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Burns clinical trials

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NCT ID: NCT01858753 Terminated - Clinical trials for Restrictive Burn Scars

Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to determine whether injection of autologous fibroblasts can increase the mobility (decrease the restriction) of burn scars. The study will assess the effects of azficel-T (autologous fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either: 1. An axillary scar causing 20-60% restriction of shoulder adduction 2. An anterior elbow scar causing 20-60% restriction of elbow extension 3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7 days) apart (depending on cell availability) and will be followed for efficacy (including range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for safety to Visit 9 at 1 year.

NCT ID: NCT01843686 Active, not recruiting - Acute Burns Clinical Trials

Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns

Start date: April 2013
Phase: Phase 1
Study type: Interventional

This study will demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. The study will be a randomized, double-blinded controlled safety study. Investigators expect that the PRP will deliver improved hemostasis and growth factors at the wound site thus increasing the effectiveness of treatment at the wound site. This will lead to rapid production and delivery of an autologous therapy that should minimize additional morbidity to the patient.

NCT ID: NCT01828541 Active, not recruiting - Burns Clinical Trials

Hypnosis for Pain and Itch Following Burn Injuries

Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether hypnosis will decrease the intensity of either pain or itch in patients who have sustained a burn injury. Primary hypothesis: Hypnosis will provide more effective relief from post-burn itch and pain than a control intervention at 1-month, 3-months, 6-months and 1-year post-burn injury. Secondary hypothesis 1: Subjects treated with hypnosis will report better sleep quality and fewer symptoms of Post Traumatic Stress Disorder (PTSD). Secondary Hypothesis 2: Subjects treated with hypnosis will require less escalation of the gabapentin doses and have lower average pain scores than those in the control group. Exploratory Hypothesis: Subjects who will randomize to the hypnosis treatment group early after injury will report lower rates of neuropathic pain and itch than subjects who will be enrolled in the study and receive hypnosis later in the healing process.

NCT ID: NCT01812941 Recruiting - Trauma Clinical Trials

Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients

Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers. Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients. As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial dysfunction.

NCT ID: NCT01812655 Terminated - Pain Clinical Trials

Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents

Start date: June 2010
Phase: N/A
Study type: Interventional

Relief of severe burn wound care pain may require both medications to relieve pain and non−medication interventions,such as distraction. Little is known about distraction's effectiveness. Virtual reality may be an effective distraction. The aims of this study are 1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction, compared to passive distraction (PD) by watching a movie, and usual care (SC) that is provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to determine the relationship among anxiety, desire for distraction, and engagement with distraction on the pain.

NCT ID: NCT01795079 Completed - Chronic Pain Clinical Trials

Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury

Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation. If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

NCT ID: NCT01790763 Withdrawn - Clinical trials for Skin Burn Degree Second

Compare the Efficacy of Mepilex and Keramatrix in Second Degree Burn Wounds

Start date: April 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients.

NCT ID: NCT01785784 Completed - Clinical trials for Deep Partial Thickness Burn

Efficacy and Safety Study of rhGM-CSF Gel to Treat Deep 2nd Thickness Burn

rhGM-CSF
Start date: November 2010
Phase: Phase 4
Study type: Interventional

This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for Topical Application (rhGM-CSF Gel) on deep 2nd burn. There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized, reference controlled study, all the subjects were randomized into two groups, test group (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were enrolled in reference control group. In the test group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, spread the test drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product every two or one day according to the effusion. In the reference control group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, bandaging with iodophor gauze, change the drug product every two or one day according to the effusion. Whole treatment were lasted till the wound surface was healing completely, if it is not recovered in 4 weeks, calculate and record the healing rate. The secondary part of the study was a multicenter, open study, to investigate the safety of rhGM-CSF on deep 2nd burn patients. Totally 2329 patients were enrolled in this part of the study.

NCT ID: NCT01754740 Completed - Clinical trials for Burning Mouth Syndrome

The Role of Xerostomia in Burning Mouth Syndrome: Case - Control Study

BMS
Start date: January 2010
Phase: N/A
Study type: Interventional

Objectives: to evaluate xerostomia and salivary flow in patients with burning mouth syndrome (BMS) treated with amitriptyline before and after the use of antixerostomic topical medication. Methods: In this case-control double-blinded study, we enrolled 38 patients with BMS diagnosed according to the (IASP). The subjects were randomly divided into two groups: Study Group: 19 patients whom received topical medication of urea 10% and Control Group: 19 patients whom received placebo to apply at the oral cavity 3-4 times per day, during three months. The patients were evaluated before and after the above treatment. Finally, data were statistically analyzed. It is know that BMS is eventually associated to reduced salivary flow (Cho et al.,2010; Kho et al., 2010; Marino et al., 2010) and to abnormal salivary composition (increasing concentrations of K+, Na+, Cl-, Ca+2, IgA, amylase) (Patton et al., 2007). Even in the absence of hyposalivation, patients may complain of xerostomia and dry mouth (Cho et al.,2010; Kho et al., 2010; Marino et al., 2010; Thomson, 2005). These patients also have several sensory losses even in taste and smell function, recently described (Siqueira et al., 2006a; Siqueira et al., 2006b; Siviero et al., 2011).

NCT ID: NCT01750034 Withdrawn - Burns Clinical Trials

Best Method of Burn Wound Care: A Prospective Randomized Trial

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to better understand how to best care for burn wounds.