Split-thickness skin graft donor site management: a randomized controlled trial comparing polyurethane with calcium alginate dressings

Split‐thickness skin grafting (SSG) is a common reconstructive technique for the treatment of patients with deep burns and other traumatic injuries. The management of the donor site after harvesting an SSG remains controversial because of a variety of dressings available for use. The aim of this randomized controlled trial was to compare the effectiveness of a polyurethane dressing, Allevyn?, to a calcium alginate, Kaltostat®. From August 2009 to April 2010, 36 patients were randomized to Allevyn? or Kaltostat® for donor site management following split skin graft surgery. Pain intensity and adverse events were the primary outcomes assessed. Secondary outcome measures included time for wound healing, ease of application and removal and overall patient satisfaction. Time to first dressing change was earlier in those randomized to Allevyn? compared with Kaltostat® (5·5 days versus 8·11 days, P = 0·014). In patients randomized to Allevyn?, excessive exudate lead to a significantly increased number of dressing changes before day 10 (14 days versus 7 days, P = 0·018). The total number of dressing changes applied was also greater in those with Allevyn? compared with Kaltstat® (P = 0·007). There were no significant differences between the two treatment groups with respect to time to wound healing, level of pain intensity, length of stay, staff and patient satisfaction levels. This trial showed Allevyn? to be associated with increase demands on nursing time, increased cost of dressing products, medical consumables and wastes. Kaltostat® remains the dressing of choice for initial donor site dressing in this burns unit.     

Clinical trial of calcium alginate haemostatic swabs

The influence of a new haemostatic material on surgical bleeding was evaluated in 100 patients who were prospectively randomized to either normal surgical gauze or calcium alginate swabs used throughout cholecystectomy (n = 40), simple mastectomy (n = 18) or inguinal hernia repair (n = 42). Overall, median (range) blood loss was 91 (3-329) ml for gauze and was significantly reduced by calcium alginate swabs to 72 (2-181) ml (P less than 0.05). Unexpectedly, operation times were also shortened from 45 (17-95) min for gauze to 35 (13-70) min with calcium alginate swabs (P less than 0.02). This reduction in blood loss and operating time was greatest for mastectomy, was still statistically significant for cholecystectomy, but was unimportant in inguinal hernia repair. Calcium alginate haemostatic swabs may become routine in major surgery, particularly where blood loss leads to the need for transfusion.     

Effects of vitamin D and calcium supplementation on falls: a randomized controlled trial.

Specific receptors for vitamin D have been identified in human muscle tissue. Cross-sectional studies show that elderly persons with higher vitamin D serum levels have increased muscle strength and a lower number of falls. We hypothesized that vitamin D and calcium supplementation would improve musculoskeletal function and decrease falls. In a double-blind randomized controlled trial, we studied 122 elderly women (mean age, 85.3 years; range, 63-99 years) in long-stay geriatric care. Participants received 1200 mg calcium plus 800 IU cholecalciferol (Cal+D-group; n = 62) or 1200 mg calcium (Cal-group; n = 60) per day over a 12-week treatment period. The number of falls per person (0, 1, 2-5, 6-7, >7 falls) was compared between the treatment groups. In an intention to treat analysis, a Poisson regression model was used to compare falls after controlling for age, number of falls in a 6-week pretreatment period, and baseline 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D serum concentrations. Among fallers in the treatment period, crude excessive fall rate (treatment - pretreatment falls) was compared between treatment groups. Change in musculoskeletal function (summed score of knee flexor and extensor strength, grip strength, and the timed up&go test) was measured as a secondary outcome. Among subjects in the Cal+D-group, there were significant increases in median serum 25-hydroxyvitamin D (+71%) and 1,25-dihydroxyvitamin D (+8%). Before treatment, mean observed number of falls per person per week was 0.059 in the Cal+D-group and 0.056 in the Cal-group. In the 12-week treatment period, mean number of falls per person per week was 0.034 in the Cal+D-group and 0.076 in the Cal-group. After adjustment, Cal+D-treatment accounted for a 49% reduction of falls (95% CI, 14-71%; p < 0.01) based on the fall categories stated above. Among fallers of the treatment period, the crude average number of excessive falls was significantly higher in the Cal-group (p = 0.045). Musculoskeletal function improved significantly in the Cal+D-group (p = 0.0094). A single intervention with vitamin D plus calcium over a 3-month period reduced the risk of falling by 49% compared with calcium alone. Over this short-term intervention, recurrent fallers seem to benefit most by the treatment. The impact of vitamin D on falls might be explained by the observed improvement in musculoskeletal function.     

Music versus diazepam to reduce preoperative anxiety: a randomized controlled clinical trial

OBJECTIVES: To compare the effectiveness of music to that of diazepam in reducing preoperative anxiety. PATIENTS AND METHODS: Patients were randomized to 2 groups to receive diazepam or listen to music on the day of surgery and the previous day. Just before the operation, anxiety was assessed with the State-Trait Anxiety Inventory. Cortisol levels, heart rate, and blood pressure were also recorded. RESULTS: Two hundred seven patients were enrolled. No significant differences in any of the outcome measures (anxiety, cortisol level, heart rate, or blood pressure) were found between the 2 groups (music vs sedative). CONCLUSIONS: Our findings indicate that music is as effective as sedatives for reducing preoperative anxiety.     

Efficacy and safety of sclerotherapy using polidocanol foam: a controlled clinical trial.

OBJECTIVE: To assess the efficacy and safety of sclerotherapy performed with polidocanol foam compared to liquid polidocanol. METHODS: Controlled clinical trial with 1 year follow up in which each patient acted as his/her own control. A total of 75 patients (six men and 69 women) with reticular or postoperative varices were enrolled and sclerotherapy was performed with liquid and with foam (Tessari method) using the same quantity of sclerosant for homogeneous varicose regions, to a total of 150 procedures. The sclerosant concentration was adjusted according to the vein diameter as assess by ultrasonography. The foam group was given 50% lower concentrations of sclerosant than liquid sclerosant group. Clinical assessment (pain, inflammation, pigmentation) and ultrasound examination (diameter of the lumen and length of sclerosed vein) were carried out at 15, 30, 90, and 365 days. RESULTS: Foam allowed complete sclerosis at 90 days in 94.4% of patients compared with 53% for liquid (p<.001) and also allowed a more extensive venous sclerosis (10.1cm compared with 7.2 cm; p<.001). Pain, signs of inflammation, and pigmentation appeared more often with foam sclerosis, with significant difference. The degree of satisfaction was similar for both techniques. CONCLUSIONS: Efficacy of venous sclerosis with foam seems to be greater than with liquid although there is a higher risk of minor secondary effects.     

Regional specificity of exercise and calcium during skeletal growth in girls: a randomized controlled trial.

Combining exercise with calcium supplementation may produce additive or multiplicative effects at loaded sites; thus, we conducted a single blind, prospective, randomized controlled study in pre- and early-pubertal girls to test the following hypotheses. (1) At the loaded sites, exercise and calcium will produce greater benefits than exercise or calcium alone. (2) At non-loaded sites, exercise will have no benefit, whereas calcium with or without exercise will increase bone mass over that in exercise alone or no intervention. Sixty-six girls aged 8.8 +/- 0.1 years were randomly assigned to one of four study groups: moderate-impact exercise with or without calcium or low-impact exercise with or without calcium. All participants exercised for 20 minutes, three times a week and received Ca-fortified (434 +/- 19 mg/day) or non-fortified foods for 8.5 months. Analysis of covariance (ANCOVA) was used to determine interaction and main effects for exercise and calcium on bone mass after adjusting for baseline bone mineral content and growth in limb lengths. An exercise-calcium interaction was detected at the femur (7.1%, p < 0.05). In contrast, there was no exercise-calcium interaction detected at the tibia-fibula; however, there was a main effect of exercise: bone mineral content increased 3% more in the exercise than non-exercise groups (p < 0.05). Bone mineral content increased 2-4% more in the calcium-supplemented groups than the non-supplemented groups at the humerus (12.0% vs. 9.8%, respectively, p < 0.09) and radius-ulna (12.6% vs. 8.6%, respectively, p < 0.01). In conclusion, greater gains in bone mass at loaded sites may be achieved when short bouts of moderate exercise are combined with increased dietary calcium, the former conferring region-specific effects and the latter producing generalized effects.     

The haemostatic effect of purse-string suture in transvesical prostatectomy: a controlled clinical trial.

In a series of 64 consecutive cases of transvesical prostatectomies it is shown that the use of a purse-string suture at the bladder neck significantly reduces the postoperative blood loss. A follow-up 3 months after operation has shown that the suture did not increase the number of either bladder neck stenoses, urinary incontinences, urinary infections or secondary lithiases.     

Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial

Purpose

Prevention of parastomal hernia represents an important aim when a permanent stoma is necessary. The objective of this work is to assess whether implantation of a prophylactic prosthetic mesh during laparoscopic abdominoperineal resection contributed to reduce the incidence of parastomal hernia.

Methods

Rectal cancer patients undergoing elective laparoscopic abdominoperineal resection with permanent colostomy were randomized to placement of a large-pore lightweight mesh in the intraperitoneal/onlay position by the laparoscopic approach (study group) or to the control group (no mesh). Parastomal hernia was defined radiologically by a CT scan performed after 12 months of surgery. The usefulness of subcutaneous fat thickness measured by CT to discriminate patients at risk of parastomal hernia was assessed by ROC curve analysis.

Results

Thirty-six patients were randomized, 19 to the mesh group and 17 to the control group. Parastomal hernia was detected in 50?% of patients in the mesh group and in 93.8?% of patients in the control group (P?=?0.008). The AUC for thickness of the subcutaneous abdominal was 0.819 (P?=?0.004) and the optimal threshold 23?mm. Subcutaneous fat thickness ??23?mm was a significant predictor of parastomal hernia (odds ratio 15.7, P?=?0.010), whereas insertion of a mesh was a protective factor (odds ratio 0.06, P?=?0.031).

Conclusions

Use of prophylactic large-pore lightweight mesh in the intraperitoneal/onlay position by a purely laparoscopic approach reduced the incidence of parastomal hernia formation. Subcutaneous fat thickness ??23?mm measured by CT was an independent predictor of parastomal hernia.     

Hernia repair and local anesthesia. Results of a controlled randomized clinical trial

In the past, general and spinal anesthesia were used for hernia surgery, but nowadays local anesthesia has become the method of choice for hernia repair, especially in outpatient patients. The one-day surgery is sufficient in the management of this pathology. The advantages of local anesthesia are simplicity, safety, extended postoperative analgesia, early mobilization, lack post-anesthesia effects, and low costs. From January 2004 to December 2008 we observed 297 male patients with inguinal hernia. These patients were divided, with rigorous chronological order of hospital admission, in two study groups, different for anesthetic techniques used. Our controlled randomized clinical trial examines the effectiveness of local anesthesia to reduce the time of hospitalization, without alteration of results, and particularly the degree of satisfaction of patients surgical treated for inguinal hernia.     

Staples for wound closure: a controlled trial.

Skin staples were compared with two conventional suture methods for speed, convenience, effectiveness and cost. One hundred and ninety-five patients having linear abdominal incisions were randomly allocated to one of three methods of interrupted skin closure--polypropylene sutures, polyglactin sutures or stainless steel staples and the wounds were assessed over 30 days. The mean rate of wound closure using sutures was 4.2 cm per minute while staples were faster at 22.5 cm per minute and saved an average of three minutes per wound. The time saved was considerably greater with long incisions. Staples cost 50p more per 15 cm wound than either suture. In other respects the three methods were comparable except that polyglactin caused the least wound pain. We believe the advantages of speed and convenience of skin staples outweigh the extra cost, provided the disposable instruments are reused until empty.     

手法整复为主治疗腰椎间盘突出症临床对照试验

目的：探讨以手法整复为主的综合治疗对腰椎间盘突出症患者疼痛和临床疗效的影响。方法：选择1986年11月至2007年6月收治的腰椎间盘突出症11128例,分为对照组、治疗组。治疗组5760例,男2882例,女2878例;年龄13～86岁。对照组5368例,男2688例,女2680例;年龄20～85岁。对照组采用腰椎牵引和各种理疗进行治疗,治疗组在对照组治疗的基础上加用手法整复治疗。以上治疗每日1次,10次为1个疗程,3个疗程后进行疗效评定。结果：经疼痛视觉模拟评分法（VAS）评价,治疗组治疗后评分平均为（2.13±1.46）分,对照组平均为（4.65±2.14）分,两组比较,差异有统计学意义（P〈0.01）,具有可比性。对照组治愈率为47.28%,治疗组治愈率为73.44%,2组比较,治疗组优于对照组（P〈0.01）。结论：手法整复为主的方法治疗腰椎间盘突出症,能明显改善腰痛症状,提高临床疗效。     

静脉伊班膦酸钠冲击治疗类固醇性骨质疏松症的临床对照研究

目的评价伊班膦酸钠治疗类固醇性骨质疏松症的有效性和安全性。方法采用随机、对照研究。153例类固醇性骨质疏松症患者,随机分为埘照组(C组,49例)、伊班膦酸钠治疗组(Ⅰ组,52例)和阿法骨化醇治疗组(R组,52例)。3组患者均每天补充碳酸钙600mg/d。Ⅰ组:应用伊班膦酸钠注射液静脉点滴,3个月1次,每次2mg。R组:罗钙全0.25μg/d,口服。疗程6个月。观察伊班膦酸钠治疗后患者腰椎骨密度、股骨颈骨密度、全段甲状旁腺激素(iPTH)、血钙、血磷、血清碱性磷酸酶(AKP)等骨代谢指标的变化及不良反应发生情况。结果(1)治疗6个月后,Ⅰ组、R组腰椎及股骨颈骨密度均较C组明显上升[腰椎骨密度(g/cm2):Ⅰ组比C组,1.28±0.04比0.82±0.04,P<0.01;R组比C组,1.14±0.03比0.82±0.04,P<0.05;股骨颈骨密度(g/cm2):Ⅰ组比C组、1.29±0.04比0.90±0.04,P<0.05;R组比C组,1.21±0.06比0.90±0.04,P<0.05]。(2)治疗6个月后,Ⅰ组和R组血iPTH水平均较C组下降[Ⅰ组比C组,39.02±1.28比90.67±10.02(pg/ml),P<0.01;R组比C组,52.43±1.42比90.67±10.02(pg/ml),P<0.05]。(3)伊班膦酸钠治疗后,患者无严重不良反应发生。结论伊班膦酸钠是一种治疗类固醇性骨质疏松症的有效而安全的药物,其升高骨密度的作用比阿法骨化醇明显,且静脉应用患者依从     

Haemorrhoidectomy: randomised controlled clinical trial of Ligasure compared with Milligan-Morgan operation.

OBJECTIVE: To evaluate the efficacy of the Ligasure system in the management of haemorrhoids. DESIGN: Unblinded randomised clinical trial. SETTING: Teaching hospital, Spain. PATIENTS: 112 patients with third and fourth degree haemorrhoids. INTERVENTIONS: For 56 patients we used Ligasure system and a variant of Milligan and Morgan's technique. For the other 56, we used the traditional technique. MAIN OUTCOME MEASURES: Postoperative pain. RESULTS: Operating times varied from 100 seconds for each haemorrhoidal cushion with Ligasure system to the 313 seconds by the traditional technique. The blood loss was not quantifiable in patients operated on with Ligasure. Pain was scored on a visual analogue scale. In the Ligasure group, the mean scores were 4.9 (immediate postoperative period) and 2.3 (24 hours later). In the other group, the scores were 7.8 and 6.9. These differences were significant. CONCLUSION: Haemorrhoidectomy using Ligasure as a technical variant of Milligan and Morgan's technique has important advantages.