; 607.1 ± 254.3 mL, P < 0.001; and 25.1 ± 4.3 g/L, P < 0.001, respectively). No transfusions were required. The postoperative acute inflammatory reaction was less problematic for patients in Group C, and the incidence of thromboembolic events was similar among the groups (P > 0.05). In addition, there were positive correlations between the HBL and the tourniquet inflation time (r = 0.844, P < 0.001). Similarly, the level of CRP on POD1 (r = 0.393, P < 0.001) and POD3 (r = 0.149, P = 0.010), and the level of D‐dimer on POD1 (r = 0.382, P < 0.001) were positively correlated with the HBL.ConclusionThree doses of postoperative IV‐TXA decreased blood loss and diminished the postoperative inflammatory and fibrinolytic response more than a single dose or two doses in elderly patients following TKA without increasing the incidence of adverse events.     

Efficacy and Safety of Ultrasonic Bone Curette‐assisted Dome‐like Laminoplasty in the Treatment of Cervical Ossification of Longitudinal Ligament

ObjectiveTo assess the efficacy and safety of ultrasonic bone curette‐assisted dome‐like laminoplasty in the treatment of ossification of longitudinal ligament (OPLL) involving C₂.MethodsA total of 64 patients with OPLL involving C₂ level were enrolled. Thirty‐eight patients who underwent ultrasonic bone curette‐assisted dome‐like laminoplasty were defined as ultrasonic bone curette group (UBC), and 28 patients who underwent traditional high‐speed drill‐assisted dome‐like laminoplasty were defined as high‐speed drill group (HSD). Patient characteristics such as age, sex, body mass index (BMI), symptomatic duration, and other information like the type of OPLL, the time of surgery, blood loss, C₂–C₇ Cobb angle change and complications were all recorded and compared. The Japanese Orthopaedic Association (JOA) score, the nerve root functional improvement rate (IR), and the visual analogue scale (VAS) were used to assess neurological recovery and pain relief. The change of the distance between the apex of ossification and a continuous line connecting the anterior edges of the lamina was measured to assess the spinal expansion extent. The measured data were statistically processed and analyzed using SPSS 21.0 software, and the measurement data were expressed as mean ± SD.ResultsIn ultrasonic bone curette (UBC) group and high‐speed drill group (HSD) group, the average time for laminoplasty was 52.3 ± 18.2 min and 76.0 ± 21.8 min and the mean bleeding loss volume was 155.5 ± 41.3 mL and 177.4 ± 54.7 mL, respectively, with a statistically significant difference between the groups. Both groups demonstrated a significant improvement in neurological function. However, the VAS score in UBC group was lower than in HSD group at the 6‐month follow‐up (P < 0.05), but there was no significant difference at 1‐year follow‐up. We found that the loss of lordosis was 1.5° ± 1.0° in UBC group, which is significantly lower than that of HSD group at 1‐year follow‐up (3.8° ± 1.2°, P < 0.05). According to the change of canal dimension, we found that the expansion extent of the spinal canal in UBC group was similar to that of HSD group (P > 0.05). Only one patient in the UBC group and five patients in the HSD group displayed cerebrospinal fluid (CSF) leakag.ConclusionsWith the use of ultrasonic bone curette in OPLL dome‐like decompression, the decompression surgery could be completed relatively safely and quickly. It effectively reduced the amount of intraoperative blood loss and complications, and had better initial recovery of neck pain.     

Impact of negative‐pressure wound therapy on bacterial behaviour and bioburden in a contaminated full‐thickness wound

The use of negative‐pressure wound therapy (NPWT) has displayed significant clinical benefits in the healing of infected wounds. However, the effects of NPWT on bacterial colonisation and infection of traumatic wounds has been controversial. The aim of this study is to evaluate the impact of NPWT treatment in rabbits with a contaminated full‐thickness wound on bacterial behaviour, including colony morphology, spatial distribution, fissional proliferation, and bacterial bioburden. Full‐thickness wounds were created on the back of rabbits, and were inoculated with bioluminescent Staphylococcus aureus. The wounds were treated with sterile gauze dressings and NPWT with continuous negative pressure (−125 mm Hg). Wound samples were harvested on days 0 (6 hours after bacterial inoculation), 2, 4, 6, and 8 at the centre of wound beds before irrigation. Scanning electron microscopy and transmission electron microscopy (TEM) analyses were performed to determine the characteristic bacteriology. Laser scanning confocal microscopy was performed to obtain bioluminescent images, which were used to observe spatial distribution of the GFP‐labelled S. aureus within the tissue and quantify the bacterial bioburden. NPWT resulted in sparse amounts of scattered bacteria on the wound surface or as sparsely spaced single colonies within the tissue. Wound bioburden on day 8 in the NPWT and gauze groups was 34.6 ± 5.5% and 141.9 ± 15.4% of the baseline values (N = 6), respectively (P < .0001). TEM showed a lack of S. aureus active fission within NPWT‐treated tissue. NPWT can impact S. aureus colony morphology and spatial distribution both on the surface and within wound tissue, and reduce S. aureus as early as 48 hours after therapy initiation. Additionally, NPWT inhibits bacterial fissional proliferation in microcolonies.     

Impact of COVID‐19 on wound care in Germany

Recent studies showed that the COVID‐19 pandemic caused collateral damage in health care in terms of reduced hospital submissions or postponed treatment of other acute or chronic ill patients. An anonymous survey was sent out by mail to patients with chronic wounds in order to evaluate the impact of the pandemic on wound care. Sixty‐three patients returned the survey. In 14%, diagnostic workup or hospitalisation was cancelled or postponed. Thirty‐six percent could not seek consultation by their primary care physician as usual. The use of public transport or long travel time was not related to limited access to medical service (P = .583). In ambulatory care, there was neither a significant difference in the frequency of changing wound dressings (P = .67), nor in the person, who performed wound care (P = .39). There were no significant changes in wound‐specific quality of life (P = .505). No patient used telemedicine in order to avoid face‐to‐face contact or anticipate to pandemic‐related restrictions. The COVID‐19 pandemic impaired access to clinical management of chronic wounds in Germany. It had no significant impact on ambulatory care or wound‐related quality of life. Telemedicine still plays a negligible role in wound care.     

The Effect of a PEEK Material‐Based External Fixator in the Treatment of Distal Radius Fractures with Non‐Transarticular External Fixation

ObjectiveTo explore the effect of a PEEK material‐based external fixator in the treatment of distal radius fractures with non‐transarticular external fixation.MethodsThere were 48 patients in this prospective comparative study. They were divided into two groups according to the materials used: the PEEK group and the titanium group. Wrist dorsiflexion, palmar flexion, pronation, supination, radial deviation, ulnar deviation, grip strength of the palm on the affected side, kneading force, Visual Analogue Scale/Score (VAS), Disabilities of the Arm, Shoulder, and Hand (DASH) score, operation time, frequency of fluoroscopy procedures, and X‐ray results were compared between the two groups. Functional recovery was evaluated at the last follow‐up according to the wrist joint evaluation criteria.ResultsThe baseline data were comparable between the two groups, and no significant differences were found in age, sex, fracture types (P > 0.05). There was no significant difference between the two groups in the results of DASH, grip strength, and recovery of pinch force and wrist function (dorsiflexion, clavicle, ulnar deviation, deviation, pronation, and supination) (P > 0.05). Normal limb function was achieved in the two groups of patients at an average of 6 weeks after surgery, and there was no significant difference in X‐ray examination radial height (10.60 ± 1.59 vs 11.00 ± 1.53, P = 0.687), radial inclination (1.11 ± 0.24 vs 1.12 ± 0.24, P = 0.798), volar tilt (10.33 ± 2.13 vs 10.00 ± 2.08, P = 0.660), ulnar variance (20.87 ± 3.00 vs 20.38 ± 3.04, P = 0.748), and step‐off persistence (1.73 ± 0.69 vs 1.68 ± 0.72, P = 0.425) between the two groups (P > 0.05). However, the operation time (54.80 ± 12.20 vs 85.23 ± 15.14, P = 0.033) and number of fluoroscopy procedures (36.93 ± 6.89 vs 64.77 ± 9.74, P = 0.000) in the PEEK group were significantly reduced compared with those in the titanium group.ConclusionCompared with the traditional titanium external fixator, the PEEK composite external fixator has advantages, such as a shorter operation time and fewer fluoroscopy procedures when used to treat different types of distal radius fracture.     

Investigation of the status and influence factors of caregiver's quality of life on caring for patients with chronic wound during COVID‐19 epidemic

The objectives of this study were to investigate the status and influence factors of caregiver''s quality of life (QOL) on caring for patients with chronic wound during COVID‐19 epidemic. A prospective cross‐sectional study of 83 informal caregivers was included. The characteristics of informal caregivers as well as their QOL assessment by the Family Dermatology Life Quality Index (FDLQI) were measured, respectively. Single‐factor analysis and multiple regression analysis were carried out to explore the independent influence factors of QOL of caregiver on caring for patient with chronic wound. 62.65% of the caregivers were female with a mean age of (54.24 ± 12.6) years, and 34.9% of the caregivers were parents. The mean FDLQI score was 13.01 ± 7.53 at a high level. The following variables influenced the FDLQI scores of caregivers: self‐care ability of patients, patient''s satisfaction of home‐based wound care, and home‐based wound care need of caregivers. The model was able to explain 29.9% of variance in QOL of caregiver (F = 6.561, P = .000, R ² = 0.299, adjusted R ² = 0.253). In conclusion, the impact of chronic wound disease on the QOL of caregivers is heavy during COVID‐19 epidemic. Wound professionals are suggested to pay attention to wound care need at home and QOL of caregiver on caring for patients with chronic wound during COVID‐19 epidemic and develop tailored wound health education and support programme in order to improve the QOL of caregivers.     

Correlation of Acetabular Anteversion and Thoracic Kyphosis Postoperatively with Proximal Junctional Failure in Adult Spinal Deformity Fused to Pelvis

ObjectivesTo investigate whether the immediate thoracic kyphosis (TK) and acetabular anteversion (AA) postoperatively are correlated with proximal junctional failure (PJF) in adult spinal deformity (ASD) patients underwent surgical treatment.MethodsThis is a retrospective study. Following institutional ethics approval, a total of 57 patients (49 Female, eight Male) with ASD underwent surgery fused to sacroiliac bone (S1, S2, or ilium) from March 2014 to January 2019 were included. All of those patients were followed up for at least 2 years. Demographic, radiographic and surgical data were recorded. The maximum range of flexion motion (F‐ROM) and extension motion (E‐ROM) actively of hip joints was measured and recorded at pre‐ and postoperation. The sum of F‐ROM and E‐ROM was defined as the range of hip motion (H‐ROM). Receiver operating characteristic (ROC) curve analysis was used to obtain the cut off value of parameters for PJF. A Kaplan–Meier curve and log‐rank test were used to analyze the differences in PJF‐free survival.ResultsIn all, 14 patients developed PJF during follow‐up. Comparisons between patients with and without PJF showed significant differences in immediate TK (P < 0.001) and AA (P = 0.027) postoperatively. ROC curve analysis determined an optimal threshold of 13° for immediate AA postoperatively (sensitivity = 74.3%, specificity = 85.7%, area under the ROC curve [AUC] = 0.806, 95% CI [0.686–0.926]). Nineteen patients with post‐AA ≤13° were assigned into the observational group, and 38 patients with post‐AA >13° were being as the control group. Patients in the observational group had smaller H‐ROM (P = 0.016) and F‐ROM (P < 0.001), but much larger E‐ROM (P < 0.001). There were 10 patients showing PJF in the observational group and four in the control group (10/9 vs 4/34, P < 0.001). PJF‐free survival time significantly decreased in the observational group (P = 0.001, log‐rank test). Furthermore, patients in the observational group had much larger TK (post‐TK, P = 0.015). The optimal threshold for post‐TK (sensitivity = 85.7%, specificity = 76.7%; AUC = 0.823, 95% CI [0.672–0.974]) was 28.1° after the ROC curve was analyzed. In the observational group, those patients with post‐TK ≥28.1° had significantly higher incidence of PJF (9/2 vs 1/7, P < 0.001) than those with post‐TK < 28.1°. Moreover, PJF‐free survival time in those patients significantly decreased (P = 0.001, log‐rank test).ConclusionsASD patients with acetabular anteversion of ≤13° at early postoperation may suffer significantly restricted hip motion and much higher incidence of PJF during follow‐up, moreover, in those patients, postoperative TK ≥28.1° would be a significant risk factor for PJF developing.     

Cross‐sectional correlations between the toe brachial index and lower limb complications in older people

The aim of the study was to investigate the relationship between the toe brachial index (TBI) and foot ulceration and amputation in older people. Two hundred and sixty‐one participants meeting guidelines for lower limb vascular assessment had their toe and brachial blood pressure measured, medical records audited and signs and symptoms of peripheral arterial disease (PAD) recorded. Pearson''s correlation and linear regression analyses were performed to determine the strength of relationships between variables. Significant correlations were found between the TBI and painful symptoms (r = −0·35, P < 0·05) and foot complications (r = −0·31, P < 0·05). After adjusting for traditional risk factors for foot complications, participants with a TBI <0·70 were 19 times more likely to have a history of foot wounds or amputation (odds ratio = 19·20, 95% confidence interval (CI): 2·36–155·96, P < 0·001) than those with higher TBI values (>0·70). This preliminary study supports a TBI threshold of 0·70 for PAD diagnosis and indicates that lower values are associated with painful symptoms, history of ulceration and amputation. Future longitudinal investigation of the predictive capacity is now warranted.     

Biofilms and delayed healing – an in vitro evaluation of silver‐ and iodine‐containing dressings and their effect on bacterial and human cells

This study investigated whether there are differences in the ability of wound dressings to modulate certain factors known to affect wound healing. A selection of antimicrobial dressings (AQUACEL ^® Ag Extra^™, AQUACEL ^® Ag+ Extra^™, IODOFLEX ^™, ACTICOAT ^™ 7 and PROMOGRAN PRISMA^™ matrix) were tested for their effect on both bacterial bioburden and human dermal fibroblasts. Some dressings underwent further evaluation for activity against Pseudomonas aeruginosa biofilms using a colony‐drip flow reactor model. The ability of in vitro biofilms to produce proteases, and the effect of PROMOGRAN PRISMA matrix on such proteases, was also investigated. All antimicrobial dressings tested reduced vegetative bacterial load; however, only PROMOGRAN PRISMA matrix was able to significantly reduce biofilm populations (P = 0·01). Additionally, PROMOGRAN PRISMA matrix was the only dressing that did not inhibit dermal fibroblast growth. All other dressings were detrimental to cell viability. In vitro biofilms of Pseudomonas aeruginosa were demonstrated as being capable of releasing bacterial proteases into their surroundings, and incubation with PROMOGRAN PRISMA matrix led to a 77% reduction in activity of such proteases (P = 0·002). The unique ability of PROMOGRAN PRISMA matrix to reduce in vitro vegetative bacteria, biofilm bacteria and bacterial proteases while still allowing dermal fibroblast proliferation may help rebalance the wound environment and reduce the occurrence of infection.     

Influence of Cage Design on Radiological and Clinical Outcomes in Dorsal Lumbar Spinal Fusions: A Comparison of Lordotic and Non‐Lordotic Cages

ObjectivesTo evaluate the comparison between lordotic and non‐lordotic transforaminal lumbar interbody fusion (TLIF) cages in degenerative lumbar spine surgery and analyze radiological as well as clinical outcome parameters in long‐term follow up.MethodsIn a retrospective study design, we compared 37 patients with non‐lordotic cage (NL‐group) and 40 with a 5° lordotic cage (L‐group) implanted mono‐ or bi‐segmental in TLIF‐technique from 2013 to 2016 and analyzed radiological parameters of pre‐ and postoperative (Lumbar lordosis (LL), segmental lordosis (SL), and pelvic tilt (PT), as well as clinical parameters in a follow‐up physical examination using the Oswestry disability index (ODI), Roland–Morris Score (RMS), and visual analog scale (VAS).ResultsSurgery was mainly performed in lower lumbar spine with a peak in L4/5 (mono‐segmental) and L4 to S1 (bi‐segmental), long‐term follow‐up was on average 4 years postoperative. According to the literature, we found significantly better results in radiological outcome in the L‐group compared to the NL‐group: LL increased 6° in L‐group (51° preoperative to 57° postoperative) and decreased 1° in NL‐group (50° to 49° (P < 0.001). Regarding SL, we found an increase of 5° in L‐group (13° to 18°) and no difference in NL‐group (15°)(P < 0.001). In PT, we found a clear benefit with a decrease of 2° in L‐group (21° to 19°) and no difference in NL‐group (P = 0.008).In direct group comparison, ODI in NL‐group was 23% vs 28% in L‐group (P = 0.25), RMS in NL‐group was 8 points vs 9 points in L‐group (P = 0.48), and VAS was in NL‐group 2.7 vs 3.2 in L‐group (P = 0.27) without significant differences.However, the clinical outcome in multivariate analysis indicated a significant multivariate influence across ODI and RMS of BMI (Wilks λ = 0.57, F [4, 44] = 3.61, P = 0.012) and preoperative SS (Wilks λ = 0.66, F [4, 44] = 2.54, P = 0.048). Age, gender, cage type and postoperative PT had no significant influence (P > 0.05). Intraoperatively, we saw three dura injuries that could be sutured without problems and had no consequences for the patient. In the follow‐up, we did not find any material‐related problems, such as broken screws or cage loosening, also no pseudarthrosis.ConclusionIn conclusion, we think it''s not cage design but other influenceable factors such as correct indication and adequate decompression that lead to surgical success and the minimal difference in the LL therefore seemed to be of subordinate importance.     

Efficacy and safety of extracorporeal shock wave therapy for acute and chronic soft tissue wounds: A systematic review and meta‐analysis

This study aimed to evaluate and compare the effects of extracorporeal shock wave therapy (ESWT) and conventional wound therapy (CWT) for acute and chronic soft tissue wounds. All English‐language articles on ESWT for acute and chronic soft tissue wounds indexed in PubMed, Medline, Embase, Cochrane Central Register of Controlled Trials, Cochrane Library, Physiotherapy Evidence Database, and HealthSTAR published prior to June 2017 were included, as well as corresponding articles cited in reference lists of related review articles. The methodological quality of the selected studies was assessed with the Cochrane Collaboration''s “risk of bias” tool. Study design, subject demographics, wound aetiology, treatment protocols, assessment indexes, and follow‐up duration were extracted. The fixed or random‐effects model was used to calculate the pooled effect sizes according to studies’ heterogeneity. Ten randomised controlled trials (RCTs) involving 473 patients were included in this systematic review and meta‐analysis. The meta‐analysis showed that ESWT statistically significantly increased the healing rate of acute and chronic soft tissue wounds 2.73‐fold (odds ratio, OR = 3.73, 95% confidence interval, CI: 2.30‐6.04, P < .001) and improved wound‐healing area percentage by 30.45% (Standardized Mean Difference (SMD) = 30.45; 95% CI: 23.79‐37.12; P < .001). ESWT reduced wound‐healing time by 3 days (SMD = −2.86, 95% CI:‐3.78 to −1.95, P < .001) for acute soft tissue wounds and 19 days (SMD = −19.11, 95% CI: −23.74 to −14.47, P < .001) for chronic soft tissue wounds and the risk of wound infection by 53% (OR = 0.47, 95% CI: 0.24‐0.92, P = .03) when compared with CWT alone. Serious adverse effects were not reported. ESWT showed better therapeutic effects on acute and chronic soft tissue wounds compared with CWT alone. However, higher‐quality and well‐controlled RCTs are needed to further assess the role of ESWT for acute and chronic soft tissue wounds.     

Efficacy and Safety of Postoperative Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Prospective Randomized Controlled Study

ObjectiveTo assess the efficacy and safety of postoperative intravenous tranexamic acid (TXA) in patients undergoing total knee arthroplasty (TKA).MethodsFrom March 2020 to August 2020, all patients undergoing primary unilateral TKA in our hospital were considered in prospective randomized controlled study. Included patients were randomized into three groups to receive either two doses of 15 mg/kg intravenous TXA postoperatively, at 2 and 24 h after closing the incision (group A), or a single dose of 15 mg/kg intravenous TXA 2 h postoperatively (group B), or placebo (group C). The calculated total blood loss (TBL) and hidden blood loss (HBL), incidence of venous thromboembolism (VTE), and transfusion rate were compared among groups. The levels of prothrombotic state parameters including thrombomodulin (TM), thrombin‐anti‐thrombin complex (TAT), plasmin‐anti‐plasmin complex (PIC), and tissue‐type plasminogen activator‐plasminogen activator inhibitor complex (t‐PAI·C) in plasma were measured during the perioperative period. Patients were compared depending on the Kellgren‐Lawrence classification (K‐L types III and IV).ResultsAll patients were followed up for at least 4 weeks. The mean TBL and HBL in group C (1,182.45 ± 160.50; and 965.47 ± 139.61 mL, respectively) were significantly higher than those in groups A (944.34 ± 130.88 mL, P < 0.05; and 712.45 ± 129.82mL, P < 0.05, respectively) or B (995.20 ± 154.00 mL, P < 0.05; and 757.20 ± 134.39 mL, P < 0.05, respectively), but no significant differences were found between groups A and B (P > 0.05 and P > 0.05, respectively). None of the patients of three groups received blood transfusion, so there were no significant differences in blood transfusion rate among groups. Similar results were obtained with subgroups of patients who had the K‐L types III and IV. The DVT frequencies were four, three, and three in groups A, B, and C, respectively, with no significant differences after comparison (P > 0.05). There were no significant differences in the levels of prothrombotic state parameters (TM, TAT, PIC, t‐PAI·C) or incidence of VTE among groups (P > 0.05). Wound leakage was observed in five patients during the hospital stay (two patients in group A, one patient in group B, and two patients in group C), and no statistical difference was found in wound leakage or other complications among groups (P > 0.05).ConclusionsShort‐term application of postoperative intravenous TXA in TKAs resulted in reduced HBL without a measured increase in the actual incidence of VTE or the potential risk of thrombosis, but administration of TXA after the first 24 h had no significant effect.     

Refractory venous leg ulcers: observational evaluation of innovative new technology

This observational case series reports the evaluation of a novel neuromuscular electrical stimulation device (geko™) that stimulates the common peroneal nerve at the fibular head as an adjunctive therapy in patients with non‐healing venous leg ulcers. The aim was to evaluate and determine if the geko™ device was effective in this population and should be added to the medical supply formulary. Patients whose wounds had failed to heal within 24 weeks of standard therapy were identified in two community settings in Ontario. A total of 11 patients consented to the evaluation with a combined 107‐year history of recalcitrant leg ulcers. Although the pre‐geko™ healing rate was unknown, all ulcers were considered non‐healing. With geko™, the average weekly percentage reduction in surface area for all patients was 4·5% and for the six adherent to geko™ and best practices 7·0%. By comparison, the average weekly percentage reduction for measurable wounds in the five non‐adherent patients was 1·8%. Requirements for success appear to include an arterial status adequate for healing, effective and prompt management of wound infections and adherence to the treatment schedule. The geko™ device has been added to the medical supply formulary in one centre and is pending in the other.     

The effect of α-blocker therapy on erectile functions in patients with lower urinary tract symptoms due to benign prostate hyperplasia

In this study we aimed to evaluate the impact of doxazosin treatment on erectile functions in patients with lower urinary tract symptoms （LUTS） and having erectile dysfunction （ED） at baseline. Fifty-three patients with LUTS （IPSS score 〉 7） whose maximum flow rate （Qmax） 〈 15 mL s-1 and PSA 〈 4 ng dL^-1 were enrolled in the study. Patients received doxazosin 4 nag once daily for 6 weeks. Subjective efficacy was assessed by IPSS, IPSS- Quality of Life （IPSS-QoL） for LUTS and efficacy was assessed by International Index of Erectile Function （IIEF） for erectile functions at baseline and sixth weeks. The objective efficacy was assessed by Q The patients were classified according to their self reported erectile status： group I had ED and group II did not have ED. At the endpoint, doxazosin significantly improved the total IPSS score （-7.7 ±6.1, P = 0.006）, IPSS-QoL score （-1.5 ± 1.5, P = 0.024） and Qmax （3.2 ± 4.6 mL s^-1, P = 0.002） over baseline. Mean decrease in IPSS and IPSS-QoL scores after the treatment period were 6.9 ＋ 6.4 （P 〈 0.001） and 0.95 4- 1.80 （P 〈 0.05） in group I, whereas 8.2 4- 5.8 （P 〈 0.001） and 1.9 4- 1.1 in group IX （P 〈 0.001）, respectively. Mean changes of Qmax values were 2.3 4- 3.3 mL s^-1 in group I （P 〈 0.05） and 3.7 4- 5.3 mL s-1 in group II （P 〈 0.001）. The improvement of IIEF-EF scores after the treatment period was only significant for group I. The efficacy of a-blocker therapy for LUTS was better by means of symptomatic relief for patients who did not have ED when compared with patients who had ED at baseline. However, slight improvement in erectile functions with a-blocker therapy was only seen in LUTS patients with ED.