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Pressure Ulcer clinical trials

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NCT ID: NCT01211236 Completed - Pressure Ulcers Clinical Trials

Maggot Therapy for Wound Debridement

MAGGOT
Start date: February 2006
Phase: Phase 3
Study type: Interventional

The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´ hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.

NCT ID: NCT01139879 Completed - Pressure Ulcers Clinical Trials

P400 for Stage II-IV Pressure Ulcers in Home and Extended Care

P400
Start date: June 2010
Phase: N/A
Study type: Interventional

To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home) environment.

NCT ID: NCT01107197 Completed - Pressure Ulcers Clinical Trials

Nutritional Support in Pressure Ulcer Patients

OEST
Start date: February 2010
Phase: N/A
Study type: Interventional

Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. Moreover, other investigators have suggested the additional healing power of some nutrients. Unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. The investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.

NCT ID: NCT01090076 Completed - Pressure Ulcer Clinical Trials

The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates- A Placebo Controlled Trial

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

This research aims to address the gap in the studies done and test the effects of a commercial mixture of 7 g of Arginine, 7 g Glutamine and 1.2 g HMB* twice a day on hard to heal pressure ulcers in an Asian patient cohort in an acute healthcare setting.

NCT ID: NCT01022216 Completed - Wound Healing Clinical Trials

Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.

NCT ID: NCT01008254 Completed - Pressure Ulcers Clinical Trials

Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers

TEAM
Start date: September 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers.

NCT ID: NCT00971048 Completed - Clinical trials for Diabetic Foot Ulcers

Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds

Start date: September 2009
Phase: N/A
Study type: Interventional

To compare HP828-101 to standard of care for the management of partial or full thickness wounds

NCT ID: NCT00847665 Completed - Pressure Ulcers Clinical Trials

Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens

PUPPAS
Start date: February 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare a 2-hour versus every 4-hour turning regimen on the incidence of grade > II pressure ulcers (PU) in patients in ICU on mechanical ventilation ≥ 24h that use alternating-pressure air mattresses (APAMs).

NCT ID: NCT00796042 Completed - Pressure Ulcer Clinical Trials

Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study

WOUND
Start date: January 2008
Phase: Phase 3
Study type: Interventional

People with spinal cord injuries posses many factors that increase their risk of developing pressure ulcers. Not surprisingly, approximately 82% of persons with spinal cord injury (SCI) will experience a pressure ulcer at sometime during their life. Earlier guidelines for the assessment and treatment of pressure ulcers produced by RNAO in 20027 recommended that "a client who has a pressure ulcer on a seating surface should avoid sitting." Unfortunately, this recommendation has fueled the long standing view that people with pressure ulcers should stop using their wheelchairs and return to bed. The strength of evidence assigned for this recommendation was Level=C reflecting the paucity of research evidence to support this common practice. Not only do the benefits of bed rest on healing remain to be demonstrated, there is mounting evidence that bed rest can be harmful to a person's overall health and well being. Bed rest has been shown to be strongly associated with complications in most body systems including respiratory, cardiovascular, musculoskeletal, cerebrovascular, gastrointestinal, and genital-urinary. Psychosocial complications and cognitive impacts are also well documented. Without evidence to dispel the myth that "bed rest is best" it will be difficult to change practice and avoid many of the secondary complications. This study is a pilot study to 1) determine whether pressure ulcers heal faster in individuals with SCI who receive an individualized community-based, pressure management and mobility program compared to a similar group assigned to usual care (bed rest), 2) determine the strength of the association between the intervention (pressure/mobility or bedrest) and wound healing, motor performance/independence and quality of life while adjusting for motivation to regain independence, degree of caregiver burden, and compliance with the intervention, 3) determine whether individuals with SCI who participate in a pressure/mobility management program experience fewer secondary complications than those who do not participate, 4) determine the cost-effectiveness of providing a time-efficient, pressure management and mobility program compared to bed rest.

NCT ID: NCT00771238 Completed - Pressure Ulcers Clinical Trials

Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds

Start date: November 2008
Phase: N/A
Study type: Interventional

This pilot study will compare the incidence of pressure ulcers and the change in existing pressure ulcers for patients who are either placed on the new TC500 bed against those placed on the standard ICU bed in the Cardiovascular unit of University of Nebraska Medical Center. Additionally, the cost associated with rental beds will be calculated as well as skin care compliance. Sixty patients will be enrolled (30 per study arm).