Bed Sore Research Studies

Bedsore Research Studies A Pilot Study of the Envision® Surface

Purpose:

This study is to evaluate the clinical safety and effectiveness of the Envision® surface.


Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model

Purpose:

Aim of the Study

Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using a pressure sore model.

Clinical Relevance

  • Accelerated healing of uncomplicated wounds
  • Enhanced healing of complicated (chronic, non-healing) wounds

Study Design

  • Prospective controlled phase I/II study
  • Cohort of 5 patients in pilot study, then reevaluation

Patients

Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the classification of Daniel and Seiler.

Methods

  1. First surgical intervention:
    • Radical debridement of pressure sore
    • Bone marrow harvest from the iliac crest
    • Isolation of hematopoietic stem cells, aiming to gain > 1 mio. CD 34+ cells per patient under GMP conditions
  2. Stem cell therapy (after 2 days):
    • Injection of stem cells in suspension (50’000 CD 34+ cells in 100 microliter saline per cm2 of wound surface) on one half of the total wound surface and cell-free saline on the other half as a control
  3. Second surgical intervention (after 3-4 weeks):
    • Complete excision of the wound
    • Closure of the defect by fasciocutaneous flap
  4. Evaluation of wound healing:
    • Clinical
    • 3D laser imaging
    • Histology
  5. Growth factor assay

Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study (WOUND)
  • Collaborator: Ontario Neurotrauma Foundation
  • Sponsor: University of Western Ontario, Canada
  • View study »

Purpose:

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 ofpressure ulcers produced by RNAO in 20027 recommended that “a client who has a pressure ulceron 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 bed rest) 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.


Oxandrolone to Heal Pressure Ulcers

Purpose:

This study is designed to determine whether the use of oxandralone, an anabolic steroid, can heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three VA SCI Units will screen and randomize patients into treatment with oxandralone or with placebo. Eleven other sites will screen patients to determine eligibility but will not treat patients with the agent. Following the Feasibility Study, all sites will participate in a blinded, randomized treatment study. A total of 400 patients will be enrolled over a four-year period. Any patient in a participating unit who has chronic SCI and a difficult-to-heal pelvic ulcer will be eligible for the study if other entry criteria are met. All enrolled patients will be followed for a period of 24 weeks to determine whether their target pressure ulcers heal. Those who are healed will be followed for an additional four weeks to determine whether the ulcer remains healed.


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

Purpose:

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).


Study of Thymosin Beta 4 in Patients with Pressure Ulcers

Purpose:

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers.


The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates – A Placebo Controlled Trial
  • Collaborator: Abbott
  • Sponsor: Changi General Hospital
  • View study »

Purpose:

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.


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