Accelerated Flap Coverage for Leg Injuries

(FLAP ATTACK Trial)

Recruiting at 7 trial locations

Overseen By Lily Mundy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Critical limb ischemia, Chronic infection, Burns, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Up to 72 hours for accelerated group; variable for standard care

356 Participants Needed

Trial Summary

What is the purpose of 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. 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Accelerated Flap Coverage Surgery for leg injuries?

Research shows that performing soft tissue coverage within 72 hours of injury can significantly reduce the rates of flap failure and infection compared to later coverage. This supports the idea that early flap coverage, as in Accelerated Flap Coverage Surgery, may lead to better outcomes for leg injuries. ^{1 2 3 4 5}

Is Accelerated Flap Coverage for Leg Injuries generally safe for humans?

Research shows that early flap coverage for leg injuries can reduce serious complications compared to late reconstruction, with a serious complication rate of 8%. Additionally, using musculocutaneous flaps is associated with fewer complications than fasciocutaneous flaps, and local flaps require fewer revisions than free flaps. ^{4 5 6 7 8}

How is Accelerated Flap Coverage Surgery different from other treatments for leg injuries?

Accelerated Flap Coverage Surgery is unique because it emphasizes early soft-tissue reconstruction, ideally within a short time after injury, to improve healing and reduce complications. This approach contrasts with traditional methods that may delay flap coverage due to various factors, potentially leading to more complications and longer recovery times. ^{1 4 9 10 11}

Research Team

Lily Mundy, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

The

I need surgery for a severe injury below my knee.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either accelerated flap coverage within 72 hours or standard flap coverage timing as per institutional standard

Up to 72 hours for accelerated group; variable for standard care

In-patient hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 6 weeks, 3 months, 6 months, and 12 months post-randomization

Treatment Details

Interventions

• Accelerated Flap Coverage Surgery
• Standard of Care Flap Timing

Trial Overview 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.

Participant Groups

Group I: Accelerated Flap Coverage Experimental Treatment 1 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 Timing Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Orthopaedic Trauma Association

Collaborator

Trials

34

Recruited

5,100+

Foundation of Orthopedic Trauma

Collaborator

Trials

4

Recruited

530+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Findings from Research

In a study of 51 patients who underwent microsurgical reconstruction of the lower extremity, performing the surgery more than 15 days after injury did not significantly affect outcomes such as flap failure, osteomyelitis, bony union, or ambulation.

This suggests that delaying microsurgical reconstruction beyond 15 days can be a safe option without compromising the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microsurgical Lower Extremity Reconstruction in the Subacute Period: A Safe Alternative. Starnes-Roubaud, MJ., Peric, M., Chowdry, F., et al.[2020]

Covering traumatic extremity wounds with soft tissue within 72 hours of injury significantly reduces total flap failure rates (1.4% vs. 8.8%) and partial flap failure rates (0.4% vs. 1.8%) compared to coverage after 72 hours, based on a review of 21 studies involving 1267 patients.

Infection rates were also lower for early coverage (<72 hours: 7.7% vs. >72 hours: 11.6%), supporting the idea that timely intervention can improve outcomes in soft tissue reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Godina revisited: a systematic review of traumatic lower extremity wound reconstruction timing. Qiu, E., Kurlander, DE., Ghaznavi, AM.[2019]

In a study of 25 patients, the distally based sural flap demonstrated an 80% complete survival rate for covering soft tissue defects in the lower leg and foot, indicating its efficacy as a reconstructive option.

The procedure is advantageous due to its simplicity, short operating time, and minimal donor site morbidity, making it a reliable choice for plastic surgeons in managing lower extremity defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distally based sural fasciocutaneous flap for soft tissue reconstruction of the distal leg, ankle and foot defects. Ajmal, S., Khan, MA., Khan, RA., et al.[2010]

In a study of 52 patients with lower leg soft-tissue defects, there was no significant difference in postoperative complications between local and free flap treatments, although free flap patients required more revisions.

Musculocutaneous flaps were associated with fewer postoperative complications compared to fasciocutaneous flaps, and the timing of the operation (within or after 72 hours post-trauma) did not significantly affect outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of soft-tissue defects of the lower leg after a traumatic open tibial fracture. Franken, JM., Hupkens, P., Spauwen, PH.[2021]

A study of 35 patients who underwent free flap surgery for lower extremity trauma found that both subacute (10-29 days post-injury) and delayed (more than 30 days post-injury) surgical timings resulted in favorable outcomes without significant differences in flap failure or complication rates.

The results suggest that with proper wound preparation and careful preoperative planning, both timing strategies can be effective for reconstructive surgery in traumatic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of subacute and delayed free flap reconstruction in the treatment of open lower extremity fractures. Arslan, H., Demiröz, A.[2022]

In a study involving 27 patients with bone injuries and soft-tissue loss, a treatment protocol aimed at achieving definitive wound coverage within 10 days resulted in 19 successful microvascular tissue transfers and 8 pedicle flaps.

The protocol led to a low serious complication rate of 8% and significantly reduced patient morbidity compared to previous late reconstruction methods, highlighting its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex osteocutaneous injuries--timing of reconstruction. A report of 3 cases. Barnard, CJ., Wei, FC., Badenhorst, OA.[2004]

The lateral supramalleolar flap (LSMF) showed no cases of flap necrosis and required fewer surgical stages compared to the reverse sural flap (RSF), which had five cases of necrosis and a higher mean number of stages needed for recovery.

Patients in the LSMF group reported significantly better foot function and higher satisfaction outcomes, with 14 patients rating their results as 'excellent', compared to the RSF group, which had more varied satisfaction ratings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empirical Evidence on the Reliability of Lateral Supramalleolar Flap over Reverse Sural Flap for Local Soft Tissue Coverage of Dorsum of the Foot and Ankle Defects. Jaiswal, KS., Gupta, S., Goil, P., et al.[2023]

In a study of 12 patients with soft-tissue defects on the lower leg, ankle, or heel, a distally based sural neurocutaneous flap provided stable coverage for all defects, demonstrating its efficacy even in high-risk patients.

Postoperative results showed that 10 out of 12 patients achieved primary wound healing, and all patients were satisfied with the outcome, although some reported minor complications like loss of sensation and aesthetic concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The distally based sural neurocutaneous island flap for coverage of soft-tissue defects on the distal lower leg, ankle and heel]. Rudig, LL., Gercek, E., Hessmann, MH., et al.[2022]

The paper discusses various techniques for advancing flaps to effectively cover traumatic ulcers on the legs, highlighting the importance of these methods in surgical treatment.

It emphasizes the benefits of using direct, uncrossed flap techniques, which may offer improved outcomes for patients with leg ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower limb to limb flaps for repair of traumatic ulcers. Dulanto, F., Armijo, M., Camacho, F.[2019]

In a study of 7 patients with extensive foot and ankle skin defects due to major trauma, free flap surgery using various muscle and tissue types effectively covered the defects, with most cases treated within 48 hours of injury.

The study highlights that timely intervention is crucial for successful outcomes, as only one case experienced complications due to delayed treatment, while all other cases healed well without further issues like osteitis or arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of extensive traumatic loss of substance of the foot and ankle by free flaps. Apropos of 7 clinical cases]. Tropet, Y., Najean, D., Brientini, JM., et al.[2006]

A case study demonstrated the successful use of an inner thigh flap to cover the ankle and foot of a patient with poor vascularization, following amputation of the left leg due to severe burns.

This technique shows promise as a viable alternative to traditional flaps (like sural and supramalleolar flaps) for patients at risk of vascular complications, highlighting its potential in complex reconstructive surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The inner flap of the thigh: an alternative about the cover of the ankle and the foot]. Sica, A., Kamenan, K., Ouedé, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Microsurgical Lower Extremity Reconstruction in the Subacute Period: A Safe Alternative. [2020]

2. Sweden pubmed.ncbi.nlm.nih.gov

Godina revisited: a systematic review of traumatic lower extremity wound reconstruction timing. [2019]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Distally based sural fasciocutaneous flap for soft tissue reconstruction of the distal leg, ankle and foot defects. [2010]

4. Germany pubmed.ncbi.nlm.nih.gov

The treatment of soft-tissue defects of the lower leg after a traumatic open tibial fracture. [2021]

5. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of subacute and delayed free flap reconstruction in the treatment of open lower extremity fractures. [2022]

6. South Africa pubmed.ncbi.nlm.nih.gov

Complex osteocutaneous injuries--timing of reconstruction. A report of 3 cases. [2004]

7. Germany pubmed.ncbi.nlm.nih.gov

Empirical Evidence on the Reliability of Lateral Supramalleolar Flap over Reverse Sural Flap for Local Soft Tissue Coverage of Dorsum of the Foot and Ankle Defects. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[The distally based sural neurocutaneous island flap for coverage of soft-tissue defects on the distal lower leg, ankle and heel]. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Lower limb to limb flaps for repair of traumatic ulcers. [2019]

10. France pubmed.ncbi.nlm.nih.gov

[Treatment of extensive traumatic loss of substance of the foot and ankle by free flaps. Apropos of 7 clinical cases]. [2006]

11. France pubmed.ncbi.nlm.nih.gov

[The inner flap of the thigh: an alternative about the cover of the ankle and the foot]. [2022]