← Back to Search

Accelerated Flap Coverage for Leg Injuries (FLAP ATTACK Trial)

N/A

Recruiting

Led By Lily Mundy, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The

Patients 18 years of age or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if performing surgery to cover wounds within 72 hours after injury in patients with open fractures and dislocations below the knee reduces complications compared to the standard timing. Patients will be randomly

Who is the study for?

This trial is for adults over 18 with severe open fractures or dislocations below the knee that need a flap surgery. They must be able to enter the study within 48 hours of injury and have all surgeries done by participating surgeons. It's not suitable for those who can't follow the quick flap protocol due to local issues.

What is being tested?

The study compares two methods: accelerated flap coverage within 72 hours of injury versus standard timing at each hospital. The main focus is on infection-related complications, re-operations, amputations, mortality, and length of hospital stay after six months.

What are the potential side effects?

Potential side effects may include complications related to the surgical procedure such as infections, problems with wound healing (flap compromise), partial or complete loss of the tissue used in flap surgery (flap failure), and additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I need surgery for a severe injury below my knee.

Select...

I can start the trial within 2 days of my injury.

Select...

My injury surgeries will be done by a surgeon in the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical status

Secondary study objectives

Amputation

Mortality

Number of days in hospital

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Accelerated Flap CoverageExperimental Treatment1 Intervention

Accelerated flap surgery timing at a goal of within 72 hours from injury. Management of the fracture or dislocation, selection of flap, and post-injury flap management will be at the discretion of the operating surgeons and documented for both treatment groups.

Group II: Standard of Care Flap TimingActive Control1 Intervention

The flap surgery will be performed at the standard of care timing for the institution. Management of the fracture or dislocation, selection of flap, and post-injury flap management will be at the discretion of the operating surgeons and documented for both treatment groups.

0 / 5Eligibility criteria met