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Completed

NCT Number: NCT03477682

Postoperative Management of Groin Flaps for Vascular Coverage

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.

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Key information

Conditions

Functional Status After Sartorius Flap of the Groin Wound Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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 30 patients (15 per cohort).

Outcome measures include: surgical complication rates (including wound and lymphatic complications, readmissions, and reoperations), physical function, hospital length of stay, venous thromboembolism (VTE), and rates of discharge to a skilled nursing facility. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early ambulation

Other

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).

Primary outcomes

  1. Change in AM-PAC Score

    Time frame: 1 week

    AMPAC Score measures functional status

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 26, 2018
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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