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Slings and Their Effect on Skin Pressure

This study has been terminated.
(unable to recruit patients for study)
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00590551
First received: December 31, 2007
Last updated: December 30, 2008
Last verified: December 2008
History of Changes
  Purpose

There are many reasons that cause skin to breakdown. This study will only compare

  • pressure
  • pH
  • temperature

with the use of slings and without the use of slings (fabricated device used to safely handle patient transfers and repositioning).

There will be no difference in skin pressure, pH, or temperature with or without the use of slings.


Condition Intervention
Wounds
 Other: sling or no sling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Slings and Repositioning Devices: Their Effects on Skin Pressure

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • There will be no difference in skin integrity with or without the use of slings. [ Time Frame: At 1 and 20 minutes pressure, pH and temperature will be measured. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1-6 Other: sling or no sling
Groups will be assigned as follows: 1-supine and with sling, 2-30o HOB elevation without leg elevation and with sling, 3-30o HOB elevation with 10o leg elevation and with sling, 4-supine and without sling, 5-30o HOB elevation without leg elevation and without sling, and 6-30o HOB elevation with 10o leg elevation and without sling
Other Names:
  • sling
  • no sling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • need assistance with mobility, using any patient handling equipment
  • are ≥ 18 years of age
  • are English speaking or guardian is English speaking
  • are medically stable

Exclusion Criteria:

  • have positional hypotension
  • are on aspiration precautions
  • are paralyzed
  • have neuromuscular disease
  • have below the knee amputation(s)
  • weigh greater than 500 lbs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590551

Locations
United States, Delaware
Wilmington Hospital
Wilmington, Delaware, United States, 19899
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Denise Netta-Turner, BSN Christiana Care Health System
  More Information

No publications provided

Responsible Party: Denise Netta-Turner, BSN, CWOCN, CEAS, Christiana Care Health System
ClinicalTrials.gov Identifier: NCT00590551     History of Changes
Other Study ID Numbers: 27208
Study First Received: December 31, 2007
Last Updated: December 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Skin Breakdown
Skin Damage
Skin Integrity
Pressure
Slings

ClinicalTrials.gov processed this record on May 21, 2013