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

A Comparative Study of Modified Sural Flap and Anterolateral Thigh Flap in Soft Tissue Reconstruction of Lower Extremity

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Injuries
• Intervention / Treatment: Procedure: flaps

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed faisal; Phone Number: 01095074338; Email: ahmedfaysel@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: modified sural flap; modified sural flap used to cover soft tissue defect around ankle	Procedure: flaps; coverage of soft tissue defect around ankle
ACTIVE_COMPARATOR: anterolateral thigh flap; anterolateral thigh flap used to cover soft tissue defect around ankle	Procedure: flaps; coverage of soft tissue defect around ankle

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (ACTUAL): May 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: tissue coverage around ankle

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No