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Amputation Wound clinical trials

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NCT ID: NCT03960463 Recruiting - Breast Cancer Clinical Trials

EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

Start date: May 18, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds. The investigators hypothesize that using this novel oxygen diffusion dressing will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.

NCT ID: NCT03934281 Completed - Amputation Clinical Trials

Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient

MELIDIAB
Start date: June 27, 2018
Phase: N/A
Study type: Interventional

Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey. Honey is effective in the management of many infected or uninfected post-surgical wounds. This study focuses on post surgical wounds after toe amputation in diabetic patients. The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations

NCT ID: NCT03611361 Terminated - Clinical trials for Peripheral Arterial Disease

Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients

WISCR
Start date: November 18, 2015
Phase:
Study type: Observational

This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.

NCT ID: NCT03144726 Not yet recruiting - Infection Clinical Trials

RCT on NPWT for Incisions Following Major Lower-limb Amputation to Reduce Surgical Site Infection

Start date: March 2018
Phase: N/A
Study type: Interventional

Surgical site infections following lower extremity amputations have been reported in up to 40% of patients. Surgical site infections have significant morbidity and even mortality in terms of emergency room visits, length of hospital stay, reamputation rates and death. Since its introduction, negative pressure wound therapy has been demonstrated to promote wound healing and possibly decreasing the need for future amputations. The aim of the study is to provide level I evidence for the use of negative pressure wound therapy devices in patients undergoing lower extremity amputation.

NCT ID: NCT02018094 Completed - Wound Infection Clinical Trials

The Amputation Surgical Site Infection Trial (ASSIT)

ASSIT
Start date: October 8, 2013
Phase: Phase 4
Study type: Interventional

- Lower limb amputations are performed usually as a last resort in patients with acute and chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes or, infection. - In the period 2003-2008 there were approximately 5,000 amputations per year in the UK. - The Centre for Disease Control defines a Surgical Site Infection (SSI) as an infection within 30 days of an operation or up to one year if an implant is left in place and the infection is related to an operative procedure. - Figures from the Surgical Site Infection Surveillance reported that the highest rate of surgical site infection was reported in association with lower limb amputation at 13.1%. - There is a clear under-representation and the infection rate within our institution is approximately 25% which reflects the infection rate reported in a recent trial by Sadat et al (22.5%) - Prevention of surgical site infections is of paramount importance to patients, healthcare providers and policy-makers, as they impact on morbidity and mortality and have significant time and cost implications. - Currently there is NO CONSENSUS as to what the best practice is towards antibiotic administration in such patients. From a questionnaire-based audit we performed including vascular departments across the entire country, practice varies in both course duration (single dose → 5 days antibiotic course) as well as choice of antibiotics. - The guideline at our institution suggests the 5-day course of antibiotic prophylaxis. The course duration varies depending on the clinical picture as well as microbiology results and recommendations. - There are no randomised control trials that have investigated this aspect of patient care. We have set up one such trial and through it, we are looking to establish a standard practice which will hopefully be as beneficial as possible to the patient but also cost-effective for NHS.

NCT ID: NCT01897103 Completed - Clinical trials for Peripheral Artery Disease

Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

PIVOTAL
Start date: June 2013
Phase: N/A
Study type: Observational

The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.

NCT ID: NCT01703182 Terminated - Amputation Wound Clinical Trials

Transcutaneous Oximetry, Transcutaneous Carbon Dioxide and Supplemental Oxygen Therapy in Lower Limb Amputations

TCOM
Start date: April 2011
Phase: N/A
Study type: Observational

TCOM is a multicentre prospective cohort study in patients undergoing lower limb amputations. Patients will provide oxygen and carbon dioxide measurements in the lower limb for 20 to 30 minutes before their surgery and will be followed up until 6 months after their surgery. The purpose of the TCOM study is to determine the ability of oxygen and carbon dioxide measurements in the legs of patients undergoing lower limb amputation to predict wound healing complications and to determine an optimum cutoff value for both oxygen and carbon dioxide levels beyond which healing complications are likely to occur and a closer amputation level is indicated.

NCT ID: NCT00932399 Completed - Amputation Wound Clinical Trials

Longitudinal Study of Weight Change Following Lower Limb Amputation

Start date: March 2010
Phase: N/A
Study type: Observational

The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation. It is widely believed that many patients experience weight gain following amputation. This study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. Information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.