Use of Perforator Flaps for Leg and Foot Reconstruction

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

Study Overview

• Status: Unknown
• Conditions: Post Traumatic Skin Defect in Leg and Foot
• Intervention / Treatment: Procedure: perforator flaps

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: pedicled perforator flaps; Once the perforator is identified, the flap will be designed around the perforator or perforators according to the location and size of the defect. A tourniquet is inflated without prior exsanguination. This maneuver facilitates identification of perforators as they remain filled with the blood. An exploratory incision along the margin of flap is made keeping the position of marked perforator in mind. The incision is made through the skin, subcutaneous tissue, deep fascia (sub-fascial approach) and the perforator vessel is directly visualized. The incision is initially always made from one side of the flap only to properly identify the perforator. Careful and meticulous dissection is done in a blunt way isolating the perforator. After deflation of the tourniquet, hemostasis is performed.	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
ACTIVE_COMPARATOR: free perforator flaps; A two-team approach is used for microvascular free tissue transfer. The first team starts exploring the limb for the recipient vessel. The second team simultaneously begins elevating the perforator flap and its vascular pedicle. Microvascular anastomosis will be carried out under operating microscope for one artery and one or two accompanying veins.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 5, 2017
• Primary Completion (ANTICIPATED): January 1, 2019
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (ACTUAL): September 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 17200122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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