View clinical trials related to Lacerations.
Filter by:This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS). Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research
The PROP(ofol)-study (EU CT number: 2022-502292-39-00, protocol number: ) is a clinical trial phase IV single centre prospective randomized controlled trial with parallel groups. A total of 80 women who undergoes examination and repair of obstetric perineal lacerations (grade I and II) are randomized into two arms (1:1); analgesia with pudendal nerve block (PNB) with ropivacaine (clinical routine, control group), or analgesia with PNB in combination with patient-controlled sedation with propofol (PCS, PCS group). The hypothesis is that PNB in combination with PCS improves patient experienced pain/discomfort during the examination and repair of the perineal laceration. The primary endpoint is patient experienced pain/discomfort. Secondary endpoints are time of repairing the perineal laceration, ability to have skin-to-skin contact with the baby during perineal repair, time until micturition after the perineal repair, procedure feasibility, amount of drugs used during perineal repair, and use of pain relief 24h postpartum. The study is planned to start during the second half of 2023 and end during the first half of 2024.
Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine) to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. Based on previous studies and medication pharmacokinetics, we hypothesize that Intranasal Ketamine will have the shortest Emergency Department (ED) stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.
The overall purpose of this proposed study is the understanding of cellular mechanisms involved in the pathologic fatty degeneration of muscle. Fatty infiltration in skeletal muscle is observed following sports injuries such as muscle strain injuries and Achilles tendon rupture. It is also observed in the degenerative state after rotator cuff tears as well as in the aging process. While fatty degeneration of skeletal muscle occurs in many different conditions and is known to decrease muscle function, the cellular processes involved in fatty infiltration have not been investigated in human muscle. Hypotheses: 1. There is a high amount of fibro-adipogenic progenitors (FAPs) with an adipogenic pattern in pathologic skeletal muscle following a muscle strain injury and a full Achilles tendon rupture. We hypothesize that there is an increased number of FAPs with an adipogenic signature already in the acute phase after a strain injury, but a significantly higher number in the chronic stage as well as in the muscle following an Achilles tendon rupture. 2. Mechanical cues are a major driver of the phenotypic drift of FAPs. The lack of mechanical stimuli initiates the adoption of an adipogenic pathway in naïve FAPs, whereas naïve FAPs exposed to mechanical stimuli will maintain their undifferentiated phenotype. 3. The adherence of FAPs to a soft material will activate the adoption of an adipogenic phenotype, whereas a stiff material will favor a more fibrotic phenotype in naïve FAP's isolated from healthy skeletal muscle.
Background: Replacing a valve in the heart can save many people s lives. The procedure is called transcatheter aortic valve replacement (TAVR). In rare cases, a flap of tissue called a leaflet can shift during TAVR; the leaflet may block blood flow to the coronary arteries, which supply blood to the heart muscle. About 50% of people who experience this problem will die. To reduce this risk, doctors will cut this leaflet during TAVR. But the tools used to cut the leaflet were originally designed for other purposes. Using these tools during TAVR can be complicated and risky. Researchers want to make TAVR safer. Objective: To test a new device (TELLTALE) designed specifically for use during TAVR. Eligibility: People aged 21 years and older who are undergoing TAVR and who are at high risk of coronary artery obstruction. Design: Participants will be screened. They will have routine tests that are done before undergoing TAVR. Before the procedure, participants will complete a questionnaire. They will talk about how their heart disease affects their quality of life. Their physical abilities and their risk of stroke will be assessed. Participants will be admitted to the hospital for TAVR. They will be placed under general anesthesia or moderate sedation. The procedure will be performed using the TELLTALE guidewire system. Participants will repeat the tests of their physical abilities after the procedure. They will also repeat the questionnaire about their quality of life. These will be repeated again at a follow-up visit in 30 days. Participants will have a final study visit after 90 days. This visit may be in person or remote....
This is a 3-arm adaptive clinical trial to the optimal light sedative for reducing distress during laceration repair in children. The investigators will compare intranasal (IN) dexmedetomidine, IN midazolam, and nitrous oxide (N20). The primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R).
Comparison of intra-articular administration of synovial fluid-derived mesenchymal stem cells-derived exosomes with synovial fluid-derived mesenchymal stem cells on the same patient.
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation [SCS] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 12 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy. Participating subjects will be randomly assigned to one of two treatment groups: 1. Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation. 2. Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation [SCS]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation). For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm. At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 12 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.