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Pressure Ulcer clinical trials

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NCT ID: NCT02055729 Completed - Bedsore Clinical Trials

Changes in Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study

EscaFlor
Start date: May 11, 2015
Phase:
Study type: Observational

The main objective of this study is to characterize the evolution (over a period of 28 days) of superficial and deep bacterial skin flora in patients with stage 3 or 4 sacral pressure ulcers (bedsores). Changes in terms of pathogenic, potentially pathogenic and non-pathogenic bacterial species at the intra-individual and population levels.

NCT ID: NCT02020655 Completed - Clinical trials for Pressure Ulcers, Bedsores, Decubitus Ulcer

Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin

Start date: November 2014
Phase: N/A
Study type: Observational

Background: A pressure ulcer is localized tissue injury to the superficial layer of the skin and/ or the underlying tissue. Pressure ulcers are most likely to develop in skin areas exposed to pressure, shear and friction. Shear- force is an important contributing factor and wound dressing are possibly capable to reduce shear force at the skin. At this moment there's no good marker to detect the effect of shear- force at the skin. A potential marker could be cytokines (IL-1α) which are released after mechanical loading of the skin. A previous study have shown a significant increased level of IL-1α after the application of pressure. We want to investigate if these cytokines are significant increased after the application of shear- force at the skin. Objective: The objective of this study is to gather knowledge about cytokine concentrations (IL-1 α) in the skin of healthy volunteers after the application of shear- force. We want to use this knowledge in the future to investigate if different prophylactic wound dressings are capable to reduce shear force at the skin. This could be interesting in the prevention of pressure ulcers. Study design: With the use of a special developed shear- force model are we going to administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy volunteers for 30 minutes. As a control we ware going to put the shear- force model at the other arm without the application of shear- force. Before the use of the shear- force model we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb cytokines from the skin. After the use of the shear force- model we will perform cytokine measurements again. Then we will extract the cytokines from the Sebutape with the use of ELISA. Study population: 10 Healthy volunteers Age 18- 30 years Primary outcome: IL-1 α concentration (pg/ml)

NCT ID: NCT02008487 Completed - Pressure Ulcer Clinical Trials

Wound Powder for Pressure Ulcers at End-of-life

RGN107
Start date: April 2013
Phase: N/A
Study type: Interventional

This study will test a special powder for ulcers caused by a variety of conditions such as pressure that sometimes happen when a person is at the end of life. The powder will be applied to these ulcers to see if it helps with pain, odor and drainage (leakage). People who are being cared for by hospice or palliative care organizations will be invited to be in the study. The study will also find out if the powder is easy to use by caregivers as well as improving the comfort and quality of life of the person who has the ulcer.

NCT ID: NCT02007824 Completed - Pressure Ulcer Clinical Trials

Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

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

Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.

NCT ID: NCT02005692 Completed - Pressure Ulcers Clinical Trials

A Pilot Study to Assess the DynaSense System

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

The study is designed to test the DynaSense system, which is a patient movement and orientation monitoring system. The study is intended to determine that: - the DynaSense system identifies patients that are not turning adequately on their own and therefore require caregiver-assisted turns. - the DynaSense system identifies patients that are turning adequately on their own and therefore do not require a caregiver-assisted turn. - the DynaSense system helps ensure compliance with an institution's established patient turning protocol.

NCT ID: NCT02001558 Completed - Clinical trials for Spinal Cord Injuries

Pressure Ulcer Healing With Microcyn

Start date: March 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to test how well Microcyn™ works on Stage 3 and Stage 4 pressure ulcers compared to sterile saline among persons with spinal cord injury.

NCT ID: NCT01999816 Completed - Clinical trials for Spinal Cord Injuries

Pressure Ulcer Prevention Study in SCI

PUPS
Start date: September 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the intervention's cost-effectiveness and potential cost savings and its effects on participants' quality of life.

NCT ID: NCT01965444 Completed - Pressure Ulcers Clinical Trials

A Test of the Investigational SEM Scanner

Start date: September 2013
Phase: N/A
Study type: Observational

The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. This will help with clinical interpretation of the numbers and readings this device will provide.

NCT ID: NCT01943201 Completed - Spinal Cord Injury Clinical Trials

Low Friction Bed Sheet

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

Introduction: It is known that people with spinal cord injury (SCI) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. It was the aim of the study to examine the effects of a specially developed low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients with SCI. Method: Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be recruited. Each patient spends five consecutive nights on the new, respectively, conventional bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS) concerning well-being, odour, perspiration and wrinkling. In addition, the patients are examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin blood circulation in the parasacral region.

NCT ID: NCT01885962 Completed - Spinal Cord Injury Clinical Trials

Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers

iSHIFTup
Start date: May 2012
Phase: N/A
Study type: Interventional

The investigators propose to test the feasibility of iSHIFTup (Internet Skin Health Intervention For Targeted Ulcer Prevention) for adults with spinal cord injury (SCI) to prevent serious pressure ulcers (PrUs) and promote protective health behaviors. This protocol is Phase 2 of a three phase project. In Phase 1, the investigators developed iSHIFTup. In Phase 2, the investigators will test the intervention by partnering with Woodrow Wilson Rehabilitation Center (WWRC) to conduct a randomized controlled trial (RCT) of 18 participants. In Phase 3, the investigators will focus on optimizing the intervention based on our outcome findings and feedback, sustaining the program at WWRC, and seeking future funding for a larger RCT. The investigators will conduct an RCT of up to 18 participants (9 participants in treatment as usual (TAU) group, 9 participants in TAU + iSHIFTup intervention group) (18 participants are needed to obtain statistically significant results). The investigators will meet with potential participants in-person to complete the informed consent process and confirm eligibility. Participants in the TAU+iSHIFTup group will use the program during the study period. Participants randomized to TAU will have usual treatment during the study period and an opportunity to use the program following trial participation. The investigators will collect information from participants at two times during the study, at enrollment and post-intervention at 6-weeks (42 days). The investigators will also collect qualitative information from participants in the TAU+iSHIFTup group, during an optional focus-group setting, to learn users' experiences with the program. The investigators expect participants in the TAU+iSHIFTup group as compared to the TAU group, to display greater awareness of personal risk for pressure ulcers; increased preventive behaviors; and increased skin care self-efficacy and knowledge.