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
About this trial
This is an interventional treatment trial for Ankle Injuries
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
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
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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