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Postoperative Management of Groin Flaps for Vascular Coverage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03477682
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is a randomized controlled trial designed to analyze the impact of bedrest duration on return to functional independence at discharge following sartorius flap for coverage of vascular reconstruction in the groin.

Condition or disease Intervention/treatment Phase
Functional Status After Sartorius Flap of the Groin Wound Complication Other: Early ambulation Not Applicable

Detailed Description:

This is a pilot prospective study with the purpose of evaluating the impact of bedrest duration on outcomes of groin muscle flaps used for groin coverage in patients undergoing open, infrainguinal vascular surgery. The investigators plan to target all patients undergoing groin muscle flaps for vascular groin coverage at UCSF.

All patients undergoing groin flaps will be block randomized into two cohorts: Cohort 1 - one day of bedrest (mobilize on post-op day 2) versus Cohort 2 - 5 days of bedrest (mobilize on post-op day 6).

The investigators perform approximately 50 infrainguinal muscle flaps per year. They aim to enroll 140 patients (70 per cohort).

The primary outcome is return to functional independence at discharge. Secondary outcomes include wound dehiscence, infection, reoperation, interventional radiology intervention, seroma, and sequela associated with prolonged bedrest including respiratory infections, duration of hospitalization, need for SNF upon discharge, and physiologic deconditioning. The investigators will also examine the impact of bedrest on patient reported outcomes one month following surgery. Patient outcomes will be followed for 3 months post-operatively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: The plastic surgeon who performs the sartorius flap does not know which group the patient will be randomized to (early ambulation versus standard 5 days bedrest) until after the surgery is completed.
Primary Purpose: Treatment
Official Title: Postoperative Management of Groin Flaps for Vascular Coverage
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Early Ambulation Group
The patient will remain on bed rest for one day following surgery and will be encouraged to be out of bed and ambulating on the second day following surgery.
Other: Early ambulation
Patients who are in the experimental arm will have a shorter duration of bedrest restriction following sartorius surgery (1 day) versus the standard group (5 days bedrest).

No Intervention: Standard Group
The patient will remain on bed rest for five days following surgery and will be encouraged to be out of bed and ambulating on the sixth day following surgery.



Primary Outcome Measures :
  1. Change in Barthel Index [ Time Frame: 2 weeks ]
    Barthel Index measures functional status. It is scored from 0 - 20. Lower scores indicate increased disability. Compare functional status before surgery and at time of discharge using Barthel Index.


Secondary Outcome Measures :
  1. Wound infection requiring medication [ Time Frame: 3 months ]
    Described infection requiring antibiotics only, no surgery

  2. Superficial wound dehiscence [ Time Frame: 3 months ]
    Dehiscence of superficial layers (skin and subcutaneous tissue) requiring local wound care. Information will be gathered from medical record as charted by provider describing superficial wound dehiscence or via picture in the chart. This means separation at the skin level and may include, epidermis, dermis or subcutaneous fat or all three.

  3. Deep wound dehiscence [ Time Frame: 3 months ]
    Dehiscence of wound down to fascia, muscle, exposed vessels, requiring surgery. Information will be gathered from medical record as charted by provider or via picture. It will be described as wound dehiscence beyond the subcutaneous tissue down to fascia, muscle or exposed vessel and that required a re-operation by the plastic surgery team.

  4. Wound infection requiring surgery [ Time Frame: 3 months ]
    Wound infection or abscess requiring surgery (debridement, incision and drainage, exploration)

  5. Length of hospital stay [ Time Frame: 2 weeks ]
    Length of hospitalization following surgery, measured in days

  6. Rehabilitation [ Time Frame: 3 months ]
    Type of rehabilitation after surgery (home health, skilled nursing facility, home physical therapy, none)

  7. SF36 Score [ Time Frame: 3 months ]
    This survey measures quality of life and will be used to examine the impact of bedrest on patient reported quality of life outcomes postoperatively. Total scores range from 0-100 with higher scores indicating a more favorable state.

  8. C-reactive protein [ Time Frame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six. ]
    A measure of nutritional status, measured on first day of mobilization

  9. Albumin [ Time Frame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six. ]
    A measure of nutritional status, measured on first day of mobilization

  10. Pre-albumin [ Time Frame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six. ]
    A measure of nutritional status, measured on first day of mobilization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients undergoing muscle flaps following infrainguinal, open vascular surgery. Patients must be ambulatory at baseline. Patients must be able to provide informed consent.

Exclusion Criteria:

  • Patients who are unable to provide informed consent. Patients are non-ambulatory at baseline. Patients' clinical status is not amenable towards early ambulation. Enrollment is at the discretion of the vascular and plastic surgeons.
  • Bilateral sartorius flaps

Information from the National Library of Medicine

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): NCT03477682


Contacts
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Contact: Scott L Hansen, MD 4153534285 scott.hansen@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Scott L Hansen, MD    415-353-4285    scott.hansen@ucsf.edu   
Contact: Audrey Nguyen, MD    4153534285    audrey.nguyen@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Scott L Hansen, MD University of California, San Francisco
Publications of Results:
Other Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03477682    
Other Study ID Numbers: 15-17005
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No