External Soft-Tissue Hemostatic Clamp Compared to a Compression Tourniquet as Primary Hemorrhage Control Device in Pilot Flow Model Study

2019 ◽  
Vol 34 (02) ◽  
pp. 175-181 ◽  
Author(s):  
Roland Paquette ◽  
Ryan Bierle ◽  
David Wampler ◽  
Paul Allen ◽  
Craig Cooley ◽  
...  

Introduction:Acute blood loss represents a leading cause of death in both civilian and battlefield trauma, despite the prioritization of massive hemorrhage control by well-adopted trauma guidelines. Current Tactical Combat Casualty Care (TCCC) and Tactical Emergency Casualty Care (TECC) guidelines recommend the application of a tourniquet to treat life-threatening extremity hemorrhages. While extremely effective at controlling blood loss, the proper application of a tourniquet is associated with severe pain and could lead to transient loss of limb function impeding the ability to self-extricate or effectively employ weapons systems. As a potential alternative, Innovative Trauma Care (San Antonio, Texas USA) has developed an external soft-tissue hemostatic clamp that could potentially provide effective hemorrhage control without the aforementioned complications and loss of limb function. Thus, this study sought to investigate the effectiveness of blood loss control by an external soft-tissue hemostatic clamp versus a compression tourniquet.Hypothesis:The external soft-tissue hemostatic clamp would be non-inferior at controlling intravascular fluid loss after damage to the femoral and popliteal arteries in a normotensive, coagulopathic, cadaveric lower-extremity flow model using an inert blood analogue, as compared to a compression tourniquet.Methods:Using a fresh cadaveric model with simulated vascular flow, this study sought to compare the effectiveness of the external soft-tissue hemostatic clamp versus the compression tourniquet to control fluid loss in simulated trauma resulting in femoral and posterior tibial artery lacerations using a coagulopathic, normotensive, cadaveric-extremity flow model. A sample of 16 fresh, un-embalmed, human cadaver lower extremities was used in this randomized, balanced two-treatment, two-period, two-sequence, crossover design. Statistical significance of the treatment comparisons was assessed with paired t-tests. Results were expressed as the mean and standard deviation (SD).Results:Mean intravascular fluid loss was increased from simulated arterial wounds with the external soft-tissue hemostatic clamp as compared to the compression tourniquet at the lower leg (119.8mL versus 15.9mL; P <.001) and in the thigh (103.1mL versus 5.2mL; P <.001).Conclusion:In this hemorrhagic, coagulopathic, cadaveric-extremity experimental flow model, the use of the external soft-tissue hemostatic clamp as a hasty hemostatic adjunct was associated with statistically significant greater fluid loss than with the use of the compression tourniquet.Paquette R, Bierle R, Wampler D, Allen P, Cooley C, Ramos R, Michalek J, Gerhardt RT. External soft-tissue hemostatic clamp compared to a compression tourniquet as primary hemorrhage control device in pilot flow model study. Prehosp Disaster Med. 2019;34(2):175–181

1989 ◽  
Vol 7 (9) ◽  
pp. 1217-1228 ◽  
Author(s):  
A E Chang ◽  
S M Steinberg ◽  
M Culnane ◽  
M H Lampert ◽  
A J Reggia ◽  
...  

We have documented functional and psychosocial changes in patients with extremity soft tissue sarcomas who have undergone multimodality limb-sparing treatments. In 88 patients, parameters related to economic status, sexual activity, pain, limb function, and global quality of life (QOL) were recorded prior to surgery and every 6 months postoperatively. Changes from the preoperative assessment for every parameter were analyzed in each patient. Six months after surgery, there was a decrease in employment status, sexual activity, and in limb function in a significant number of patients. At 12 months, these decreases were still evident. Despite these changes, global QOL measured by a standardized test showed at least some improvement in a significant proportion of patients at 12 months. These findings highlight the difficulty in defining QOL. It could not be ascertained if radiation therapy and/or chemotherapy were causative factors in specific changes because of the small numbers of patients in each subgroup. However, among 60 patients with high-grade sarcomas, significant wound problems developed in 10 of 33 who received postoperative radiation therapy in combination with adjuvant doxorubicin and cyclophosphamide chemotherapy compared with one of 27 patients who received adjuvant chemotherapy alone (P = .016). Also, among high-grade sarcoma patients with 12-month follow-up, six of 19 patients who received radiation therapy and chemotherapy developed joint contractures compared with zero of 15 patients who received chemotherapy alone (P less than .04). The combination of postoperative radiation therapy and chemotherapy appeared to be associated with significantly more tissue-related injury in patients with high-grade sarcomas compared with chemotherapy alone.


Circulation ◽  
2018 ◽  
Vol 138 (Suppl_2) ◽  
Author(s):  
Nathan P Charlton ◽  
Robert Solberg ◽  
Justin Rizer ◽  
Eunice Singletary ◽  
William Woods

Introduction: Hemorrhage is the primary cause of death in 35% of traumatic mortalities. However, guidelines give little guidance regarding the best method of applying direct pressure including the mechanics of applying the pressure. Hypothesis: The purpose of this study is to compare the force generated using different techniques of force application. Additionally, we aimed to measure the pressure generated by a pressure wrap using two commonly used types of bandages in comparison to manual pressure. Methods: In this IRB approved study, subjects were recruited as a convenience sample of medical providers during a weekly medical conference. A standardized bleeding simulator (Z-Medica) with a flat force sensitive resistor was used in this study to measure force. Subjects were randomized to application order of each of the following techniques: the finger pads of 3 digits of the right hand, 3 fingers of the right hand with the opposing hand applying counter pressure, or 3 digits of each of two hands on top of the other. The subjects were asked to hold pressure at each application for 10 seconds and all completed each method sequentially. Subjects then applied a compression wrap using either an elastic wrap or self-adhesive wrap. Researchers were not blinded during data collection, but data analysts were blinded to the groups. Results: Thirty-three subjects were enrolled and all had data available for analysis. Twenty-two were residents, 11 attending physicians, 22 were male, and the average age was 34.2 years (range 26-63). Two hand pressure application generated the most amount of force averaging a constant of 3.75 (SD 1.54) lbs. This was statistically different from one hand application which generated an average of 3.00 (SD 1.29) lbs of force (p <0.001). Comparison of opposing hands to single hand and two hands to opposing hands did not reach statistical significance. Neither pressure wrap technique generated a comparable amount of force to that of manual pressure [0.70 (SD 0.49) lbs vs 1 hand with 10 4x4” gauze pads (p <0.001)]. Conclusions: In this model of bleeding, medical personnel generated the most force when two hands were used to apply pressure over the wound. This study also demonstrated direct manual pressure generated much higher pressures than a pressure dressing.


2022 ◽  
Vol 226 (1) ◽  
pp. S716
Author(s):  
Rachel P. Gerber ◽  
Monique De Four Jones ◽  
Michael Nimaroff ◽  
Burton Rochelson ◽  
Moti Gulersen

2014 ◽  
Vol 26 (9) ◽  
pp. 983-991 ◽  
Author(s):  
Célia C. Alves ◽  
Fernando Muñoz ◽  
António Cantalapiedra ◽  
Isabel Ramos ◽  
Manuel Neves ◽  
...  

2018 ◽  
Vol 23 (2) ◽  
pp. 403-407 ◽  
Author(s):  
Takeshi Morii ◽  
Tomonori Kishino ◽  
Naoko Shimamori ◽  
Mitsue Motohashi ◽  
Hiroaki Ohnishi ◽  
...  

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ahmed Refaat Mohamed Refaat ◽  
Gamal Samy ◽  
Faisal Morad ◽  
Nabil Abd Gawad

Abstract Background ​ In the era of minimal invasive cardiac surgery, Ministernotomy Aortic valve .replacement have been proposed as an alternative to conventional full sternotomy approach Aim of the Work ​: ​​To evaluate the safety and efficacy of AVR through ministernotomy in comparison to full sternotomy AVR in terms of Cardiac cause mortality, Neurological and .Renal complication​s Patients and Methods ​After gaining the institutional ethical committee approval, the study included all patients who underwent isolated, DE novo, open aortic valve replacement during the period from June 2017 till June 2019 performed by multiple surgeons at cardiothoracic .academy Ain Shams University Results ​ The study included 60 patients; 32 patients performed through full sternotomy (53.3%) and 28 patients through ministernotomy (46.6%).​ ​Post-operative arrhythmias occurred in full sternotomy in 6 cases (18.8%) where in mini-sternotomy, only 3 cases (12%) developed arrhythmias with no significant statistical difference (p value = ​0.558)​. Cerebrovascular stroke was recorded 1 patient (3%) versus 4 cases (14.3%) in the full sternotomy versus the ministernotomy groups respectively with no Statistical difference between the 2 groups (p value = 0.119).​ Postoperative acute renal impairment was recorded​ in 3 cases (9.4%) vs 2 patients (7.1%) in the full sternotomy vs the ministernotomy groups respectively (p value = 0.755). There was no​ mortality in either groups. Mean post-operative Ventilation hours were 17.21hrs with SD ± 11.026 versus 14.97hrs with SD ​± ​6.473 (p value is 0.35) for the full sternotomy versus the ministernotomy groups respectively. Mean blood loss was 305.51ml with SD ± 282.662 versus 230.36ml with SD ​± ​247.708 (p value is 0.277) for the full versus the ministernotomy groups respectively. Mean units of blood transfused was 2.31Units with SD ​± ​0.926 versus 1.14Units with SD ​±​ 0.591 in the full sternotomy versus the ministernotomy groups with high statistical significance between both groups (p value less than 0.01). Mean ICU stay was 2.66 days with SD ​±​ 0.915 and was 3.1days with SD ​±​ 2.743 (p .value is 0.424) for the full sternotomy versus the ministernotomy groups respectively Conclusion ​ Ministernotomy Aortic valve replacement was found to be a safe procedure​ compared to full sternotomy approach. Patients who had their surgery through the mini approach had less amount of blood loss, blood transfusion requirements, ventilation time which all led to less duration of ICU and hospital stay, resulting in a better outcome for the .patients


2020 ◽  
Vol 136 (5) ◽  
pp. 882-891 ◽  
Author(s):  
Mary E. D’Alton ◽  
Kara M. Rood ◽  
Marcela C. Smid ◽  
Hyagriv N. Simhan ◽  
Daniel W. Skupski ◽  
...  

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e035546
Author(s):  
Leopold Hentschel ◽  
Stephan Richter ◽  
Hans-Georg Kopp ◽  
Bernd Kasper ◽  
Annegret Kunitz ◽  
...  

ObjectivesThe choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.DesignYonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.ParticipantsSix hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.Primary and secondary outcome measuresThe primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.ResultsAfter 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: −2.4, 95% CI: −9.2 to 4.5) as compared with CA (ΔFACT-G total score: −3.9; 95% CI:−11.3 to 3.5; p=0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p=0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.ConclusionOur data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.Trial registration numberClinicalTrials.gov Identifier (NCT02204111).


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