Use of Perforator Flaps for Leg and Foot Reconstruction

Post Traumatic Skin Defect in Leg and Foot Clinical Trial

Official title:

Use of Perforator Flaps for Leg and Foot Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03269864
• Other study ID #: 17200122
• Status: Not yet recruiting
• Phase: N/A
• First received: August 28, 2017
• Last updated: August 30, 2017
• Start date: September 5, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Youssef Saleh Hassan, prof
• Phone: 01001166118
• Email: plasticclinic66[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Perforator vessels are those where the source artery is deep and the branch that carries blood to the fasciocutaneous tissues passes through the overlying deep fascia.

Soft tissue defects in the lower extremity, especially distal third of leg, present a challenge to reconstructive surgeons due to lack of reliable local flaps, conventional reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free tissue transfer. All these procedures have their limitations and associated morbidity at donor site

Description:

Taylor and Palmer defined an angiosome as a three-dimensional vascular territory supplied by a source artery and vein through branches for all tissue layers between the skin and the bone, and showed that between neighboring angiosomes there are choked and true anastomotic arteries.

Koshima and Soeda in 1989, described an inferior epigastric artery skin flap without the rectus abdominis muscle for reconstruction of floor of mouth, began the era of perforator flaps.

The big popularity gained by the local perforator flaps was due to their main advantages: 1) Sparing of the source artery and underlying muscle and fascia, 2) Combining the very good blood supply of a musculocutaneous flap with the reduced donor-site morbidity of a skin flap, 3) Replacing like with like, 4) Limiting the donor-site to the same area, 5) Possibility of completely or partially primarily closure, 6) Technically less demanding, because they are microsurgical procedures, but without microvascular sutures, 7) Shorter operating time.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Traumatic soft tissue defects on foot and leg.

2. Simple defects i.e., soft tissue loss, with or without, tendon injury.

3. Patients from 6 years to 60 years old

Exclusion Criteria:

1. Other causes of soft tissue defects e.g. (Diabetic, Vascular, post malignant resection).

2. Complex defects (soft tissue with bone injury).

3. Patients below 6 years or above 60 years old.

4. Patients with debilitating diseases e.g chronic renal failure, diabetes mellitus….etc.

Related Conditions & MeSH terms

• Post Traumatic Skin Defect in Leg and Foot

Intervention

Procedure:
• perforator flaps
40 patients with post traumatic skin defect at leg and foot will be managed by perforator flaps, 20 with pedicled perforator flaps and other 20 with free perforator flaps

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the perforator flap	The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering).	This will be assessed in the first week postoperative