Vascular Impulse Technology versus elevation in the treatment of posttraumatic swelling of extremity fractures: study protocol for a randomized controlled trial

Marc Schnetzke,Svenja Schüler,Benedict Swartman,Holger Keil,Jochen Franke,Paul A Grützner,Isabel Bonnen

doi:10.1186/s13063-017-1824-8

Abstract

BackgroundFractures of the extremities are often complicated by a variable degree of swelling secondary to hemorrhage and soft tissue injury. Patients typically require up to 7 days of inpatient bed rest and elevation to reduce swelling to an acceptable level for operative treatment with internal fixation. Alternatively, an intermittent pneumatic compression device, such as the Vascular Impulse Technology (VIT) system, can be used at the injured extremity to reduce the posttraumatic swelling. The VIT system consists of a pneumatic compressor that intermittently rapidly inflates a bladder positioned under the arch of the hand or the foot, which results in compression of the venous hand or foot plexus. That intermittent compression induces an increased venous velocity and aims to reduce the soft tissue swelling of the affected extremity.Methods/designThe VIT study is a prospective, monocenter, randomized controlled trial to compare the VIT system with elevation in the treatment of posttraumatic swelling in the case of a fracture of the upper and lower extremity. This study will include 280 patients with fractures of the upper and the lower extremity with nine different injury types. For each of the nine injury types a separate randomization to the two intervention groups (VIT group or control group) will be performed. The primary outcome parameter is the time taken for the swelling to resolve sufficiently to permit surgery. A separate analysis for each of the nine injury types will be performed.DiscussionIn the proposed study, the effectiveness of the VIT system in the treatment of posttraumatic swelling of upper and lower extremity fractures will be evaluated.Trial registrationGerman Clinical Trial Register, No. DRKS00010510. Registered on 17 July 2016.

Highlights

Fractures of the extremities are often complicated by a variable degree of swelling secondary to hemorrhage and soft tissue injury
The definition of operability is decided by these blinded examiners based on two basic rules: (1) that there is crumpling of the skin at the surgical side and (2) that suturing of the skin without tension will be possible after definitive operative treatment
If there are two or more treatment options for one clinical condition a randomized controlled trial with a clinically relevant endpoint should determine, which is more beneficial to the patient [25]

Summary

Introduction

Fractures of the extremities are often complicated by a variable degree of swelling secondary to hemorrhage and soft tissue injury. An intermittent pneumatic compression device, such as the Vascular Impulse Technology (VIT) system, can be used at the injured extremity to reduce the posttraumatic swelling. That intermittent compression induces an increased venous velocity and aims to reduce the soft tissue swelling of the affected extremity. Some IPC devices have different pump characteristics but generally tend to rapidly inflate to a pressure of approximately 100 mmHg in less than half a second (Fig. 1). These systems have been shown to stimulate venous return in the immobile lower limb as effectively as walking [20]

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