Accelerated Flap Coverage for Severe Lower Limb Injuries
Accelerated Flap Coverage in Severe Lower Extremity Trauma
Recruiting
N/A
Interventional Study
Open Tibia Fracture
Open Dislocation of Ankle
Extremity Fracture Lower
Extremity Injuries Lower
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 356 (estimated)
- Sponsor
- Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for adults who have serious open fractures or dislocations below the knee that need surgery. Participants will be randomly assigned to receive surgery within 72 hours or later, and their progress will be monitored over six months.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 18 years old or older.
- I have a severe open fracture or dislocation below the knee that needs surgery.
- My surgery will be done by a participating surgeon.
- I can be enrolled in the trial within 48 hours of my injury.
You may not be able to join if
- The site can't provide the accelerated flap treatment.
- I am expected to have my limb amputated before the surgery.
- I have critical limb ischemia that needs immediate treatment.
- I have an infection at or near my injury.
- I have burns where my injury is.
- I am currently in jail.
- I am expected to live less than a year.
- I have a serious illness that means I won't live more than a year.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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.…
Trial Locations
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Eligibility Criteria
The inclusion criteria are:
1. Patients 18 years of age or older.
2. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.
3. Will have all planned flap surgeries performed by a participating surgeon or delegate.…
Contacts