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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04906967
Other study ID # tissue coverage around ankle
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2021
Est. completion date July 2023

Study information

Verified date May 2021
Source Sohag University
Contact ahmed faisal
Phone 01095074338
Email ahmedfaysel@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date July 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
flaps
coverage of soft tissue defect around ankle

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

References & Publications (2)

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. — View 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. — View Citation

Outcome

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