Clinical trial NCT04967040: Reconstruction of Ankle and Foot Defects
Official title: A Comparative Study Between Distally Based Sural Artery Flap and Medial Plantar Artery Flap in Reconstruction of Ankle and Foot Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Foot Injury
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reconstruction of soft tissue defects around the foot and ankle region is a challenging problem for reconstructive surgeons due to the lack of locally available tissues for transposition, the relatively poor skin circulation, and the special structural characteristics of this area, bones and tendons can easily become exposed due to trauma. so foot injuries are often associated with a loss of soft tissues and exposed bones . The plantar skin is thick, with solid anchorage to the deep structures. Therefore, the reconstructive aim is to restore the stability of the foot skin to adapt to weightbearing and to resist shearing forces. In addition, good sensibility should be considered in the reconstruction. Additional considerations the ankle region has great tension during movement, and good stability is required for shoes wearing. The medial plantar flap has been effectively used in the reconstruction of soft tissue defects localized to the plantar foot, forefoot, posterior heel, and ankle in small to medium sized defects . This flap can be transferred to the defect as a proximally or distally pedicled island flap . The distally based sural artery flap frequently used for reconstruction of soft tissue defects of the lower leg, foot and ankle in medium and large sized defects .Fascio-cutaneous flaps are highly effective and easy to perform.

This study is a comparative study designed for assessment of the clinical applications of distally based sural flap versus medial plantar artery flap regarding the size of the defect , operative technique and their outcomes (success and complications) as a reconstructive option for foot and ankle defects.


Eligibility criteria: Inclusion Criteria:

Patients aging 5 to 70 years. Defect at the foot and ankle. Defect size (5- 15) cm2.

Exclusion Criteria:

Severe infection. Unhealthy skin of posterior or lateral aspect of leg . Defect more than 15 cm . Injury to vascular pedicle of the aimed flap .

Primary outcomes:
measure: Difference in functional outcome between group 1 and group 2
timeFrame: Difference in functional outcome between group 1 and group 2 is measured at 4 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Li X, Cui J, Maharjan S, Lu L, Gong X. Reconstruction of the Foot and Ankle Using Pedicled or Free Flaps: Perioperative Flap Survival Analysis. PLoS One. 2016 Dec 8;11(12):e0167827. doi: 10.1371/journal.pone.0167827. eCollection 2016.
citation: Hamdi MF, Kalti O, Khelifi A. Experience with the distally based sural flap: a review of 25 cases. J Foot Ankle Surg. 2012 Sep-Oct;51(5):627-31. doi: 10.1053/j.jfas.2012.05.029. Epub 2012 Jul 11.
citation: Uygur F, Duman H, Ulkur E, Noyan N, Celikoz B. Reconstruction of distal forefoot burn defect with retrograde medial plantar flap. Burns. 2008 Mar;34(2):262-7. doi: 10.1016/j.burns.2007.02.010. Epub 2007 Jul 20.