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

NCT ID: NCT04906967

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Ankle Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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modified sural flap

modified sural flap used to cover soft tissue defect around ankle

Group Type ACTIVE_COMPARATOR

flaps

Intervention Type PROCEDURE

coverage of soft tissue defect around ankle

anterolateral thigh flap

anterolateral thigh flap used to cover soft tissue defect around ankle

Group Type ACTIVE_COMPARATOR

flaps

Intervention Type PROCEDURE

coverage of soft tissue defect around ankle

Interventions

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flaps

coverage of soft tissue defect around ankle

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Faisal Esmael Mahmoud

Assistant lecturer in orthopedic department,faculty of medicine,sohag university,Sohag Governorate

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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ahmed faisal

Role: CONTACT

Phone: 01095074338

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 31785835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21351140 (View on PubMed)

Other Identifiers

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tissue coverage around ankle

Identifier Type: -

Identifier Source: org_study_id