Clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns: study protocol for a randomized controlled trial.

Zjir M. Rashaan,Fenike R. H. Tempelman,Cees H. van der Vlies,M. Elske van den Akker- van Marle,Adrianus F. P. Vloemans,Jan Dokter,Margriet E. van Baar,Roelf S. Breederveld,Pieta Krijnen

doi:10.1186/s13063-016-1240-5

Abstract

BackgroundPartial thickness burns are painful, difficult to manage and can have a negative effect on quality of life through scarring, permanent disfigurement and loss of function. The aim of burn treatment in partial thickness burns is to save lives, stimulate wound healing by creating an optimumly moist wound environment, to have debriding and analgesic effects, protect the wound from infection and be convenient for the patient and caregivers. However, there is no consensus on the optimal treatment of partial thickness wounds. Flaminal® and Flamazine® are two standard treatment options that provide the above mentioned properties in burn treatment. Nevertheless, no randomized controlled study has yet compared these two common treatment modalities in partial thickness burns. Thus, the aim of this study is to evaluate the clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns.Methods/DesignIn this two-arm open multi-center randomized controlled trial, 90 patients will be randomized between Flaminal® and Flamazine® and followed for 12 months. The study population will consist of competent or temporarily non-competent (because of sedation and/or intubation) patients, 18 years of age or older, with acute partial thickness burns and a total body surface area (TBSA) of less than 30 %. The main study outcome is time to complete re-epithelialization (greater than 95 %). Secondary outcome measures include need for grafting, wound colonization/infection, number of dressing changes, pain and anxiety, scar formation, health-related quality of life (HRQoL), and costs.DiscussionThis study will contribute to the optimal treatment of patients with partial thickness burn wounds and will provide evidence on the (cost-)effectiveness and quality of life of Flaminal® versus Flamazine® in the treatment of partial thickness burns.Trial registrationNetherlands Trial Register NTR4486, registered on 2 April 2014.

Highlights

Partial thickness burns are painful, difficult to manage and can have a negative effect on quality of life through scarring, permanent disfigurement and loss of function
This study will contribute to the optimal treatment of patients with partial thickness burn wounds and will provide evidence on theeffectiveness and quality of life of Flaminal® versus Flamazine® in the treatment of partial thickness burns
The aim of this study is to evaluate the clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® (SSD) in the treatment of partial thickness burns

Summary

Introduction

Partial thickness burns are painful, difficult to manage and can have a negative effect on quality of life through scarring, permanent disfigurement and loss of function. The aim of burn treatment in partial thickness burns is to save lives, stimulate wound healing by creating an optimumly moist wound environment, to have debriding and analgesic effects, protect the wound from infection and be convenient for the patient and caregivers. The aim of this study is to evaluate the clinical effectiveness, quality of life and costeffectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns. The aim of burn treatment in partial thickness burns is to promote rapid wound healing, decrease pain and suffering, protect the wound from infection, minimize scar formation and functional impairment, and to enable patients to return to normal daily activities as soon as possible [2, 3]. Silver-containing dressings and topicals, in particular silver sulfadiazine (SSD), have been the most commonly used burn wound dressing in the treatment of partial thickness burns for over 30 years [4,5,6,7,8]

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