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Status unknownNCT04906967Updated May 28, 2021

Sural Flap and Anterolateral Thigh Flap in Tissue Reconstruction Around the Ankle

An interventional study of flaps in Ankle Injuries, sponsored by Sohag University. Status unknown. Open to participants aged 5 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-28.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
5 Years to 70 Years
Sex
All
01

Study summary

The aim of the study is to evaluate the outcomes of coverage of soft tissue defects of leg and foot by modified sural flap versus anterolateral thigh flap

Read the detailed description

The leg and foot contain a thin subcutaneous layer and few muscles, thus the tibia and tendons can easily become exposed due to trauma. Therefore leg and foot injuries are often associated with a loss of soft tissues and exposed fractures.

one of the following reconstructive options are chosen:

  1. The defect is allowed to heal by secondary intention.
  2. The wound is closed primarily.
  3. A split or full thickness skin graft and or neodermis is applied.
  4. A local random flap or propeller flap is transposed or advanced.
  5. A pedicled or island flap is transferred.
  6. A microvascular free flap is transferred. The method of soft tissue reconstruction chosen hinges on the patient's medical condition, the surgeon's experience, the size of the wound, the vascular status of the foot and the exposed structures the skin in this region has low flexibility and the subcutaneous circulation does not allow the use of long randomized flaps, the task of finding flaps to cover bones or tendons in wounds with cutaneous loss in the legs and feet is difficult.

The sural flap acts as an axial flap and has 3 sources of nutrition,the vascular plexus of the deep fascia, the medial superficial sural artery which follows the medial sural nerve and the arteries that follow the minor saphenous vein. Venous return is ensured by the minor saphenous vein which may be used as a distal pedicle to provide reverse flow.

sural flap has the advantages of easy and quick harvesting without sacrificing major arteries and can be done in one stage operation.

In the other hand,Since introduction of the anterolateral thigh flap in 1984 by Song et al it has gained widespread popularity, especially in Asian countries, where it has replaced the radial forearm flap as being the workhorse in head and neck surgery.

Anterolateral thigh flaps have been introduced also in lower extremity reconstruction.

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Conditions studied

  • Ankle Injuries

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03

In context

Ankle Injuries

352 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.

This study's planned enrollment of 32 is below the median of 56 across 273 interventional studies indexed under Ankle Injuries.

Browse Ankle Injuries studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • patients aging 5 to 70 years.

      • Defect at the lower leg ,ankle or foot
      • Palpable distal pulse

Exclusion criteria

Exclusion Criteria:

    • Peripheral vascular disease

      • Underling bone osteomyelitis
      • Unhealthy skin of posterior or lateral aspect of leg.
      • Vascular injury.
      • Patients with chronic diseases
      • Patients associated with vital organ injuries
      • Patients unfit to surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
32 participants (estimated)

Study arms

  • Active comparator
    modified sural flap

    modified sural flap used to cover soft tissue defect around ankle

    Procedure: flaps

  • Active comparator
    anterolateral thigh flap

    anterolateral thigh flap used to cover soft tissue defect around ankle

    Procedure: flaps

Interventions

  • Procedureflaps

    coverage of soft tissue defect around ankle

06

What researchers measure

Primary outcomes

  1. Viability of the flap

    Viability of flap detected by numbers of flap survived in each group

    Time frame: baseline

  2. Size of defect covered(size of the flap)

    Detected by measuring the length and width in cms

    Time frame: Baseline

  3. Resistance to infection

    Detected by numbers of flabs in each group that resist infection

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Noaman HH, Soroor YO. Foot salvage using microsurgical free muscle flaps in severely crushed foot with soft tissue defects. Injury. 2019 Dec;50 Suppl 5:S17-S20. doi: 10.1016/j.injury.2019.10.040. Epub 2019 Oct 23. PubMed 31785835 ↗
  • Battiston B, Antonini A, Tos P, Daghino W, Massazza G, Riccio M. Microvascular reconstructions of traumatic-combined tissue loss at foot and ankle level. Microsurgery. 2011 Mar;31(3):212-7. doi: 10.1002/micr.20863. Epub 2011 Feb 23. PubMed 21351140 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04906967
Lead sponsor
Sohag University
Responsible party
Ahmed Faisal Esmael Mahmoud (Assistant lecturer in orthopedic department,faculty of medicine,sohag university,Sohag Governorate, Sohag University) — Principal investigator
First posted
May 28, 2021
Start date
Jun 2021 (estimated)
Primary completion
Jun 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
May 28, 2021

Study contacts

ahmed faisal
Contact
ahmedfaysel@med.sohag.edu.eg
01095074338

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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