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Search Results within category "Injury, Trauma & Emergency Medicine"

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Suggestions within category "Injury, Trauma & Emergency Medicine"


5 Study Matches

Immunonutrition Supplementation for Improved Burn Wound Healing in Older Adults

This pilot study aims to assess the feasibility of providing immunonutrition supplementation to older burn patients (age 55 and older) and its impact on burn wound healing. Supplements containing arginine and omega 3 fatty acids have been shown to have beneficial effects on healing in other types of wounds but data within the burn population remains limited. 20 participants will be randomized into two arms, immunonutrition or conventional supplement and can expect to be on study for 3 months.
Rebecca Busch
All
55 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04725071
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Inclusion Criteria:

• Subject has partial of full thickness thermal injury of 1-15% of total body surface area (TBSA)
• Subject has an inpatient admission for their burn
• Subject or authorized decision maker understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
Exclusion Criteria:

• Subject with inhalation injury and/or intubation
• Subject receiving immunosuppressive medications including chronic steroids, immune modulating medications, and chemotherapy prior to admission
• Subject with pre-existing severe chronic liver disease or end stage renal disease
Burn Wound, Burn of unspecified body region, unspecified degree, Burns and corrosions of external body surface, Burns involving 10-19% of body surface area, Burns involving less than 10% of body surface, Other, Injury, Trauma & Emergency Medicine, Food & Nutrition, Skin & Dermatology
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Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

10 participants with Recurrent Chronic Exertional Compartment Syndrome (R-CECS) will be enrolled in a 6 month study at the University of Wisconsin Hospitals and Clinics to test the hypothesis that injection of Botox into the affected muscle group will alleviate pain associated with R-CECS.
Michael Suer
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT05006417
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Inclusion Criteria:

• Willing to provide written informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Documented diagnosis of R-CECS determined with elevated compartmental pressure testing following lower extremity fascia release (fasciotomy or fasciectomy)
• Females of childbearing potential must have a negative urine pregnancy test prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion Criteria:

• History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes
• Known neuromuscular disease
• Known pulmonary disease including but not limited to asthma, pneumonia, or upper respiratory tract infection
• Dysphagia
• Known cardiac disease including but not limited to congestive heart failure, arrhythmia, or history of myocardial infarction
• Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to enrollment
• Currently or have taken in the past medications that affect neuromuscular function, aminoglycosides, muscle relaxants, or other botulinum neurotoxin agents. Currently taking any blood-thinning medications including, but not limited to Plavix, Coumadin, Eliquis, Xarelto
• Women who are pregnant or breast-feeding
• Vulnerable populations
• Not suitable for study participation due to other reasons at the discretion of the investigator
Certain early complications of trauma, Other, Compartment Syndrome of Leg
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Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns

This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).
Angela Gibson
All
18 Years to 75 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04090424
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Inclusion Criteria:
1. Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed 2. Willing to comply with all study procedures and expects to be available for the duration of the study 3. Male and females ≥ 18 years of age and ≤ 75 years of age 4. Patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (TBSA). Types of burns include the following:
• Scalding including from hot water, cooking oil, grease
• Flame
• Flash
• Contact 5. Subjects who have staged surgical procedures planned e.g., one procedure to excise the burn injury and a later procedure to prepare the wound bed and apply an autologous skin graft. 6. The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA 7. Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study.
Exclusion Criteria:
1. Has a known hypersensitivity to polyurethane 2. Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash 3. Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin 4. Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy 5. Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound 6. For females
•has known or suspected pregnancy, planned pregnancy, or during lactation 7. Has exposure to any other investigational agent within the last 6 months 8. Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration 9. Anticipated inability to perform wound care and follow-up procedures 10. Anticipates of a level of non-compliance 11. The use of off-label treatments for full-thickness / deep-dermal burns is not permitted 12. Clinical signs of wound infection at areas to be potentially treated using NovoSorb® BTM that in the opinion of the investigator may compromise safety and study objectives 13. The use of NovoSorb® BTM on the face and in the perineum area is not permitted
Burns, Burns and corrosions of external body surface, Other, Injury, Trauma & Emergency Medicine
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The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)

This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.
Angela Gibson
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04356859
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Inclusion Criteria:

• Age ≥ 18 years
• Total burn size (second and third degree) is ≥ 25% of the TBSA
• Burn center admission within 12 hours of injury.
• There is a plan for formal fluid resuscitation.
Exclusion Criteria:

• Significant associated trauma
• High voltage (≥ 1000 volts) electrical burns
• Burn wound excision surgery within 48 hours from injury
• Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
• Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
• Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury
• High dose Vitamin C infusion given at any time ≤ 48 hours from injury
• Administration of human albumin prior to randomization
• Palliative comfort measures are instituted ≤ 48 hours from injury
• Pregnancy
• Pre-injury chronic renal insufficiency equal to or greater than stage 3
• Pre-injury chronic hepatic disease (Child-Pugh B or C)
• Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)
Burn Injury, Burn of unspecified body region, unspecified degree, Other, Injury, Trauma & Emergency Medicine, Skin & Dermatology
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Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes

This study investigates fluorescence image-guided surgery to allow precise identification of necrotic tissue both preoperatively and intraoperatively in burn patients. Furthermore, it uses a multi-model approach to elucidate the localization of ICG in inflammation and necrosis to determine how this novel use of a well-known fluorescence marker can be optimized to aid in surgical decision making. This proposal will provide the necessary data to support the design of a larger clinical trial to study the feasibility and efficacy of this technology to improve the precision of necrosis detection and removal and improve wound healing outcomes. Up to 100 participants will be on study for up to approximately 24 days.
Angela Gibson
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT05593523
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Inclusion Criteria:

• English speaker
• Patients with partial thickness indeterminate depth burn wounds that occurred within 24 hours of admission and are expected to require admission for at least 3 days (Aim 1) or with deep partial thickness or full thickness burn wounds that are 1-30% TBSA and will likely require surgery (Aim 2)
• Subject understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
Exclusion Criteria:

• Contraindication to Indocyanine Green (ICG) injection, i.e. previous reaction to ICG (adverse event rate: 1 in 42,000) or Iodine allergy.
• Inability to obtain consent
• Subject with pre-existing inflammatory diseases or chronically treated before admission to the hospital with steroids or nonsteroidal anti-inflammatory drugs or biologics
• Subject with immune deficiency (HIV infection or use of corticosteroids, cytostatic drugs, tetracycline and certain bisphosphonates)
• Subject with known or suspected infections or on antibiotic therapy
• Subject known or suspected to be pregnant
Burn Wound, Burn of unspecified body region, unspecified degree, Other, Skin & Dermatology, Injury, Trauma & Emergency Medicine, Surgical Procedures
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