Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
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|ClinicalTrials.gov Identifier: NCT03592316|
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lower Extremity Amputation||Other: Lower Extremity Amputation Pathway||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients|
|Actual Study Start Date :||November 14, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: Lower Extremity Amputation Pathway
Patients will follow the Lower Extremity Amputation Pathway, which will include pre-operative consultations and earlier progression with physical therapy post-operatively.
Other: Lower Extremity Amputation Pathway
Pre-operatively: Subjects will meet with social work/case management, physical therapy, anesthesiology, and the prosthetist for the following: discuss expectations and rehabilitation; pain control options and consideration for epidural or nerve block; prosthetic treatment and care timeline.
Post-operatively: Physical therapy will begin on post-op day 1 with increasing complexity through post-op day 3. On post-op day 3 the wound will be examined by the surgeon and subjects will be cleared for discharge.
Quality of life surveys will be given at several time points during post-operative care.
- Hospital length of stay [ Time Frame: Through hospital discharge, approximately 3 days after surgery ]The total hospital length of stay for the lower extremity amputation admission
- Mortality [ Time Frame: Up to 6 months after surgery ]Mortality during the follow-up period
- Major adverse limb event [ Time Frame: Up to 6 months after surgery ]Hematoma, infection, ischemia, and/or need for revision of amputation
- In-hospital morbidity [ Time Frame: Through hospital discharge, approximately 3 days after surgery ]Catheter Associated Urinary Tract Infection, Pneumonia, Deep Vein Thrmbosis, and/or Pulmonary Embolism
- Return to functional independence [ Time Frame: Up to 6 months after surgery ]Time to return to functional independence at home
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592316
|Contact: Rachel Dirks, PhDfirstname.lastname@example.org|
|United States, California|
|Community Regional Medical Center||Recruiting|
|Fresno, California, United States, 93721|
|Contact: Rachel Dirks, PhD|
|Principal Investigator:||Leigh Ann O'Banion, MD||University of California, San Francisco|