622 Clinical Trials for Various Conditions
This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.
This is a randomized controlled trial. Patients will be randomly assigned to either the control or treatment group, with equal allocation using block randomization. The primary null hypothesis is that a combination sufentanil and buprenorphine based pain control regimen will not result in lower morphine equivalent requirements for pain control when compared to a classic fentanyl and hydromorphone based regimen. The secondary working hypothesis is that the patient satisfaction survey mean satisfaction scores will be higher in the buprenorphine and sufentanil treated group when compared to the classic fentanyl and hydropmorphone treated group. The secondary null hypothesis is that the patient satisfaction surveys mean scores will not be significantly different in the buprenorphine and sufentanil treated group when compared to the classic fentanyl and hydropmorphone treated group. The tertiary working hypothesis is that the patients will have significantly lower rates of relapse as defined by follow up with their home suboxone clinic at 2 and 4 weeks. The tertiary null hypothesis is that patients have equivalent rates of relapse as defined by follow up with their home suboxone clinic at 2 and 4 weeks.
The primary purpose of this study is to determine the feasibility and preliminary efficacy of a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma surgery patients (compared to an active control group that receives digital health education). Aim 1: Determine feasibility of and satisfaction, and perceived utility of "My Surgical Success" Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the study (feasibility). Of those who complete My Surgical Success, the investigators expect 80% satisfaction ratings, and 80% perceived utility of the information learned. Aim 2: Determine group differences in time to post-surgical pain and opioid cessation. Hypothesis 2: "My Surgical Success" participants will evidence quicker time to post-surgical pain and opioid cessation compared to the HE Control Group. Aim 3: Determine group differences in within-subject pain catastrophizing scores (baseline to post-surgery). Hypothesis 3: "My Surgical Success" participants evidence greater reduction in pain catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE Control group. Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Social Isolation, Fatigue, and Pain Intensity). Hypothesis 4: "My Surgical Success" participants will evidence greater post-surgical function and lower pain related interference compared to the HE Control Group. The goal of this research is to advance our understanding regarding the feasibility and effectiveness of "My Surgical Success" (a digital, perioperative behavioral pain medicine treatment) and its impact on post-surgical outcomes.
This is a phase I, randomized, single-blind, placebo-controlled, single-center study of the effects of surgical site injection on pain and narcotic utilization in participants who undergo surgery for lower extremity fractures. 200 participants with lower extremity fractures who are admitted for operative fixation will be included in the study. Participants will be randomized to receive either a pain cocktail injection around the fracture site and surrounding tissues or control (no injection). An analysis of pain scores, rehabilitation progress, length of stay, narcotic utilization, and satisfaction scores will be performed.
Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (\>300mL) is expected. The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.
This study proposes to develop a computer-based software tool that will allow surgeons to plan and simulate surgery for patients with jaw trauma.
The goal of this clinical trial is to learn whether a single dose of ketamine during surgery can help lower pain, reduce the need for opioid medications, and improve mental health recovery in adults with serious orthopedic injuries. The main questions it aims to answer are: Does ketamine lower pain after surgery? Does ketamine help reduce how much opioid medicine participants need? Does ketamine improve symptoms of depression and post-traumatic stress disorder (PTSD)? Researchers will compare participants who receive ketamine during surgery to those who receive standard anesthesia without ketamine. Participants will: Receive either ketamine or standard anesthesia during surgery Answer survey questions about pain, depression, and PTSD at several points after surgery (from a few days up to 6 months) Be followed by the research team through clinic visits and phone calls
This is a randomized controlled trial which is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.
The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are: 1. Surgical site infection rates 2. Patient quality of life 3. Time to wound healing Participants will undergo either complete ostomy wound closure after washing out the wound with Prontosan, or their ostomy wound will be closed using the Pursestring method, where the wound will be left partially open and allowed to heal from the inside out. Researchers will compare these two groups' outcomes (questions to be answered) as listed above.
The DROP trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. The current standard of care at Sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. In this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. This trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner
Many surgical site infections are caused by bacteria that is transferred from a patient's nose to their open surgical wound. Some small studies have shown that putting povidone-iodine in a patient's nose reduces this risk. This study aims to evaluate the real-world effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University of Iowa.
The purpose of this study is to compare two biologic methods for the treatment of articular cartilage defects in the knee. The first method, microfracture, is the standard of care and is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage loss. The second method is the application of adipose-derived stem cells (ADSCs) to the defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more specific progenitor cells to the site of injury, resulting in better regeneration and integration of articular cartilage at the site of a defect as compared to the microfracture method.
The purpose of this study is to determine the effects of modifiable risk factors on patient-reported quality of life, physical activity levels, and risk of early osteoarthritis following revision anterior cruciate ligament (ACL) reconstruction. The investigators hypothesize that modifiable variables exist at the time of revision ACL reconstruction (e.g., cause of failure, current graft source and type, surgical exposure, and femoral and tibial tunnel position) which will be predictors of patient-reported outcomes.
In this study we will examine patients who have undergone unilateral ACL reconstruction surgery to determine which structural and functional characteristics of the knee two and ten years post reconstruction surgery, aspects of the original injury and repair, and patient characteristics are risk factors for osteoarthritis after ACL reconstruction surgery.
The purpose of this study is to determine the effect of modifiable risk factors on knee function, osteoarthritis, and re-rupture of the anterior cruciate ligament (ACL) following ACL reconstruction.
The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs micrographic surgery (MMS) compared to control.
When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. The most commonly performed closure technique uses running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches. However, alternative closure techniques exist such as the running locking suture, which can offer advantages such as improved tension and thus reduce post-operative complications with better aesthetic outcome. In this study, half the wound will be stitched with standard running sutures and the other half will be stitched with running locking sutures. This will allow us to see if the side with running locking sutures heals with less scarring.
This is a single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds. Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.
When patients have surgery on the neck, trunk, arms, or legs, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. One idea is to reduce the tension around the cut. One way to reduce tension is to free up the skin around the wound. This procedure is also called "undermining". Some studies have shown that freeing up the skin near the tips of the wound, called the "apices," is helpful for improving the cosmetic outcome of scars. This study will investigate if there are any differences in the appearances of the scar if one tip is undermined and the other is not.
When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. One idea is to reduce the tension around the cut. One way to reduce tension is to stitch a small piece of a special gauze over the top of the regular stitches. This procedure is called a "tie-over bolster dressing." As the name implies, this extra dressing "bolsters" the wound closure so that the skin on each side of the cut stays in place. The bolster dressing procedure has been used in the past in special cases, such as when skin grafts are necessary. The bolster dressing helps the skin graft heal by making sure the graft stays exactly in place. Keeping the wound stable with a bolster dressing also reduces bleeding under the wound. For non-grafted wounds, the bolster dressing procedure has not normally been used, and has not been well-studied. In this study the whole wound will be stitched normally and then the bolster dressing will be applied over half of the wound. This will allow us to see if the side with the bolster dressing heals with less scarring.
This study is trying to find out if there is one method of surgical incision closure is better than another. The three different wound closure methods in this study are currently used in standard of care. The three methods being compared are standard stitches and the wound closure devices, Clozex, and Zipline. All of these methods are approved by the FDA.
The purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction. This is a randomized clinical trial. Approximately 32 participants who are undergoing nasal tip wound reconstruction surgery will be invited to participate and randomized to receive either the nasalis sling repair or the lobed flap repair. Patients will be asked to complete a few questionnaires including a VAS scale, the Surgical Outcomes scale, the NOSE instrument, and the Nasal Appearance and Function Evaluation Questionnaire (NAFEQ). This study was a pilot study designed to determine the feasibility of these procedures.
Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery. Standard skin preparations have been found to be ineffective at eradicating C. acnes colonization on the skin and deep dermis of patients undergoing surgery. Recent literature has shown that skin preparation with 3% hydrogen peroxide solution is effective for decreasing the rate of cultures positive for C. acnes in both dermal and deep cultures; however, a positive rate of 10%-17% has still been reported despite this skin preparations. The current theory is that standard skin preparation does not remove C. acnes from the deep dermis which subsequently contaminates the deep tissue. We hypothesize that application of 3% hydrogen peroxide to the deep dermal layer immediately following the skin incision will even further decrease the rate of C. acnes contamination during surgery.
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
This clinical study is to evaluate a novel biomarker - CNA Rapid Sepsis Dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. Using circulating cell-free DNA (cfDNA) in the blood stream, it has been demonstrated to detect infection response days before clinical evidence of sepsis manifests. The hypothesis is that blood biomarkers drawn daily in the hospital will identify patients who develop sepsis within seven days of hospital presentation.
This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.
The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.
Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. The investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. If participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. The other half of the wound will be closed with non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.
Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persist for years despite rehabilitation, hindering resumption of normal activities, increasing risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). Our goal in this research study is to evaluate the utility of neuromuscular electrical stimulation (NMES), initiated following injury and maintained through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active control intervention of micro-electrical stimulation.