A Meta-analysis of the Types and Outcomes of Conservative Excisional Surgery for Recalcitrant or Infected Diabetic Toe Ulcers

2019 ◽  
Vol 13 (2) ◽  
pp. 152-160 ◽  
Author(s):  
Kaissar Yammine ◽  
Chahine Assi

Although they occur frequently, diabetic toe ulcers (DTUs) are poorly investigated. Long-term antibiotics or toe amputation are the usual indications for complicated DTU treatment. Some authors reported good to excellent results following conservative surgery (CS) for recalcitrant or infected wounds; yet no systematic review has been published. Seven studies, comprising 290 patients with 317 ulcers, met the inclusion criteria of this meta-analysis. Three types of CS were found: resection arthroplasty of the interphalangeal joint, toe-sparing bone excision (internal pedal amputation), and distal Symes amputation. The meta-analytical results were as follows: healing rate of 98.3%, healing time of 6.8 ± 3.9 weeks, recurrence rate of 2.3%, wound dehiscence/recurrent infection rate of 6.4%, skin necrosis rate of 2.8%, and revision surgery rate of 7.4%. Subgroup analyses showed no significant differences in outcomes between recalcitrant ulcers and infected ulcers nor between surgery types. Significance was found in relation to ulcer location; when compared with the hallux, DTU on the lesser toes demonstrated better outcomes. Compared with the reported overall results of standard of care associated with antibiotics or toe amputation of complicated DTUs in the literature, CS seems to be a better option for the treatment of recalcitrant or infected DTUs. Levels of Evidence: Level III

ESMO Open ◽  
2018 ◽  
Vol 3 (4) ◽  
pp. e000343 ◽  
Author(s):  
Davide Mauri ◽  
George Zarkavelis ◽  
Panagiotis Filis ◽  
Lampriani Tsali ◽  
Georgia Zafeiri ◽  
...  

Surgical resection is the only option of cure for patients with metastatic colorectal cancer. Risk of recurrence after metastasectomy is around 75%. Use of adjuvant chemotherapy after metastasectomy is controversial.AimTo address whether adjuvant systemic therapy after colorectal cancer metastasectomy offers any survival benefit compared with surgery alone.MethodsSystematic review of literature and meta-analysis of all available randomised evidence. Relative hazards (RHs) were summarised across trials and heterogeneity was assessed with the Q and I2 statistics.ResultsFive trials were eligible. Three trials, all using single-agent fluoropyrimidine chemotherapy, presented data valuable for analyses. 482 patients were included in the meta-analysis: 238 randomly assigned to receive postoperative chemotherapy and 244 to metastasectomy only. We found no overall survival (OS) benefit with the use of postoperative single-agent fluoropyrimidines compared with surgery alone, even if a trend for benefit was observed (relative hazard (RH)=0.781, 95% CI 0.593 to 1.030, p=0.080). Significant disease-free survival benefit with the use of postoperative chemotherapy was observed (RH=0.645, 95% CI 0.509 to 0.818, p=0.001). No quality of life (QL) data were available. All trials showed accrual delay, two stopped and one recruiting after 10 years. Long follow-up needs were evidenced since OS curves split only after 3.5 years.ConclusionsNo OS benefit was documented from the use of postoperative monochemotherapy. Metastasectomy alone continues to be the standard of care. Combination chemotherapy regimens should be evaluated along with QL assessment in future trials appropriately designed for long-term accrual and follow-up.


Author(s):  
Francesca Mori ◽  
Mattia Giovannini ◽  
Simona Barni ◽  
Rodrigo Jiménez-Saiz ◽  
Daniel Munblit ◽  
...  

The prevalence of food allergy has increased in recent years, especially in children. Food allergen avoidance and symptomatic drugs in case of an allergic reaction remain the standard of care in food allergy. Nevertheless, increasing attention has been given to the possibility to treat food allergy, through immunotherapy, particularly oral immunotherapy (OIT). Several OIT protocols and clinical trials have been published. Most of them focus on children allergic to milk, egg, or peanuts, although recent studies developed protocols for other foods, such as wheat and different nuts. OIT efficacy in randomized controlled trials is usually evaluated as the possibility for patients to achieve desensitization, while the issue of a possible long-term sustained unresponsiveness has not been completely addressed. Here, we evaluated current OIT knowledge, focusing on the results of clinical trials and current guidelines. Specifically, we wanted to highlight what is known in terms of OIT efficacy and effectiveness, safety, and impact on quality of life. For each aspect, we reported the pros and the cons, inferable from published literature. In conclusion, even though many protocols, reviews and meta-analysis have been published on this topic, OIT remains a controversial therapy and no definitive generalized conclusion may be drawn so far. It should be an option provided by specialized teams, when both patients and their families are prone to adhere to the proposed protocol. Efficacy, long-term effectiveness, possible role of adjuvant therapies, risk of severe reactions including anaphylaxis or eosinophilic esophagitis, and impact on the quality of life of both children and caregivers are all aspects that should be discussed before starting OIT. Future studies are needed to provide firm clinical and scientific evidence, which should also consider patient reported outcomes.


Author(s):  
Justine Ring ◽  
Martina Heinelt ◽  
Shubham Sharma ◽  
Sasha Letourneau ◽  
Marc G Jeschke

Abstract Severe burns induce a profound hypermetabolic response, leading to a prolonged state of catabolism associated with organ dysfunction and delay of wound healing. Oxandrolone, a synthetic testosterone analog, may alleviate the hypermetabolic catabolic state thereby decreasing associated morbidity. However, current literature has reported mixed outcomes on complications following Oxandrolone use, specifically liver and lung function. We conducted an updated systematic review and meta-analysis studying the effects of Oxandrolone on mortality, length of hospital stay, progressive liver dysfunction, and nine secondary outcomes. We searched Pubmed, EMBASE, Web of Science, CINAHL, and Cochrane Databases of Systematic Reviews and Randomized Controlled Trials. Thirty-one randomized control trials and observational studies were included. Basic science and animal studies were excluded. Only studies comparing Oxandrolone to standard of care, or placebo, were included. Oxandrolone did not affect rates of mortality (relative risk [RR]: 0.72; 95% confidence interval [CI]: 0.47 to 1.08; P = .11) or progressive liver dysfunction (RR: 1.04; 95% CI: 0.59 to 1.85; P = .88), but did decrease length of stay in hospital. Oxandrolone significantly increased weight regain, bone mineral density, percent lean body mass, and decreased wound healing time for donor graft sites. Oxandrolone did not change the incidence of transient liver dysfunction or mechanical ventilation requirements. There is evidence to suggest that Oxandrolone is a beneficial adjunct to the acute care of burn patients; shortening hospital stays and improving several growth and wound healing parameters. It does not appear that Oxandrolone increases the risk of progressive or transient liver injury, although monitoring liver enzymes is recommended.


2021 ◽  
Vol 12 ◽  
Author(s):  
Francesca Mori ◽  
Mattia Giovannini ◽  
Simona Barni ◽  
Rodrigo Jiménez-Saiz ◽  
Daniel Munblit ◽  
...  

The prevalence of food allergy has increased in recent years, especially in children. Allergen avoidance, and drugs in case of an allergic reaction, remains the standard of care in food allergy. Nevertheless, increasing attention has been given to the possibility to treat food allergy, through immunotherapy, particularly oral immunotherapy (OIT). Several OIT protocols and clinical trials have been published. Most of them focus on children allergic to milk, egg, or peanut, although recent studies developed protocols for other foods, such as wheat and different nuts. OIT efficacy in randomized controlled trials is usually evaluated as the possibility for patients to achieve desensitization through the consumption of an increasing amount of a food allergen, while the issue of a possible long-term sustained unresponsiveness has not been completely addressed. Here, we evaluated current pediatric OIT knowledge, focusing on the results of clinical trials and current guidelines. Specifically, we wanted to highlight what is known in terms of OIT efficacy and effectiveness, safety, and impact on quality of life. For each aspect, we reported the pros and the cons, inferable from published literature. In conclusion, even though many protocols, reviews and meta-analysis have been published on this topic, pediatric OIT remains a controversial therapy and no definitive generalized conclusion may be drawn so far. It should be an option provided by specialized teams, when both patients and their families are prone to adhere to the proposed protocol. Efficacy, long-term effectiveness, possible role of adjuvant therapies, risk of severe reactions including anaphylaxis or eosinophilic esophagitis, and impact on the quality of life of both children and caregivers are all aspects that should be discussed before starting OIT. Future studies are needed to provide firm clinical and scientific evidence, which should also consider patient reported outcomes.


Author(s):  
Dinh Thien-An Tran ◽  
Rosa Klotz ◽  
Julian C. Harnoss ◽  
Patrick Heger ◽  
Alina S. Ritter ◽  
...  

Abstract Background Patients undergoing relaparotomy are generally underrepresented in trials, despite how common the procedure is in clinical practice. The aim of this trial was to determine standard of care and gain evidence of intra- and postoperative outcomes for patients undergoing relaparotomy compared to primary laparotomy. Methods In this single-center controlled clinical trial, adult patients scheduled for elective abdominal surgery via relaparotomy or primary laparotomy were consecutively screened for eligibility. The perioperative course was monitored prospectively in five study visits during hospital stay and one study visit 1 year after surgery. Intraoperative standards, short and long-term outcomes were statistically explored at a level of significance of 5%. Results A total of 131 patients with relaparotomy and 50 patients with primary laparotomy were analyzed. In the relaparotomy group, the access to the abdomen took longer (23.5 min vs. 8.8 min; p = < 0.001) and the peritoneal adhesion index was higher (10.8 vs. 0.4; p = < 0.001). Inadvertent enterotomies were more frequent in the relaparotomy group (relaparotomy 0.3 versus primary laparotomy: 0.0; p = 0.002). The overall comprehensive complication index and rates of surgical site infection and wound dehiscence with evisceration were not different between the two groups. At long-term follow-up, rates of incisional hernia did not differ (relaparotomy: n = 12/104 (11.5%); primary laparotomy: n = 7/35 (20.0%); p = 0.208). Discussion In this first prospective comparison of relaparotomy with primary laparotomy, inadvertent enterotomies were more frequent in the relaparotomy group. However, contrary to previous retrospective studies, the risk of complications and incisional hernias was not increased compared to primary laparotomy. Trial Registration Deutsches Register Klinischer Studien (www.germanctr.de): DRKS00013001


2020 ◽  
Vol 166 (5) ◽  
pp. 352-357 ◽  
Author(s):  
Jiamei Li ◽  
W Liu ◽  
G Zhang ◽  
D Wang ◽  
H Lou ◽  
...  

IntroductionIt is uncertain whether treatment by recombinant human granulocyte macrophage colony-stimulating factor (rhGM-CSF) can promote healing of deep second-degree burns. This meta-analysis aimed to systematically review and assess randomised controlled trials (RCTs) that investigated the efficacy and safety of rhGM-CSF for treating deep second-degree burns.MethodsThis meta-analysis conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. The PubMed, Cochrane Library, Medline and Embase databases and relevant references were systematically searched for RCTs (published up to November 2019). Main outcome measures included the wound healing rate, wound healing time and average optical densities of the vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF). We performed a meta-analysis using fixed or random effects models.ResultsSeven RCTs comprising 982 patients with 1184 burns (652 patients received rhGM-CSF vs 532 controls) were included. Compared with standard wound care alone, the use of rhGM-CSF significantly reduced wound healing time by 4.77 days (weighted mean difference=−4.77; 95% CI −6.45 to −3.09; p<0.001) and significantly increased the wound healing rate on days 7, 10, 14 and 20 by 6.46%, 19.78%, 17.07% and 11.38%, respectively. There was no significant difference between the groups in the wound healing rate on day 28 and average optical densities of VEGF and FGF. No systematic adverse event occurred. Redder, more swollen and painful wounds were reported after using rhGM-CSF compared with the control.ConclusionsrhGM-CSF could be effective and safe for treating deep second-degree burns.


2020 ◽  
Author(s):  
Hanna Algattas ◽  
Pradeep Setty ◽  
Ezequiel Goldschmidt ◽  
Eric W. Wang ◽  
Elizabeth Tyler-Kabara ◽  
...  

2019 ◽  
Vol 24 (5) ◽  
pp. 558-571 ◽  
Author(s):  
Kartik Bhatia ◽  
Hans Kortman ◽  
Christopher Blair ◽  
Geoffrey Parker ◽  
David Brunacci ◽  
...  

OBJECTIVEThe role of mechanical thrombectomy in pediatric acute ischemic stroke is uncertain, despite extensive evidence of benefit in adults. The existing literature consists of several recent small single-arm cohort studies, as well as multiple prior small case series and case reports. Published reports of pediatric cases have increased markedly since 2015, after the publication of the positive trials in adults. The recent AHA/ASA Scientific Statement on this issue was informed predominantly by pre-2015 case reports and identified several knowledge gaps, including how young a child may undergo thrombectomy. A repeat systematic review and meta-analysis is warranted to help guide therapeutic decisions and address gaps in knowledge.METHODSUsing PRISMA-IPD guidelines, the authors performed a systematic review of the literature from 1999 to April 2019 and individual patient data meta-analysis, with 2 independent reviewers. An additional series of 3 cases in adolescent males from one of the authors’ centers was also included. The primary outcomes were the rate of good long-term (mRS score 0–2 at final follow-up) and short-term (reduction in NIHSS score by ≥ 8 points or NIHSS score 0–1 at up to 24 hours post-thrombectomy) neurological outcomes following mechanical thrombectomy for acute ischemic stroke in patients < 18 years of age. The secondary outcome was the rate of successful angiographic recanalization (mTICI score 2b/3).RESULTSThe authors’ review yielded 113 cases of mechanical thrombectomy in 110 pediatric patients. Although complete follow-up data are not available for all patients, 87 of 96 (90.6%) had good long-term neurological outcomes (mRS score 0–2), 55 of 79 (69.6%) had good short-term neurological outcomes, and 86 of 98 (87.8%) had successful angiographic recanalization (mTICI score 2b/3). Death occurred in 2 patients and symptomatic intracranial hemorrhage in 1 patient. Sixteen published thrombectomy cases were identified in children < 5 years of age.CONCLUSIONSMechanical thrombectomy may be considered for acute ischemic stroke due to large vessel occlusion (ICA terminus, M1, basilar artery) in patients aged 1–18 years (Level C evidence; Class IIb recommendation). The existing evidence base is likely affected by selection and publication bias. A prospective multinational registry is recommended as the next investigative step.


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