Clinical evaluation of the treatment of multiple gingival recessions with connective tissue graft or concentrated growth factor using tunnel technique: a randomized controlled clinical trial
Clinical oral investigations. 2021
OBJECTIVE To assess the effectiveness of the combination of tunnel technique (TT) and concentrated growth factor (CGF) for root coverage in treating multiple gingival recessions (GR) and compare with the connective tissue graft (CTG). MATERIALS AND METHODS Forty patients with Miller Class I and II maxillary or mandibular GR were randomly divided into two groups as follows: TT + CTG and TT + CGF. The results at baseline and 6 months were evaluated for the following clinical parameters: complete root coverage (CRC), mean root coverage (MRC), gingival thickness (GT), gingival recession width (RW), gingival recession depth (RD), and keratinized tissue width (KTW). RESULTS At 6 months, a statistically significant difference was found in RD, RW, MRC, CRC, KTW, and GT compared with the baseline (p < 0.05). MRC was determined 89.52±16.36% in the TT + CTG and 76.60±24.10% in the TT + CGF (p < 0.05). CRC was achieved in 66.7% of the TT + CTG and 47.4% of the TT + CGF (p < 0.05). The increase in KTW and GT was significantly better in the TT + CTG group compared to the TT + CGF (p < 0.05). CONCLUSIONS The study showed that TT + CGF did not improve the results as much as TT + CTG in the treatment of Miller Class I and II GR. However, this finding is not sufficient to advocate the true clinical effects of CGF on GR treatment with TT. CLINICAL RELEVANCE CGF could not serve as a direct alternative biomaterial to the gold standard CTG. TRIAL REGISTRATION ClinicalTrials.gov Identification Number: NCT04561947.
Intravenous iron supplementation after liver surgery: Impact on anemia, iron, and hepcidin levels-a randomized controlled trial
BACKGROUND Anemia is a recognized risk factor for perioperative related morbidity and mortality and is frequently reported in liver surgeries with an estimated incidence of 32%. We aim to assess the impact of intravenous iron administration in the immediate postoperative period on anemia and iron status as well as to determine the kinetics of hepcidin after liver surgery. METHODS The HepciFer trial, a randomized controlled trial, included 50 patients undergoing liver surgery. In accordance with the randomization process, patients received either ferric carboxymaltose (15 mg/kg, maximum 1 g) or placebo 4 hours after surgery. RESULTS The mean hemoglobin level, 7 days after surgery, did not differ significantly between the intervention and control group (11.1 ± 1.8 g/dL and 10.4 ± 1.6 g/dL, respectively) with a mean difference of +0.7 g/dL ([95% confidence interval, -0.3 to +1.7], P = .173). Within patients receiving intravenous iron supplementation, none presented biological signs of functional iron deficiency. Hepcidin levels remained significantly higher during the observation period in the intervention group. Inflammatory biomarkers, red blood cells transfusion rate and hospital duration of stay were similar between groups. CONCLUSION Intravenous ferric carboxymaltose administration did not result in a significant increase of hemoglobin levels 7 days after surgery. However, this study suggests that intravenous iron supplementation in the immediate postoperative settings prevents functional iron deficiency. Intravenous iron supplementation overcame the hepcidin-mediated blockade of iron absorption and should be considered as the preferred route of administration in the postoperative period.
Safety and Efficacy of Intravenous Ferric Derisomaltose Compared to Iron Sucrose for Iron Deficiency Anemia in Patients with Chronic Kidney Disease With and Without Heart Failure
The American journal of cardiology. 2021
Ferric derisomaltose (FDI) is an intravenous (IV) high-dose iron formulation approved in the US for the treatment of iron deficiency anemia in adults who are intolerant of/have had an unsatisfactory response to oral iron, or who have non-dialysis-dependent chronic kidney disease (NDD-CKD). FERWON-NEPHRO was a randomized, open-label, multicenter clinical trial evaluating the safety and efficacy of a single infusion of FDI 1,000 mg versus up to 5 doses of iron sucrose (IS) 200 mg (recommended cumulative dose, 1,000 mg) over 8 weeks in patients with NDD-CKD and iron deficiency anemia. Of 1,525 patients included in the safety analysis, 244 (16%) had a history of heart failure (HF). Overall, the rate of serious or severe hypersensitivity reactions was low and did not differ between treatment groups. Cardiovascular adverse events (AEs) were reported for 9.4% of patients who had HF and 4.2% who did not. Time to first cardiovascular AE was longer following administration of FDI compared with IS (hazard ratio: 0.59 [95% CI: 0.37, 0.92]; p=0.0185), a difference that was similar in patients with or without HF (p=0.908 for interaction). Patients achieved a faster hematological response (assessed by changes in hemoglobin and ferritin concentrations, and increase in transferrin saturation) with FDI versus IS. In conclusion, in patients with NDD-CKD, a single infusion of FDI was safe, well tolerated, and was associated with fewer cardiovascular AEs and a faster hematological response, compared to multiple doses of IS. These effects were similar for patients with and without HF.
Effect of 4DryField® PH on blood loss in hip bipolar hemiarthroplasty following intracapsular femoral neck fracture - a randomized clinical trial
BMC musculoskeletal disorders. 2021;22(1):113
BACKGROUND One of the most common complications of hip arthroplasty is excessive blood loss that could necessitate allogenic blood transfusion, which is further associated with other complications, such as infections, transfusion reactions or immunomodulation. In gynecology, 4DryField®PH, an absorbable polysaccharide-based formulation, is used for hemostasis and adhesion prophylaxis. In this study, we evaluated its hemostatic effect in patients undergoing hip bipolar hemiarthroplasty following intracapsular femoral neck fracture. METHODS We studied 40 patients with intracapsular femoral neck fractures (Garden III or IV) admitted at our institution between July 2016 and November 2017. We included patients above 60 years with simple fracture and without pathologic fractures. Patients were randomized into intervention and control groups. The intervention group received 5 g of 4DryField® PH (subfascially and subcutaneously) during wound closure. Three drainages were inserted in a standardized manner (submuscular, subfascial, and subcutaneous) and drainage volume was measured immediately before extraction. Total blood loss was calculated using Mercuriali's formula and standard hemograms upon admission and five days after surgery. Volume of postoperative hematoma was measured using point-of-care ultrasound seven days after surgery. RESULTS Volume of the postoperative hematoma was reduced by 43.0 mL. However, significant reduction of total blood loss and drainage volume was not observed. CONCLUSIONS We observed that 4DryField® PH had a local hemostatic effect, thereby reducing volume of the postoperative hematoma. However, this reduction was small and had no effect on the total blood loss. Further studies are warranted to improve the application algorithm. TRIAL REGISTRATION DRKS, DRKS00017452 , Registered 11 June 2019 - Retrospectively registered.
Efficacy of Platelet-Rich Plasma in Enhancing the Osteogenic Potential of Bone Graft in Oral and Maxillofacial Region
Journal of maxillofacial and oral surgery. 2021;20(2):282-295
BACKGROUND Platelet-rich plasma (PRP) has been a breakthrough in the stimulation and acceleration of bone and soft tissue healing. It represents a relatively new biotechnology that is part of the growing interest in tissue engineering and cellular therapy. METHODS A prospective study was carried out in 50 patients. The cases were selected randomly in the age group of 8-50 years who needed bone grafts for alveolar cleft defects and surgical defects following removal of osteolytic jaw lesions. They were divided into study group with autologous PRP and control group without PRP. Bone density was calculated as per Hounsfield scale preoperatively and post-operatively for both the groups. RESULTS There was significant difference in the Hounsfield units at 06 months and 12 months post-operatively in both the groups showing good amount of bone regeneration. The preoperative volume of the defect and the post-operative volume of the regenerated bone were statistically analysed. The mean V2 was 0.7652 cc for the study group, whereas for control group, it was 0.4840 cc. The volume ratio for study group was 0.9070 and for control group was 0.6740. This showed greater bone regeneration in the study group. The results were statistically significant for both the groups. CONCLUSION PRP is a new application of tissue engineering and a developing area of interest for clinicians and researchers. It is a storage vehicle for growth factors, especially PDGF and TGF-b, both of which influence bone regeneration, and also eliminates the concerns about immunogenic reactions and disease transmission. PRP does enhance the healing of bone grafts in the maxillofacial region as shown by the increase in the density of bone.
Effect of Platelet-Rich Plasma on Bone Healing in Immediate Implants Analyzed by Cone Beam Computerized Tomography: A Randomized Controlled Trial
BioMed research international. 2021;2021:6685991
The possibility of platelet-rich plasma (PRP) on the improvement of bone and adjacent tissue recovery has previously been validated. However, there is insufficient data supporting the use of platelet-rich plasma to improve the healing of bone and adjacent tissues around an implant in the oral cavity. The purpose of this randomized controlled trial was to observe the effect of platelet-rich plasma (PRP) concentrate on marginal bone loss and bone density around immediate implant placement using Cone Beam Computerized Tomography (CBCT). This clinical study was conducted over a period of six months on 12 subjects, who were equally categorized into two groups. Group I was the control, whereas the subjects in Group II received PRP therapy at the surgical site. All subjects were given a standard treatment with a single implant system (DIO UFII hybrid sandblasted acid-etched implants). Inserted implants were analyzed through CBCT, and records were registered at baseline, at the 12(th) week before functional loading and the 26(th) week after functional loading. The bone loss was calculated at the proximal (mesial and distal) side of the implant and bone density at baseline, 12(th) week, and 26(th) week after implant placement. SPSS version 23.0 was used for statistical analysis of data. The changes in bone levels were measured and compared between the two groups using the Mann-Whitney U test, with no significant difference. Bone density was analyzed by an independent sample t-test, p value ≤ 0.05 was considered statistically significant. Again, no significant difference in bone density was observed between both groups at all three instances. Therefore, it can be concluded that local injection of PRP after immediate implant placement did not show any decrease in marginal bone loss or improvement in bone density. This trial is registered with NCT04650763.
Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial
Journal of laparoendoscopic & advanced surgical techniques. Part A. 2021
Background: There are several methods used to extract common bile duct (CBD) stones encountered during cholecystectomy. Intraoperative cholangiotomy, cholangioscopy, and laparoscopic CBD exploration (LCBDE) are techniques that allow removal of stones from the CBD during the index procedure. However, bile leakage following CBD exploration is a common problem. The aim of this study was to assess whether fibrin sealant applied to the duct incision is safe. Methods: Patients planned for laparoscopic gallstone surgery at the Department of Surgery, Enköping Hospital, were included in the study. In cases where perioperative cholangiography showed CBD stones, LCBDE was performed through a longitudinal incision in the CBD. Randomization between closure of the incision with polyglactin sutures or with fibrin sealant was performed. After all the stones had been removed and the incision closed according to the allocation, an abdominal drain was placed close to the incision. A T tube was placed in the CBD or a straight tube into cystic duct for eventual postoperative cholangiogram. The patient and the surgeon assessing the postoperative course were blinded to the randomized allocation. Results: Altogether 51 patients were included from December 2012 to July 2016. Mean operative time was 188 minutes in the fibrin sealant group and 214 minutes in the suture group (P = .159). There was no significant difference between groups in bile flow in the abdominal drainage tube or in the CBD drain during the three first postoperative days. The time to removal of the abdominal drain did not differ significantly between groups. Conclusion: Although the present study lacks the statistical power to prove a benefit from fibrin sealant, it indicates that closure of the incision may be an option to reduce the risk for leakage. Further studies are required to confirm this. The study was retrospectively registered on clinicaltrials.gov September 5, 2015 (NCT02545153).
Effect of 0.9% NaCl compared to plasma-lyte on biomarkers of kidney injury, sodium excretion and tubular transport proteins in patients undergoing primary uncemented hip replacement - a randomized trial
BMC nephrology. 2021;22(1):111
BACKGROUND Isotonic saline (IS) is widely used to secure perioperative cardiovascular stability. However, the high amount of chloride in IS can induce hyperchloremic acidosis. Therefore, IS is suspected to increase the risk of acute kidney injury (AKI). Biomarkers may have potential as indicators. METHODS In a double-blinded, placebo-controlled study, 38 patients undergoing primary uncemented hip replacement were randomized to IS or PlasmaLyte (PL). Infusion was given during surgery as 15 ml/kg the first hour and 5 ml/kg the following two hours. Urinary samples were collected upon admission and the day after surgery. As surgery was initiated, urine was collected over the course of 4 h. Hereafter, another urine collection proceeded until the morning. Urine was analyzed for markers of AKI neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1). Arterious and venous blood samples for measurements of pH and plasma electrolytes including chloride (p-Cl) were collected as surgery was initiated, at the end of surgery and the following morning. RESULTS IS induced an increase in p-Cl (111 ± 2 mmol/L after IS and 108 ± 3 after PL, p = 0.004) and a decrease in pH (7.39 ± 0.02 after IS and 7.43 ± 0.03 after PL, p = 0.001). Urinary NGAL excretion increased in both groups (ΔNGAL: 5.5 [4.1; 11.7] μg/mmol creatinine p = 0.004 after IS vs. 5.5 [2.1;9.4] μg/mmol creatinine after PL, p < 0.001). No difference was found between the groups (p = 0.839). Similarly, urinary KIM-1 excretion increased in both groups (ΔKIM-1: IS 115.8 [74.1; 156.2] ng/mmol creatinine, p < 0.001 vs. PL 152.4 [120.1; 307.9] ng/mmol creatinine, p < 0.001). No difference between the groups (p = 0.064). FE(Na) increased (1.08 ± 0.52% after IS and 1.66 ± 1.15% after PL, p = 0.032). ENaC excretion was different within groups (p = 0.019). CONCLUSION A significantly higher plasma chloride and a lower pH was present in the group receiving isotonic saline. However, u-NGAL and u-KIM-1 increased significantly in both groups after surgery despite absence of changes in creatinine. These results indicate that surgery induced subclinical kidney injury. Also, the IS group had a delayed sodium excretion as compared to the PL group which may indicate that IS affects renal sodium excretion differently from PL. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02528448 , 19/08/2015.
Efficacy of Intraoperative Platelet-Rich Plasma Augmentation and Postoperative Platelet-Rich Plasma Booster Injection for Rotator Cuff Healing: A Randomized Controlled Clinical Trial
Orthopaedic journal of sports medicine. 2021;9(6):23259671211006100
BACKGROUND Platelet-rich plasma (PRP) has been applied as an adjuvant treatment for arthroscopic rotator cuff repair (ARCR) to enhance rotator cuff healing. However, it remains debatable whether PRP enhances tendon-to-bone healing. PURPOSE To assess the efficacy of intraoperative augmentation and postoperative injection of PRP that was prepared using the double-spin method and calcium activation without thrombin in patients with ARCR. STUDY DESIGN Randomized controlled trial; Level of evidence, 1; and cohort study; Level of evidence, 3. METHODS A total of 58 patients underwent ARCR using intraoperative PRP augmentation. Half of the patients were randomly assigned to receive an additional ultrasound-guided PRP injection at the repair site at 2 weeks postoperatively (PRP-booster group); the other half did not receive the booster injection (PRP-only group). A control group that did not receive any PRP treatment was retrospectively matched using propensity score matching. Structural integrity was assessed using magnetic resonance imaging at 1 year postoperatively, and healing rates were compared between patients with tear sizes ≤2 cm versus >2 cm. Functional outcomes were assessed using the visual analog scale (VAS) for pain; VAS for satisfaction; shoulder range of motion; and Constant, American Shoulder and Elbow Surgeons, and Simple Shoulder Test scores at minimum 2-year follow-up. RESULTS In patients with tears >2 cm, the rate of healing failure at 1-year follow-up was significantly less in the overall PRP group than in the control group (12.9% vs 35.7%, respectively; P = .040), however, the PRP-booster group did not present a better healing rate than did the PRP-only group. The overall PRP group had lower VAS for pain scores compared with the control group (0.5 ± 1.1 vs 1.3 ± 1.8, respectively; P = .016) and higher VAS for satisfaction scores (9.2 ± 1.2 vs 8.6 ± 1.7; P = .023) at the final follow-up, whereas no statistical difference was found between the PRP-only and PRP-booster groups in functional outcomes. CONCLUSION Intraoperative PRP augmentation during ARCR demonstrated superior anatomic healing results in patients with rotator cuff tears >2 cm as well as reduced pain and increased subjective satisfaction. PRP booster injection provided no additional benefit to tendon integrity or functional recovery.
Visual Acuity, Vitreous Hemorrhage, and Other Ocular Outcomes After Vitrectomy vs Aflibercept for Vitreous Hemorrhage Due to Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial
JAMA ophthalmology. 2021
IMPORTANCE Although there were no differences in mean visual acuity (VA) over 24 weeks after vitrectomy with panretinal photocoagulation (PRP) vs aflibercept in a randomized clinical trial among eyes with vitreous hemorrhage due to proliferative diabetic retinopathy (PDR), post hoc analyses may influence treatment choices. OBJECTIVE To compare exploratory outcomes between treatment groups that may affect treatment choices for patients with vitreous hemorrhage due to PDR. DESIGN, SETTING, AND PARTICIPANTS This post hoc analysis of a randomized clinical trial conducted at 39 DRCR Retina Network sites included adults with vision loss due to PDR-related vitreous hemorrhage for whom vitrectomy was considered. Data were collected from November 2016 to January 2020. INTERVENTIONS Random assignment to 4 monthly injections of aflibercept vs vitrectomy with PRP. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol-specific criteria. MAIN OUTCOMES AND MEASURES Visual acuity area under the curve (adjusted for baseline VA) and clearance of vitreous hemorrhage. RESULTS A total of 205 eyes were included in the analysis (115 male [56%] and 90 [44%] female participants; mean [SD] age, 57  years). Among 89 eyes with a baseline VA of 20/32 to 20/160 (47 receiving aflibercept, including 4 [9%] that had undergone vitrectomy; 42 undergoing vitrectomy, including 3 [7%] that had received aflibercept), the adjusted mean difference in VA letter score over 24 weeks between the aflibercept and vitrectomy groups was -4.3 (95% CI, -10.6 to 1.9) compared with -16.7 (95% CI, -24.4 to -9.1) among 59 eyes with baseline VA worse than 20/800 (P = .02 for interaction; 26 in the aflibercept group, including 6 [23%] that had undergone vitrectomy; 33 in the vitrectomy group, including 8 [24%] that had received aflibercept). In the full cohort, the median time to clearance of the initial vitreous hemorrhage was 36 (interquartile range [IQR], 24-52) weeks in the aflibercept group vs 4 (IQR, 4-4) weeks in the vitrectomy group (difference, 32 [95% CI, 20-32] weeks; P < .001). CONCLUSIONS AND RELEVANCE Both initial aflibercept and vitrectomy with PRP are viable treatment approaches for PDR-related vitreous hemorrhage. Although this study did not find a significant difference between groups in the primary outcome of mean VA over 24 weeks of follow-up, eyes receiving initial vitrectomy with PRP had faster recovery of vision over 24 weeks when baseline VA was worse than 20/800 and faster vitreous hemorrhage clearance. Approximately one-third of the eyes in each group received the alternative treatment (aflibercept or vitrectomy with PRP). These factors may influence treatment decisions for patients initiating therapy for PDR-related vitreous hemorrhage. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02858076.