Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries

ClinicalTrials.gov ID: NCT07828613

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ClinicalTrials.gov public records Last synced Nov 14, 2026, 6:48 PM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).

Study identification

NCT ID: NCT07828613
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Johns Hopkins University; Other
Enrollment: 356 participants

Conditions and interventions

Conditions

Interventions

Accelerated Flap Coverage Surgery Procedure
Standard of Care Flap Timing Procedure

Procedure

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 1, 2027 (Estimated)
Primary completion: Jul 2030 (Estimated)
Completion: Dec 2030 (Estimated)
Last update posted: Sep 18, 2026

2027 – 2030

United States locations

U.S. sites: 31
U.S. states: 21
U.S. cities: 27

Facility	City	State	ZIP	Site status
Banner - University Medical Center Phoenix	Phoenix	Arizona	85006	—
Keck Hospital of USC	Los Angeles	California	90033	—
Los Angeles Medical Center	Los Angeles	California	90033	—
Cedars-Sinai Medical Center	Los Angeles	California	90084	—
UC Davis Medical Center	Sacramento	California	95817	—
UC San Diego Health	San Diego	California	92121	—
Yale New Haven Hospital	New Haven	Connecticut	06510	—
University of Chicago Medicine	Chicago	Illinois	60637	—
IU Health University Hospital	Indianapolis	Indiana	46202	—
Louisiana State University Health Sciences Center	New Orleans	Louisiana	70112	—
University of Maryland - Shock Trauma Center	Baltimore	Maryland	21201	—
Johns Hopkins Hospital - Bayview Medical Center	Baltimore	Maryland	21224	—
Johns Hopkins Hospital	Baltimore	Maryland	21287	—
University of Maryland - Capital Region	Largo	Maryland	20774	—
Brigham and Women's Hospital	Boston	Massachusetts	02115	—
University of Mississippi Medical Center	Jackson	Mississippi	39216	—
University of Missouri Hospital	Columbia	Missouri	65212	—
University of Nebraska Medical Center	Omaha	Nebraska	68198	—
Jamaica Hospital Medical Center	The Bronx	New York	11418	—
University of Cincinnati Medical Center	Cincinnati	Ohio	45219	—
Ohio State University Wexner Medical Center	Columbus	Ohio	43221	—
Miami Valley Hospital	Dayton	Ohio	45409	—
Oregon Health & Science University	Portland	Oregon	97239	—
Brown University Health	Providence	Rhode Island	02903	—
Vanderbilt University Medical Center	Nashville	Tennessee	37232	—
The University of Texas Health Science Center at Houston	Houston	Texas	77030	—
University of Utah Hospital	Salt Lake City	Utah	84132	—
Inova Fairfax Hospital	Falls Church	Virginia	22042	—
UW Medical Center	Seattle	Washington	98195	—
University of Wisconsin Health University Hospital	Madison	Wisconsin	53792	—
Medical College of Wisconsin	Milwaukee	Wisconsin	53226	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07828613, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 18, 2026 · Synced Nov 14, 2026