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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03185663
Other study ID # I15010 / ALGOFRACT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2017
Est. completion date May 25, 2021

Study information

Verified date November 2020
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Mobilization, source of pain, is also problematic. 759/5000


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 25, 2021
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - Patient aged 70 and over, - Extracapsular fracture isolated from the proximal end of the femur, - Informed consent of the patient for participation in the study, - Patient affiliated to a social security scheme. Exclusion Criteria: - Restlessness or fragile skin condition that may prevent the establishment or maintenance of traction stuck preoperatively - Insane or confounding Pathology, - Predictable time before operation> to 72 hours (eg anticoagulated patient orally before the fracture [antiplatelet agents are allowed], other associated diseases: urinary tract infection, pneumonia ...) - Patient under guardianship, curatorship, or under judicial protection.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
traction-stuck
continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight
a pillow between the legs
setting up a pillow between the legs before the care

Locations

Country Name City State
France Limoges Hospital Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score from pain immediately after washing, the day of surgery preoperatively 5 minutes
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