NCT00590551

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 31, 2008

Status Verified

December 1, 2008

Enrollment Period

1 year

First QC Date

December 31, 2007

Last Update Submit

December 30, 2008

Conditions

Wounds

Keywords

Skin BreakdownSkin DamageSkin IntegrityPressureSlings

Outcome Measures

Primary Outcomes (1)

  • There will be no difference in skin integrity with or without the use of slings.

    At 1 and 20 minutes pressure, pH and temperature will be measured.

Study Arms (1)

1-6

EXPERIMENTAL
Other: sling or no sling

Interventions

sling or no slingOTHER

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

Also known as: sling, no sling
1-6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • have positional hypotension
  • are on aspiration precautions
  • are paralyzed
  • have neuromuscular disease
  • have below the knee amputation(s)
  • weigh greater than 500 lbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmington Hospital

Wilmington, Delaware, 19899, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Suburethral Slings

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Denise Netta-Turner, BSN

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 10, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 31, 2008

Record last verified: 2008-12

Locations

US(1)