Triple-blind Randomized Clinical Trial Research Articles

Efficacy of a standardized herbal product from Pistacia atlantica subsp. Kurdica in type 2 diabetic patients with hyperlipidemia: A triple-blind randomized clinical trial

BackgroundHyperlipidemia is one of the consequences of type 2 diabetes mellitus (T2DM) that puts the patients at the risk of getting cardiovascular disease. Pistacia atlantica subsp. Kurdica is used by local people for the improvement of lipid and glucose indices. This study was carried out to evaluate clinical effects of P. atlantica subsp. Kurdica on hyperlipidemia related to T2DM patients. Materials and methodsIn this randomized, triple-blind, and placebo-controlled study, type 2 diabetes patients with hyperlipidemia were randomly allocated to receive either P. atlantica kurdica or placebo capsule for 2 months. 58 Patients were followed up at the beginning and after the end of each month for assessment of lipid profiles, glucose indices, and liver and renal function tests. The herbal capsule was standardized according to volatile and nonvolatile compounds by GC-MS/FID and RP-HPLC-PDA, respectively. The total phenolic and flavonoid contents were also determined with a spectrophotometer. ResultsAfter 1 and 2 months of the intervention period, mean differences of 2HPP, total cholesterol, and LDL-c have been reduced significantly (P < 0.05) between the two groups, but there were not reported any significant statistical changes in FBS, HbA1c, TG, HDL-c, ALT, AST, and Cr. The herbal capsule was standardized according to benzoic acid, ballic acid, rutin, and quercetin standard (6.5, 2.1, 1.4, 0.7 mg, respectively), and also α-pinene as major volatile constituent 28.51%. ConclusionAccording to results the P. atlantica kurdica is effective in the improvement of lipid profile and glucose indices in line with its local application. Clinical trial id(IRCT201708109014N178).

The effects of licorice mucoadhesive patches (Aftogel®) on the results of nasopharyngeal swab real-time PCR test of SARS-CoV-2: a randomized triple-blind placebo-controlled clinical trial

Background and objectives: Up to present no efficacious antiviral medications have been discovered in order to eradicate SARS-CoV-2 in nasopharyngeal tract. In this article, the aim is to evaluate the effectiveness of a new herbal drug product called Aftogel patch, which contains licorice extract, in the eradication of this novel coronavirus in the nasopharyngeal secretions of the patients. Methods: In this triple-blind randomized clinical trial, 125 patients with positive real-time PCR for SARS-CoV-2 and in stage 0 and/or 1 of COVID-19 were studied in two separate groups, namely interventional and placebo, in which they used Aftogel and placebo patches, respectively. At the end of the study, the results of PCR test in aforementioned groups were assessed and compared. Results: Following the application of Aftogel, Real-time PCR was converted to negative in 53.97% of patients which was significantly higher than that of the placebo groups. (27.40%, P= 0.003). Conclusion: It seems that Aftogel mucoadhesive patch (Licorice extract) is effective in the eradication of SARS-CoV-2 which has colonized the nasopharyngeal area. Hence, this drug product has the potential for evaluation as a prophylactic agent against COVID-19.

The effect of calcium and vitamin D supplements on blood pressure in postmenopausal women: myth or reality?

Hypertension is a highly prevalent disease with serious cardiovascular and renal complications. Many studies have demonstrated a weak correlation between the consumption of calcium (or calcium plus vitamin D) and blood pressure, suggesting that calcium supplements might reduce blood pressure. However, the results to date remain controversial. In this study, we assessed the effect of calcium and vitamin D supplementation on the blood pressure of postmenopausal women with hypertension as a population group in which the use of calcium supplements is prevalent. This triple-blind randomized clinical trial enrolled 98 women of postmenopausal age with hypertension in 2019. The study period was 8 weeks with close follow-up. We used 24-h ambulatory blood pressure monitoring to record the initial and final blood pressure in all participants. The changes in both the mean systolic (p = 0.047) and diastolic blood pressure (p = 0.015) were suggestive of an increase in blood pressure after consuming calcium and vitamin D supplements. Among patients who had been using calcium channel blockers, calcium and vitamin D supplementation caused a notable increase compared to baseline systolic (p = 0.019) and diastolic blood pressures (p = 0.001). The present results differ from those of previous studies. This suggests that calcium supplementation for postmenopausal women with hypertension requires the close observation of blood pressure to prevent any further increase, especially in women who are being treated with calcium channel blockers (clinicaltrial.gov registration: NCT04618952).

Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapy-induced nausea and vomiting: A triple-blinded randomized clinical trial

IntroductionThis study was performed to evaluate the degree of 3-day chemotherapy-induced nausea and vomiting (CINV) in children with cancer who received highly emetogenic chemotherapy (HEC) to ascertain the efficacy of aprepitant single-dose on dayL 1 plus granisetron and dexamethasone (DEX). MethodsThis clinical trial study was conducted on 120 patients in the age range of 5 to 18 years old who received chemotherapy. Patients were divided into two groups; Group A received aprepitant at 125 mg/kg on day 1 orally, followed by 80 mg/kg daily on days 2 and 3 and Group B received a single dose of aprepitant 125 mg/kg on day 1 orally and placebo on days 2 and 3. All groups received granisetron 3 mg/m2 on day 1 and DEX on days 1 to 3. The primary and secondary endpoints were to evaluate the proportion of patients with acute, delayed and overall CINV within each group. ResultsThere were no significant differences between the two groups for vomiting, nausea or the use of rescue therapy. The number of patients without vomiting on day 1 was similar in both groups (96.5% vs. 98.3%, respectively; p = 0.848). ConclusionAccording to the results of this study, a single dose of aprepitant 125 mg/kg was as effective as administering three doses of aprepitant on 3 days. Therefore, the use of a single dose of aprepitant in combination with other standard treatment regimens to prevent CINV in children who received HEC was safe and efficacious and can be beneficial.

Evaluating the Preemptive Analgesic Effect of Photo-biomodulation Therapy on Pain Perception During Local Anesthesia Injection in Children: A Split-mouth Triple-blind Randomized Controlled Clinical Trial.

To evaluate the impact of photobiomodulation therapy (PBMT) on injection pain perception and compare it with a topical oral anesthetic gel. A total of 30 patients of 6 to 9years-old seeking pulpotomy treatment of maxillary secondary primary molars of both sides were considered for this split-mouth triple-blind randomized clinical trial. On one side of the maxilla, the low-level laser (diode laser, 808 nm, 250 mW; 16.25 J; 32.5 J cm-2 ) was irradiated upon the buccal gingiva of the tooth, while a Benzocaine 20% topical anesthetic gel was applied on the other side. A gel with the same taste (strawberry) was applied for the placebo. The Wong-Baker Faces Pain Rating Scale was used to evaluate the injection pain and postoperation pain at two timestamps, 1 h and 24 h after treatment. Patients' heart rate was also evaluated. Paired t, Wilcoxon signed-rank test, McNemar and Friedman tests were used for statistical analyses. Results demonstrated that PBMT could significantly decrease the injection pain perception and heart rate alternations compared to the topical anesthetic gels (P = 0.000). However, no significant differences were documented between the two methods concerning the 1-h (P = 0.26) and 24-h (P = 1.00) postoperation pain. PBMT can be an effective nonpharmacological technique for controlling injection pain.

Efficacy of HAF toothpastes in primary and permanent dentitions. A 2-years triple-blind RCT

ObjectivesThe aim of this RCT was to compare the caries preventive efficacy and the slowing down of previous caries lesions of toothpastes containing fluoride biomimetic hydroxyapatite (HA) complex compared to sodium monofluorophosphate fluoridated toothpastes in Italian schoolchildren. To validate this hypothesis a triple-blind randomized clinical trial was designed. MethodsIn total 610 children (4–5 and 6–7 years) were enrolled. Four toothpastes, two containing fluoride-substituted hydroxyapatite (HAF) (1000 and 1450 ppmF) and magnesium-, strontium-, carbonate-substituted hydroxyapatite, in a chitosan matrix and two Mono fluoridated toothpastes (1000 and 1450 ppmF) were randomly administered during 24 months to two groups with younger children (Gyoung) and to two groups with older children (Gold), those containing 1450 ppmF. ICDAS was used to score lesions as initial (up to score 2), moderate (scores 3–4) and severe (scores 5–6). The children were instructed to brush for two minutes three times/day. Caries examination was repeated at 12 and 24 months. The efficacy of the treatment was assessed by calculating the reduction in Risk Ratio (RR) and the number needed to treat (NNT). Results; Overall, 518 patients (Gyoung = 268; Gold = 250) concluded the trial. The drop-rate was 11.84% for Gyoung and 17.22% for Gold. The caries increment at 24-month evaluation was statistically lower in the primary dentition in the HAF arms compared to the traditional fluoridated arms (0.18 vs 0.27 p = 0.04 in Gyoung and 0.16 vs 0.30 p = 0.01 in Gold for severe lesions). In the permanent dentition (Gold), caries increase was also statistically lower in the HAF arm, both for initial and severe lesions (0.09 vs 0.17 p = 0.02 and 0.18 vs 0.28 p = 0.01, respectively). In primary dentition, children receiving HAF Toothpaste had a RR of 39% (Gyoung) and 38% (Gold), compared to children receiving traditional Toothpastes. The RR in the permanent dentition was 29% in children treated with HAF toothpaste. Conclusions; The use of toothpastes containing biomimetic hydroxyapatite and fluoride reduces caries increment in children over a period of 2 years more than traditional fluoridated toothpastes.

Preemptive analgesia with ibuprofen increases anesthetic efficacy in children with severe molar: a triple-blind randomized clinical trial

Molar incisor hypomineralization (MIH) is often accompanied by dental hypersensitivity and difficulty in achieving effective analgesia.Objective:This study evaluated the effectiveness of preemptive analgesia in children with severe MIH, post-eruptive enamel breakdown, and hypersensitivity.Methodology:Ibuprofen (10 mg/kg child weight) or placebo was administered, followed by infiltrative anesthesia and restoration with resin composite. Hypersensitivity was evaluated in five moments. The data were analyzed using the chi-square test, Fisher’s exact test, and t-test.Results:Preemptive analgesia provided benefits for the treatment of severe cases of MIH, with an increase in the effectiveness of infiltrative anesthesia and improved patient comfort during the restorative procedure.Conclusion:Preemptive analgesia has shown efficacy in reducing hypersensitivity during restorative dental procedures, evidencing the significance of this study for patients with MIH and hypersensitivity.

Efficacy of intraoperative epidural dexamethasone and bupivacaine in reduction of pain and disability following lumbar discectomy.

ABSTRACTBackground:In lumbar disc herniation, although surgery can provide relief from pain in the low back and lower extremities, many drugs can provide more relief; thus, the aim was the evaluation of epidural dexamethasone and bupivacaine efficacy in lumbar disc herniation surgery.Methods:A total of 42 cases were evaluated in a triple-blind randomized clinical trial study. Patients were divided into intervention and control groups based on permuted block randomization. The patient’s condition was assessed based on the Visual Analogue Scale (VAS) at 3, 6, 12, and 24 h and 1, 3, and 6 months after surgery. In addition, the patient’s disability was assessed by Oswestry disability index (ODI) at 1 and 6 months after surgery.Results:Of the 42 evaluated cases, age (44.0 ± 12.4, P = 0.4) and hospitalization duration (1.9 ± 0.3 days, P = 0.02) had statistically significant difference between two groups. The severity of low back pain before surgery was 2.9 ± 1.9 (P = 0.74), and 3 hours after surgery was 4.9 ± 1.9 in the control group and 2.8 ± 1.3 in the intervention group (P = 0.03), and there was a statistically significant difference between the two groups. In addition, based on the repeated measure test, there was no significant difference between the two groups. ODI value was before surgery 31.7 ± 8.3 (P = 0.77), 5.2 ± 2.4 (P = 0.9) at 1 month after surgery, and 4.5 ± 1.8 (P = 0.6) at 6 months after surgery, and there was no statistically significant difference between the two groups.Conclusion:Dexamethasone and bupivacaine can be effective in post-operation pain control, although this difference between the two groups was not statistically significant.

The effect of medicinal syrup made from silkworm cocoon on mixed anxiety-depression disorder: a triple-blind randomized clinical trial

Objective: Silkworm cocoon produced by silkworms with the scientific name of Bombyx mori L. is a well-known medicinal agent mainly composed of proteins. This study was designed to assess the efficacy of syrup made from this natural agent on mild to moderate depression. Design: The study was designed as a triple blind randomized clinical trial (RCT). Sixty patients with mixed anxiety–depressive disorder (MADD) were randomized to receive either intervention (silk syrup plus sertraline) or control (placebo syrup + sertraline) for a period of 12 weeks. Depression and anxiety were assessed by using the Beck depression and anxiety inventories at weeks 0, 6 and 12. Results: Fifty-four patients completed the trial in two groups of intervention (n = 30) and control (n = 24) and entered final analysis. According to the results of this study, the mean of anxiety and depression in weeks 6 and week 12 in the intervention group was significantly lower than the control group (p&lt;0.001). Conclusion: Silk syrup can be beneficial for management of anxiety and depression in mild to moderate MADD. Thus, it is suggested as an adjuvant treatment to increase efficacy of conventional drugs in MADD patients.

A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions

The aim of this study is to evaluate the preemptive analgesic effects of dexamethasone (DEX) alone or combined with non-steroidal anti-inflammatory drugs (NSAIDs) in third molar surgeries. The subjects were divided into five groups (n = 20 teeth/group); subjects received only 8 mg of dexamethasone 1 h before the surgical procedure (DEX group), or in combination with etodolac (DEX + ETO), ketorolac (DEX + KET), ibuprofen (DEX + IBU), loxoprofen (DEX + LOX). Paracetamol 750 mg was provided as the number of rescue analgesics (NRA). Salivary PGE2 expression was measured preoperatively and at 48 h. Edema and Maximum mouth opening (MMO) were measured postoperatively at 48 h and 7 days. A visual analog scale (VAS) was performed postoperatively at 6, 12, 24, 48, 72 h, and 7 days. Salivary expression of PGE2 showed a decrease only for the DEX group. Edema and MMO and NRA consumption showed no significant differences among the groups (P > 0.05). The VAS showed a significantly lower pain perception at 6 h after the surgery for the DEX + ETO and DEX + KET groups (P < 0.05). The combination of DEX and NSAIDS should be considered for preemptive acute postsurgical pain management in third molar surgery. In some drug associations such as dexamethasone 8 mg + NSAIDS (ETO and KET) in the pre-operative time, only a few rescue analgesics are necessary.

Effect of Dexmedetomidine infusion during hip fracture surgery on hemodynamic parameters and blood loss: A triple-blinded Randomized Clinical Trial

Introduction In this study, we aim to assess the intra-operative effect of dexmedetomidine administration on the hemodynamic parameters and bleeding volume during hip fracture surgery.Patients and methods we designed and implemented a triple-blinded randomized clinical trial to objectively compare the effects of 0.5 µg/kg/h infusion of dexmedetomidine with placebo (equal amount of normal saline) during hip fracture surgery. All included cases were between 30 and 70 years old and underwent surgery for fixation of a proximal femur fracture from September 26, 2020 until February 15, 2021. They were all ASA class I or II with preoperative hemoglobin levels of 10 mg/dL or higher. Surgical blood loss and hemodynamic parameters were documented.Results 76 patients were enrolled. There were no significant differences in baseline patient characteristics. The bleeding rate was 620 ± 190.0 mL for the normal saline group and 476 ± 177.98 mL in the dexmedetomidine group (P = 0.04). No significant effect on hemodynamic parameters was observed.Conclusion Based on the current study, intravenous infusion of dexmedetomidine during hip fracture surgery under general anesthesia reduced the amount of intraoperative bleeding without causing any significant hemodynamic disturbances.Registration number IRCT20191222045857N1 (Iranian Registry of Clinical Trials)

The Effect of Vitex and Salvia Officinalis Extract on Some Osteogenic Factors in Postmenopausal Women: A triple-blind randomized clinical trial

The Effect of Vitex and Salvia Officinalis Extract on Some Osteogenic Factors in Postmenopausal Women: A triple-blind randomized clinical trial

The Effect of A New Mixture of Sugar and Sugar-Alcohol (Lacritose) on Blood Glucose and Lipids and the Possible Adverse Reactions in Patients with Type 2 Diabetes: A Triple-Blind Randomized Clinical Trial

Background: A new sweetener with the commercial name of Lacritose has been recently produced, which is a combination of four simple sugars (lactose, fructose, sucrose, erythritol), with specific ingredients and percentages. This study aimed to assess glycemic response and short term gastrointestinal reactions in type 2 diabetic patients.&#x0D; Methods: In this triple-blind randomized clinical trial, 30 diabetic patients referred to Yazd Diabetes Research Center in 2018 were included. After collecting the primary data, they were assigned into three groups, including sucrose consumers as the control group, sucrose-lactose, and lacritose as the groups of consumers group. They were followed for two weeks, and fasting blood glucose (FBG), 2-hour postprandial test (2HPP), fructose amine, SGOT, SGPT, urea, creatinine, and insulin resistance index (HOMA-IR) were assessed.&#x0D; Results: In lacritose consumers, significant reductions were seen in FBG and 2HPP (P &lt; 0.001 and P = 0.05, respectively), although changes among the groups were not significant. In sucrose-lacritose consumers, FBG and cholesterol levels decreased (P = 0.04 and P = 0.03, respectively). In sucrose consumers, no reduction was seen. HOMA-IR did not significantly decrease, but intergroup changes were obvious.&#x0D; Conclusion: The lacritose effects on FBG and 2HPP were significantly evident, but the other metabolic indices did not show any significant change.

A randomized clinical trial on therapeutic effects of 0.25 mg oral minoxidil tablets on treatment of female pattern hair loss.

Topical minoxidil solution is recommended treatment for female pattern hair loss. However, some complications, such as skin allergies, have prevented some patients from completely receiving this treatment. This study intends to evaluate the therapeutic and side effects of oral minoxidil 0.25 mg tablets treatment on FPHL and compare it with conventional treatment of 2% topical minoxidil. This study is a triple-blind randomized clinical trial in which 72 women with FPHL were treated as two separate groups. Group 1 was treated with oral minoxidil 0.25 mg tablets and topical placebo solution, while topical minoxidil solutions and oral placebo tablets were used to treat group 2 patients. In the oral minoxidil group, the average hair diameter and hair density after the 9-month treatment reached from 0.044 mm and 102 per cm2 to 0.048 mm and 115 per cm2 , respectively. In the topical minoxidil group, the average hair diameter and hair density from initial values of 0.044 mm and 107 per cm2 increased to 0.047 mm and 113 per cm2 . In both groups, the changes of hair diameter and hair density were significant compared to initial values (p <0.001), while the trend of changes was not statically different between the two groups (p =0.077, p =0.674 for hair diameter and hair density, respectively) and side effects were trivial. In conclusion, oral minoxidil is an effective and new treatment for FPHL, even with a minimal dose, which can be used as an alternative treatment, especially for patients with poor compliance against topical minoxidil.

Antihypertensive and antihyperlipemic of spirulina (Arthrospira platensis) sauce on patients with hypertension: A randomized triple-blind placebo-controlled clinical trial.

Systemic arterial hypertension is an independent risk factor for coronary heart disease, stroke, heart failure, and chronic kidney diseases. Spirulina is microalgae with nutritious ingredients and has potential attenuating effects on chronic diseases including hypertension. Spirulina can be added to food products in order to develop functional foods. The aim of this study was to assess the effects of 8-week consumption of a salad dressing containing 2 g of spirulina platensis powder versus a placebo dressing on patients with hypertension. In this triple-blind randomized clinical trial, 48 patients with hypertension were enrolled to receive daily either spirulina-fortified dressing or placebo for 2 months. A total of 41 patients completed this study. We observed that the consumption of spirulina dressing significantly reduced systolic blood pressure (p= .02), diastolic blood pressure (p= .03), serum triglyceride (p= .01), total cholesterol, and low-density lipoprotein (LDL) levels, compared to nonsignificant changes in the placebo group. Significant changes in TAC and hs-CRP levels were observed in none of the groups. According to our findings, spirulina-fortified dressing as a functional food can be used a supportive treatment for patients with hypertension along with standard antihypertensive drugs. However, further investigations are required for a more comprehensive conclusion.

The Antimicrobial Effect of Pomegranate Peel Extract versus Chlorhexidine in High Caries Risk Individuals Using Quantitative Real-Time Polymerase Chain Reaction: A Randomized Triple-Blind Controlled Clinical Trial.

The aim of the present study was to compare the antibacterial effectiveness of chlorhexidine and PPE oral rinse on S. mutans, Lactobacilli, and Veillonella, in clinical salivary samples of patients with advanced stages of dental caries at baseline and two and four weeks with PCR technique. This triple-blind randomized clinical trial involved 60 high caries risk adult patients, 19–59 years of age, randomly allocated into two groups of 30 subjects each. The intervention group received pomegranate peel extract mouthwash, whereas the control group received chlorhexidine mouthwash. Unstimulated pooled saliva was collected from the floor of the mouth before and after the intervention. The quantitative real-time polymerase chain reaction was employed to analyze the bacterial copies of each salivary sample at baseline and two and four weeks. The significance level was fixed at 5% (α = 0.05). Overall comparison of antimicrobial effectiveness across both groups revealed insignificant outcomes. The control group evinced a significant reduction in S. mutans between a specific time, i.e., baseline and 4 weeks (p=0.043). PPE oral rinse as a natural product or ecological alternative was effective in disrupting activity across all microorganisms tested in this triple-blind RCT; however, the nutraceutical, when compared to chlorhexidine, was not as effective against S. mutans.

What Is the Effect of Pre-Emptive Oral Montelukast on Postoperative Pain Following Bimaxillary Orthognathic Surgery? A Triple-Blind Randomized Clinical Trial

The aim of this study was to assess the effect of preoperative administration of oral montelukast on the amount of postoperative pain following bimaxillary orthognathic surgery. All healthy skeletal class III deformity candidates for bimaxillary orthognathic surgery were included in this triple-blind randomized clinical trial. The subjects were randomly divided into placebo and montelukast groups. One hour before the surgery, a 10 mL of apple juice was given to each and every patient; however, a 10 mg tablet of montelukast was dissolved in the juice for the intervention group. All operations were performed by the same surgical team, under the same general anesthesia protocols. The outcome variable was the amount of postoperative pain (1-, 3-, 6-, 12-, 18-, and 24-hour intervals) which was measured during the first 24 hours using a Visual Analog Scale. For statistical analysis, the significance level was set at 0.05 using SPSS 23. A total of 60 consecutive patients, comprising 31 females (51.7%) and 29 males (48.3%) with an average age of 25.2 ± 2.2 were recruited. The average surgical duration was 193 ± 28.0 minutes. In general, pain intensity exhibited an increasing trend from the first hour postoperatively, reaching its peak in the 12th hour and decreasing thereafter. Nevertheless, the average amount of pain was significantly higher in the placebo group compared with the montelukast group, in all the studied time intervals (P < .05). The number of patients who required postoperative opioid analgesics was significantly higher in the placebo group compared to the montelukast group (P=.024). Moreover, the duration of surgery had a direct and significant effect on the postoperative pain intensity (P < .001). It might be concluded that preoperative administration of montelukast is effective in reducing postoperative pain following bimaxillary orthognathic surgery. Further studies are necessary for more relevancy.

Role of artificial tears with and without hyaluronic acid in controlling ocular discomfort following PRK: a randomized clinical trial

To compare outcomes of applying preservative free artificial tears (PFAT) with and without hyaluronic acid (HA) in early postoperative course following photorefractive keratectomy (PRK). In this triple-blinded randomized clinical trial, PRK procedure was performed on both eyes of 230 patients. Following PRK, patients were divided into three groups: the HA+ group, 44 patients PFAT containing HA; the HA- group, 71 patients PFAT without HA were administered 5 times per day (every 4h); the third group, 115 patients received no PFAT before lens removal. On the 1st and 4th postoperative day, Visual Analogue Score (VAS) was utilized to evaluate patient's level of pain. Participants were asked to complete a questionnaire about the severity of eye discomfort ranked from 0 to 10 (0=no complaint; 10=most severe complaint experienced). In eyes receiving PFAT with or without HA (Drop group), mean scores for epiphora, foreign body sensation, and blurred vision on the 1st postoperative day were statistically lower (P<0.05). Filamentous keratitis (FK) was detected in 11 (4.7%) eyes, and recurrent corneal erosion (RCE) was observed in 5 (2.1%) eyes. In the control group, FK was noted in 16 (6.9%) eyes while 13 (5.6%) eyes had RCE and 5 (2.1%) eyes had corneal haze. The rate of complications was statistically lower in Drop group (P=0.009). However, the aforementioned scores were not statically different between HA+ and HA- group one and two (P=0.29). Following PRK, applying PFAT with and without HA yields faster visual recovery, decreases postoperative ocular discomfort and haze formation; however there is no additive effect for HA.

The effectiveness of prophylactic antibiotic prescribing (preventive) before cesarean section and prescribing after umbilical cord clamping in the infection after cesarean section: a triple-blind randomized clinical trial

مقدمه: سزارین یکی از شایع‌ترین اعمال جراحی در مامایی است. با توجه به نبودن رویکرد هماهنگ جهت تزریق آنتی‌بیوتیک قبل از سزارین و نامشخص بودن مزایا و معایب زمان تزریق آنتی‌بیوتیک بر روی مادر و جنین، لذا مطالعه حاضر با هدف مقایسه میزان اثربخشی تجویز آنتی‌بیوتیک پروفلاکتیک قبل از برش جراحی سزارین با تجویز بعد از کلامپ بند ناف، در پیشگیری از عفونت پس از سزارین انجام شد. روش‌کار: این مطالعه کارآزمایی بالینی تصادفی شده سه‌سو‌کور در سال 1398 بر روی 150 نفر از زنان با زایمان سزارین در بیمارستان شهیدان مبینی سبزوار انجام شد. در گروه مداخله، آنتی‌بیوتیک بعد از کلامپ بند ناف و در گروه کنترل آنتی‌بیوتیک قبل از برش سزارین تجویز شد. علائم عفونت با استفاده از چک‌لیست در روز سوم، دهم و چهاردهم مورد بررسی قرار گرفت. تجزیه و تحلیل داده‌ها با استفاده از نرم‌افزار آماری SPSS (نسخه 19) و آزمون‌های کای اسکوئر، تست دقیق فیشر و من‌ویتنی انجام شد. میزان p کمتر از 05/0 معنی‌دار در نظر گرفته شد. یافته‌ها: در روز سوم بعد از عمل جراحی هیچ‌کدام از بیماران دو گروه دچار عفونت نشدند. در روز دهم، ۱ نفر (3/1%) از گروه مداخله و 3 نفر (4%) از گروه کنترل دچار علائم عفونت شدند (31/0=p). در روز ۱۴ بعد از عمل، ۱ نفر (3/1%) از گروه کنترل و ۵ نفر از گروه مداخله (7/6%) علائم عفونت داشتند (10/0=p). اختلاف میزان عفونت در روز دهم و چهاردهم در دو گروه از نظر آماری معنادار نبود. نتیجه‌گیری: تزریق آنتی‌بیوتیک بعد از کلامپ بند ناف با یک‌ساعت قبل از شروع جراحی، تفاوتی در میزان عفونت بعد از عمل ندارد.

Platelet-Rich Plasma: Optimal Use in Surgical Wounds

Activated platelets release a rich broth of growth factors involved in wound healing. One way to deliver activated platelets to wounds is in the form of platelet-rich plasma (PRP) harvested by centrifuging the patient's venous blood after activating the platelets with collagen or calcium chloride and/or autologous thrombin, then delicately removing the supernatant, called platelet-poor plasma (PPP). Platelet-rich plasma is usually injected into the lesion and/or applied topically, then sealed in or over the wound using a moisture-retentive dressing. Platelet-rich plasma (often with PPP) has been applied at different times, depths, and frequencies to chronic and acute wounds using various PRP doses and vehicles to achieve widely differing results. Meta-analyses have reported that PRP improved healing rates of open diabetic foot ulcers and venous ulcers and may reduce pain and surgical site infection (SSI) incidence in open and closed acute surgical wounds. However, inconsistency in study methods and outcome measures limited consistency of pain and SSI results. No consistent effect on healing or deep SSI rates was reported as a result of adding 1 intraoperative dose of PRP in the surgical site before closing elective foot and ankle surgery incisions of 250 patients as compared with 250 similar patients receiving the same procedure without PRP. After decades of research, ideal parameters of PRP delivery and use on each type of wound remain unclear for improving SSI, acute wound pain, and healing outcomes. This installment of the Evidence Corner reviews 2 surgical studies that may provide clues about optimal PRP use. One triple-blind randomized clinical trial (RCT) focused on irrigation of freshly closed carpal ligament surgical incisions with PRP as compared with PPP. Another non-blind RCT explored the effect of injecting PRP into open pilonidal sinus excisions 4 days and 12 days after surgery.