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1.
Blood ; 115(9): 1797-803, 2010 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-19965682

RESUMO

Heparin can induce heparin-induced thrombocytopenia (HIT). The combined effect of type of surgery (major vs minor) and heparin on this prothrombotic immune reaction to platelet factor 4 (PF4)/heparin was analyzed. In a randomized, double-blind study, trauma patients receiving low-molecular-weight (LMWH) or unfractionated heparin (UFH) for thrombosis prophylaxis were assessed for PF4/heparin-antibody seroconversion, HIT, and thrombosis according to type of surgery. The risk for seroconversion was higher than major versus minor surgery odds ratio, 7.98 [95% confidence interval, 2.06-31.00], P = .003, controlled for potential confounders, as was the risk for HIT (2.2% [95% confidence interval, 0.3%-4.1%] vs 0.0%, P = .010). During LMWH compared with UFH thromboprophylaxis, HIT (1 of 298 vs 4 of 316; P = .370) and PF4/heparin seroconversion (1.7% vs 6.6%; P = .002) were less frequent, driven by differences in patients undergoing major surgery (incidence of HIT: LMWH 0.8% vs UFH 4.0%; P = .180; seroconversion rates: 4.0% vs 17.0%; P = .001). After minor surgery, no case of HIT occurred. The severity of trauma and the need for major surgery strongly influence the risk of an anti-PF4/heparin immune response, which is then increased by UFH. In major trauma certoparin may be safer than UFH because it induces HIT-antibody seroconversion, and the corresponding risk of HIT, less frequently.


Assuntos
Heparina/efeitos adversos , Heparina/imunologia , Fator Plaquetário 4/imunologia , Trombocitopenia/induzido quimicamente , Ferimentos e Lesões/tratamento farmacológico , Ferimentos e Lesões/imunologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Anticoagulantes/imunologia , Método Duplo-Cego , Feminino , Heparina de Baixo Peso Molecular/efeitos adversos , Heparina de Baixo Peso Molecular/imunologia , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/prevenção & controle , Fatores de Risco , Trombocitopenia/imunologia , Trombose/prevenção & controle , Ferimentos e Lesões/complicações , Adulto Jovem
2.
Phlebology ; 29(1 suppl): 7-12, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24843079

RESUMO

Objectives: To assess the clinical safety of a new short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) in patients with peripheral arterial occlusive disease (PAOD). This system combines a low resting pressure with a high working pressure. Methods: A pilot study was performed in 15 subjects with moderate PAOD, i.e. an ABPI of 0.5-0.8. Co-existing chronic venous insufficiency or leg ulcer was not mandatory. All subjects received the compression system which was reapplied at each study visit (days 1, 2, 3, 4, 7, 10, 14). The safety parameters were: sub-bandage pressure immediately after application, pressure-related skin damage, hypoxia-related pain, and adverse events. A product comfort questionnaire was completed at the last visit. Results: The average sub-bandage pressure of 30 mmHg defined by the protocol was achieved. No pressure-related skin damage or hypoxia-related pain was found. The reported adverse device effects were as expected for compression therapies, including dry skin and pruritus. The product comfort questionnaire completed by the subjects showed a good tolerability profile. Conclusion: The short-stretch 2-layer compression system (3Mtm Cobantm 2 Lite) was safe and well tolerated in subjects with moderate PAOD.

3.
Clin Hemorheol Microcirc ; 53(3): 281-93, 2013 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-22885870

RESUMO

OBJECTIVE: To investigate macro- and microperfusion during 14 days of treatment with a new 2-layer compression system (3M™ Coban™ 2 Lite), designed for patients with leg ulcer and concomitant peripheral arterial occlusive disease. METHODS: A single-centre, open-label, prospective pilot study was performed with 15 subjects suffering from peripheral arterial occlusive disease with an ankle brachial pressure index (ABPI) of 0.5-0.8, who volunteered to have their 'study leg' bandaged with the new system. Coincident leg ulcer or chronic venous disease was not mandatory. All subjects received the new compression system, which stayed in place from 1 up to 4 days according to scheduled study visits. The system was reapplied by study personnel at each clinical visit (days 1, 2, 3, 4, 7, 10 and 14). The study participation stopped after 14 days. At each clinical visit safety assessments were performed: measurement of acral pulsation to capture macroperfusion; laser Doppler fluxmetry to capture microperfusion; clinical signs of pressure related skin damage, hypoxia-related pain and sub-bandage pressure measurement. In addition, the leg volume was measured and a comfort questionnaire was completed. RESULTS: An average sub-bandage pressure in standing position of approximately 30 mmHg was measured at the B1 location immediately after bandage application. Laser Doppler fluxmetry demonstrated positive effects on microcirculation regarding vasomotion and respiratory reflux. No change of the cardiac signal appeared. For acrale pulsations a high intraindividual variability was found with no clear interference to the bandage application. No pressure-related skin damage or hypoxia-related pain was detected. CONCLUSION: After application of the new compression system in subjects with moderate PAOD, laser Doppler fluxmetry indicated significant improvements of the microcirculation. High variability and lack of correlation to clinical symptoms was found for the acral pulsation. The new compression system revealed a high grade of tolerability and a good safety profile.


Assuntos
Bandagens Compressivas , Úlcera da Perna/complicações , Perna (Membro)/irrigação sanguínea , Doença Arterial Periférica/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Fluxometria por Laser-Doppler , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/complicações , Projetos Piloto , Estudos Prospectivos
4.
Am J Infect Control ; 39(2): 98-103, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-20864217

RESUMO

BACKGROUND: Surgical gloves provide a protective barrier for patients and members of the surgical team. Although glove integrity is important in an era of blood-borne pathogens, little data exist on bacterial passage after glove perforation. This study evaluated the impact of antimicrobial surgical gloves in reducing microbial passage after glove puncture in a model of wound contamination. METHODS: Staphylococcus aureus (ATCC 6538) and Brevundimonas diminuta (DSM 1639) were used to prepare a standardized suspension for testing bacterial passage after glove puncture in volunteers wearing single-layer gloves (group A), double-layer gloves (group B), or antimicrobial trilayer gloves (group C). After exposure periods of 5, 10, 30 and 45 minutes, the outer test gloves were removed and microbial passage was measured on the inner surface of the base gloves. Multiple repetitions (5 or 6) were performed at each sampling time. RESULTS: Microbial passage at 5-, 10-, 30-, and 45-minute exposures were analyzed both separately and combined (5 and 10 minutes and 30 and 45 minutes). No difference was observed in microbial passage between group A and group B at the 10-, 30-, and 45-minute exposures for S aureus, whereas a significant reduction in microbial passage was observed in group C compared with group A (P ≤ .05 to < .005) at the 5-, 30-, and 45-minute exposures for both S aureus and B diminuta. When timed groups were combined (5 and 10 minutes and 30 and 45 minutes), a significant reduction (P ≤ .01 to ≤ .005) in microbial passage of S aureus and B diminuta was observed in group C compared with both group A and group B. CONCLUSION: These findings represent the first evidence that microbial passage across surgical gloves can be reduced significantly using an innovative antimicrobial glove technology.


Assuntos
Luvas Cirúrgicas/microbiologia , Infecção dos Ferimentos/prevenção & controle , Anti-Infecciosos , Caulobacter , Humanos , Técnicas In Vitro , Período Intraoperatório , Staphylococcus aureus
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