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

Primary Purpose

Ankle Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
flaps
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • patients aging 5 to 70 years.

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    modified sural flap

    anterolateral thigh flap

    Arm Description

    modified sural flap used to cover soft tissue defect around ankle

    anterolateral thigh flap used to cover soft tissue defect around ankle

    Outcomes

    Primary Outcome Measures

    Viability of the flap
    Viability of flap detected by numbers of flap survived in each group
    Size of defect covered(size of the flap)
    Detected by measuring the length and width in cms
    Resistance to infection
    Detected by numbers of flabs in each group that resist infection

    Secondary Outcome Measures

    Full Information

    First Posted
    May 20, 2021
    Last Updated
    May 25, 2021
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04906967
    Brief Title
    Sural Flap and Anterolateral Thigh Flap in Tissue Reconstruction Around the Ankle
    Official Title
    A Comparative Study of Modified Sural Flap and Anterolateral Thigh Flap in Soft Tissue Reconstruction of Lower Extremity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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
    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: The defect is allowed to heal by secondary intention. The wound is closed primarily. A split or full thickness skin graft and or neodermis is applied. A local random flap or propeller flap is transposed or advanced. A pedicled or island flap is transferred. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    modified sural flap
    Arm Type
    Active Comparator
    Arm Description
    modified sural flap used to cover soft tissue defect around ankle
    Arm Title
    anterolateral thigh flap
    Arm Type
    Active Comparator
    Arm Description
    anterolateral thigh flap used to cover soft tissue defect around ankle
    Intervention Type
    Procedure
    Intervention Name(s)
    flaps
    Intervention Description
    coverage of soft tissue defect around ankle
    Primary Outcome Measure Information:
    Title
    Viability of the flap
    Description
    Viability of flap detected by numbers of flap survived in each group
    Time Frame
    baseline
    Title
    Size of defect covered(size of the flap)
    Description
    Detected by measuring the length and width in cms
    Time Frame
    Baseline
    Title
    Resistance to infection
    Description
    Detected by numbers of flabs in each group that resist infection
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • patients aging 5 to 70 years. Defect at the lower leg ,ankle or foot Palpable distal pulse 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed faisal
    Phone
    01095074338
    Email
    ahmedfaysel@med.sohag.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31785835
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21351140
    Citation
    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.
    Results Reference
    background

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

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