View clinical trials related to Wounds.
Filter by:The study's aim is to determine whether use of a mechanical device can improve the timeliness of anesthesia provided by liposomal lidocaine cream. Liposomal lidocaine cream has historically come in the brandnames of ELA-Max and LMX, with either 4% or 5% lidocaine in the cream. In this protocol, the abbreviation LLC will be generally used to refer to the 4% concentration to be used in FAST Lidocaine. Regardless of the concentration used, the encapsulation of lidocaine in liposomes protects the anesthetic from rapid metabolism and allows the medication to remain in the epidermis, yielding a theoretical benefit of long-lasting anesthesia.1 The test device is a painless functional microarray (FMA) that renders hundreds of microscopic punctures per cm2 in a patient's stratum corneum. The holes in the stratum corneum subsequently allow for faster movement of LLC into the skin to be anesthetized. Currently, topical anesthetics are used less commonly in the Emergency Department (ED) than would be the case if the available approaches were not associated with such long onset times. The most commonly utilized topical anesthetic for intact skin, eutectic mixture of local anesthetics (EMLA), requires at least an hour for anesthetic effect; maximal effect requires up to 2 hours.2, 3 4 The topical anesthetic to be used in the FAST Lidocaine study, 4% LLC, has a roughly equipotent analgesic effect to that of EMLA and works faster, but must still be in place for at least a half-hour before onset of reliable anesthesia.1, 5-8 Commentators have judged such delays "considerable" and written that because of long application times, use of topical anesthetics may not be practical.1, 8-10 In discussing agents (such as LLC) that are formulated for more rapid transcutaneous absorption, ED wound care experts have written that "their delayed onset limits their use in the emergent setting."11 It has also been noted that LLC's utility is potentially diminished by the fact that anesthesia may begin to wear off as soon as 10 minutes after cream removal.8 Given the previously outlined findings, it is obvious that there is room for improvement in ED delivery of topical anesthesia. The goal of rendering topical anesthesia practical - and thus more likely to be used - constitutes the basis for the FAST Lidocaine study. We seek to identify whether a novel approach safely and painlessly improves the onset time (and perhaps depth) of topical anesthesia. Reducing pain caused by procedures involving violation of the skin barrier (e.g. intravenous [IV] line placement, anesthesia and suturing of wounds) is an important goal. Needlesticks and IV catheters have been identified as important causes of pain in both children and adults.8, 12, 13 In terms of frequency, U.S. EDs place over 20 million IV catheters and care for over 10 million wounds.9 Thus, there is potentially broad-based utility in a potentiator for local anesthesia absorption in the ED. The importance of the clinical goal of improving absorption of topical anesthesia has already prompted efforts aimed at improving delivery and efficacy of topically applied local anesthetics. Previous investigations have demonstrated utility - and limitations - of various methods of traversing and/or stripping the stratum corneum. Among the techniques studied have been use of electrical energy (iontophoresis),14 sound waves (sonophoresis),15, 16 adhesive tape17-19 and lasers.11, 12, 20, 21 While these varying approaches all have promise, their limitations leave room for assessment of a new method if it promises to be safe, painless, and effective. The approach of the FAST Lidocaine study will be to assess FMA use. The FMA is a painless mechanism that is placed on the skin with minimal pressure. It creates microscopic punctures in the stratum corneum, facilitating movement of anesthetic through the cutaneous barrier. The device's physical characteristics, namely its easy application and low apparent potential for incorrect or unsafe use, appear quite suitable for ED utilization. If it works, the FMA would be immediately useful in a variety of circumstances. The overarching goal of the FAST Lidocaine investigators is to assess whether the FMA can improve management of procedure-related pain in the ED. The main problem in terms of ED use of the currently available topical anesthetics - whether EMLA, LMX, or others - is the time of onset, rather than anesthetic efficacy. Thus, it is the timing impracticality for most ED situations that is the spur for FAST Lidocaine. The study's primary focus and endpoint will be time to anesthesia. Secondary analysis will evaluate whether the depth of anesthesia is improved by assessing the nadir of visual analog scale (VAS) assessments. However, it is noteworthy that deeper anesthesia is not necessary in order to establish the potential utility of FMA in the acute care setting.
The investigators have developed a new non-invasive medical device called the Bioelectric Field Imager. They plan to use this device to measure the electric field near small lancet wounds in 60 volunteers. Their hypothesis is that the electric field is an early stimulus for wound healing and the magnitude of this field will vary with wound healing capability. The investigators will compare the electric fields near arm and leg wounds in males and females in the age groups of 18-30 and 65-80. In addition they will measure these wound fields in diabetics and near chronic ulcers.
The purpose of this study is to determine: 1. If vacuum assisted closure (VAC®) therapy results in altered proteomic expression of angiogenic markers compared to moist wound therapy. 2. If VAC® therapy results in increased angiogenesis compared to moist wound therapy.
The purpose of this study is to determine if a new antimicrobial gauze dressing is better than the current method of dressing open wounds with plain sterile gauze. It is hoped that the antimicrobial gauze will reduce the number of germs in the open wound and even improve the rate of healing.
Comparison of wound healing treatments; platelet gel vs. control
The goal of this project is to pilot-test an instrument that is designed to assess the relationship between persons who use controlling behavior with intimate partners, as a risk factor for perpetrating intimate partner violence, and workplace productivity. The goal is to validate a survey instrument that can be applied to other workplace settings to measure productivity losses associated with controlling and aggressive behavior, which will serve to inform the development of workplace interventions designed to prevent intimate partner violence (IPV). This pilot-test will include two components of a survey conducted with employees in a workplace setting: questions to determine one’s controlling behavior or propensity for violence in an intimate relationship, and questions designed to assess levels of productivity as measured by days missed from work (absenteeism) and days at work with diminished functional output (presenteeism). We expect productivity to decrease as one’s controlling behavior or propensity for perpetrating IPV increases. This study represents one of the first workplace surveys designed to measure workplace productivity as a function of controlling or violent behavior. Successful results would argue for a more wide-scale testing of the instrument, which could ultimately lead to the development of workplace interventions designed to prevent IPV.
This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.
The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC) versus standard wet to dry dressing in treating lower leg fasciotomies.
SACCHACHITIN gel, prepared from the waste residue of the fruiting body of Ganoderma tsugae, was used in a previous study to enhance skin wound healing in animal models. In the present study, the effects of the gel on the activity of matrix metalloproteinases (MMPs) and vascular endothelial growth factor (VEGF) as well as on the healing of skin wounds in humans are estimated by a clinical trial. The hypothesis regarding the poor healing of the wound is the over-expression of MMP and the inhibition of the angiogenic factors. From the previous animal study, the effect of SACCHACHITIN was to inhibit the activity of MMP and stimulation of VEGF and we try to prove the effect over the human wounds from this clinical trial. Patients with a poorly healed wound, in which skin graft is clinically indicated, are included in this study. The exudates from the wound are collected and analyzed for the activity and concentration of VEGF and MMP. The change of the healing process is recorded. Positive results are expected from the clinical trial and the patients will get another choice for the treatment of the chronic wound other than skin grafting.