Treatment Trials

22 Clinical Trials for Various Conditions

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COMPLETED
Virtual Reality Analgesia for Pediatric Burn Survivors
Description

Many children with large severe burns report severe pain during burn wound cleaning. The current study explores whether adjunctive immersive Virtual Reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain.

Conditions
TERMINATED
Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient
Description

The purpose of this study is to collect information about how often an abnormal heart beat happens in children who have been burned.

COMPLETED
Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns
Description

The aim of this study is to compare Mepitel Ag to Triple antibiotic ointment impregnated Adaptic gauze when used with the soft cast technique to assess overall time to healing, yeast infection rate and parents perception of pain level at time of dressing change on a scale of 1-10. The hypothesis is that Mepitel Ag in combination with the soft cast technique improves wound healing in pediatric partial to deep partial thickness hand and foot burns by decreasing the length of healing time, decreasing the risk of yeast infection, and decreasing pain associated with dressing changes.

Conditions
COMPLETED
The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients
Description

Adequate sleep is an important aspect of any healing process, and because it is known that children recovering from burns suffer long term sleep disruptions, the investigators believe that Healing Touch may improve the quality and quantity of sleep in the pediatric burn population.

Conditions
COMPLETED
SSD vs Collagenase in Pediatric Burn Patients
Description

The objective of this study is to evaluate the outcomes of children with burn injury with regard to the utilization of Silver sulfadiazine (SSD) cream and Collagenase ointment. The primary outcome variable will be need for skin grafting. The specific aim of the study is to prospectively collect data to determine if SSD is superior to Collagenase with regard to avoiding the need for skin grafting.

Conditions
COMPLETED
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Description

Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

Conditions
COMPLETED
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
Description

The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.

Conditions
COMPLETED
Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors
Description

The purpose of this study is to establish an expected recovery trajectory (recovery model) in terms of physical and psychological function of the pediatric burn patient.

Conditions
TERMINATED
Lactobacillus GG Supplementation During Pediatric Burn Injuries
Description

Critical illness and the therapies that accompany it are associated with a disruption in the ecological equilibrium of the GI tract that can ultimately lead to infection. Lactobacillus GG, a probiotic, replenishes the healthy flora of the intestinal tract and may decrease the risk of diarrhea and infection during critical illness. However, little is known about the impact of probiotics following a burn injury and the mechanisms behind the proposed benefits. The hypothesis of this research is that Lactobacillus GG decreases the incidence of diarrhea and infection in burned children receiving antibiotic therapy. The specific aim of this research is to determine the impact of Lactobacillus GG on the incidence of diarrhea and infection among burned children (\>20% TBSA) receiving antibiotic therapy.

Conditions
TERMINATED
Study of Culturelle in the Prophylaxis of Infection and Diarrhea
Description

The primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients.

Conditions
TERMINATED
The Effect of Selenium Supplementation Among Pediatric Patients With Burns
Description

The selenium status of children with major burns is suboptimal which may increase the incidence of infection. Se requirements during critical illness are not known. Results from this investigation may provide a tool for recommending Se supplements during burn injury. The hypothesis of this research is that Se supplementation will restore the depressed Se status among children with burn injuries. The secondary hypothesis is that Se status is related to the incidence of infection among pediatric patients with burns.

Conditions
WITHDRAWN
Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury
Description

Pediatric patients that sustain partial thickness burn injuries to their extremities require regular scheduled dressings and weekly appointments for better healing. Typically, the dressing used at Children's Hospital of Michigan is Xeroform, which can often be painful when changing at the weekly clinic appointment. Mepilex Ag is also an approved treatment for these types of burns and has the potential to cause less pain with dressing changes, however is not used as frequently due to a much higher cost. Studies evaluating the treatment of partial thickness burns in pediatric patients have shown decreased cost and length of stay associated with dressings that are silver impregnated, like Mepilex Ag. However, these studies are all retrospective with a possible selection bias to patients. In addition, several studies have suggested less pain with newer foam and hydrofiber dressings. We are conducting a prospective study using patients with partial thickness burns of their extremities, applying Xeroform on half of the burn, and Mepilex Ag on the other half of the burn, to remove confounding variables between patients to determine the optimal burn dressing for partial thickness scald burns for pediatric patients. A partial thickness burn, also known as a second degree burn, extends into the top two layers of the skin, not passing the hypodermis. Our goal is to determine if Xeroform or Mepilex Ag is superior treatment for partial thickness burns in pediatric patients for healing time, appearance of scar, and patient pain and comfort during treatment and dressing changes.

ENROLLING_BY_INVITATION
VR-PAT During Home Burn Dressings - Multisite
Description

This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.

COMPLETED
StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
Description

Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns. It works to close the wound, but can cause other problems: * Donor sites are painful, can become infected or scarred, or can even become full thickness (FT) wounds themselves * Treatment problems can require more grafting * Additional surgery increases the risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective alternative to autografting to promote the healing of severe burns. The purpose of this study was to evaluate whether StrataGraft treatment eliminates or reduces the need for autografting and promotes wound closure in a pediatric population with thermal burns that contain intact dermal elements and for which autografting is clinically indicated (DPT burns). Participants were enrolled into one of two age-based cohorts: 2 to \< 12 years and 12 to ≤ 17 years to receive a single application of StrataGraft, in up to 3 non-contiguous DPT burn areas located on the same extremity or plane of the torso.

COMPLETED
Telemedicine Optimized Burn Intervention
Description

Because burn patients and their caregivers often live long distances from regional burn centers, access to expert burn care is limited, resulting in a negative effect on adherence to treatment and a higher risk of wound complication. A novel smartphone application synchronized with a web portal for providers, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging, image transfer, and video-conferencing. The goal of the present study is evaluate TOBI compared to face-to-face care as usual for pediatric patients/caregivers visiting a burn center. This study will also assess the feasibility of conducting a larger-scale clinical trial in several burn centers. The app will allow the physician and patient to make instant decisions regarding treatment, allowing for "turn on a dime" treatment decisions, rather than having the patients and families wait for scheduled clinic appointments, often hours away from home. This "on demand" medical care takes an innovative approach to increasing access to burn experts through smartphone technology and addressing adherence to prescribed treatment by increasing communication between provider and patients.

COMPLETED
Opioid Laws and Pediatric Use
Description

The legitimate need for opioid medications for acute pain management in pediatric trauma patients is recognized, however, the high dose and duration of opioid drugs prescribed by medical providers has been associated with an increased risk of opioid abuse and chronic use by patients. The overarching goal of application is to assess opioid use and outcomes of pediatric patients treated for either burn injuries or knee arthroscopy procedures at a large academic pediatric medical center before and after Ohio opioid prescription rules for acute pain were implemented on August 21, 2017. Also, to evaluate patient use of opioids at 90-days post-treatment.

TERMINATED
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
Description

A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a standardized wound dressing.

Conditions
UNKNOWN
Laser Therapy for Treating Hypertrophic Burn Scars in Children
Description

Pulse-dye laser therapy has been used to treat the redness, tightness and discomfort of hypertrophic scars resulting from burn injuries. To date the effectiveness of laser therapy on children's burned scars has not been measured.

Conditions
COMPLETED
Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients
Description

The purpose of this study is to determine whether either a peripheral nerve block under ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s guided block of the nerve followed by continuous catheter infusion of local anesthetic, offers better post-operative analgesia in pediatric burn patients undergoing reconstructive surgery, than the current analgesic regimen of subcutaneous local anesthetic infiltration. Eligible subject, pediatric patients having reconstructive surgery for burns, having skin graft donor sites of the lateral thighs, will be randomized into three groups: control (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided nerve block with catheter placement --fascia iliac. Post-operative comfort will be assessed over the next 48 hours.

Conditions
COMPLETED
Virtual Reality Analgesia During Pediatric Physical Therapy
Description

We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).

Conditions
WITHDRAWN
Quantification and Derivation of Metabolic Needs in Children During Burn Rehabilitation
Description

The investigators are collecting information on the calorie needs of patients in the first year postburn. The investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury.

Conditions
NOT_YET_RECRUITING
VR-PAT and fNIRS to Identify CNS Biomarkers of Pain
Description

This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).