title: 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.
abstract: BACKGROUND
  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. 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
  In 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Netherlands Trial Register NTR4486 , registered on 2 April 2014.
authors.affiliation: Department of Surgery, Leiden University Medical Center, Postbus 9600, 2333 ZA, Leiden, The Netherlands. zrashaan@rkz.nl.|Burn Centre, Red Cross Hospital Beverwijk, Postbus 1074, 1942 LE, Beverwijk, The Netherlands. zrashaan@rkz.nl.
authors.forename: Zjir M
authors.initials: ZM
authors.lastname: Rashaan
authors.affiliation: Department of Surgery, Leiden University Medical Center, Postbus 9600, 2333 ZA, Leiden, The Netherlands. p.krijnen@lumc.nl.
authors.forename: Pieta
authors.initials: P
authors.lastname: Krijnen
authors.affiliation: Department of Medical Decision Making, Leiden University Medical Centre, PO 9600, 2333 ZA, Leiden, The Netherlands. m.e.van_den_akker-van_marle@lumc.nl.
authors.forename: M Elske
authors.initials: ME
authors.lastname: van den Akker-van Marle
authors.affiliation: Association of Dutch Burn Centres, Postbus 1015, 1940 EA, Beverwijk, The Netherlands. BaarM@maasstadziekenhuis.nl.|Burn Centre, Maasstad Hospital, PO Box 9100, 3079 DZ, Rotterdam, The Netherlands. BaarM@maasstadziekenhuis.nl.
authors.forename: Margriet E
authors.initials: ME
authors.lastname: van Baar
authors.affiliation: Burn Centre, Red Cross Hospital Beverwijk, Postbus 1074, 1942 LE, Beverwijk, The Netherlands. jvloemans@rkz.nl.
authors.forename: Adrianus F P
authors.initials: AF
authors.lastname: Vloemans
authors.affiliation: Burn Centre, Maasstad Hospital, PO Box 9100, 3079 DZ, Rotterdam, The Netherlands. dokterj@maasstadziekenhuis.nl.
authors.forename: Jan
authors.initials: J
authors.lastname: Dokter
authors.affiliation: Burn Centre, Red Cross Hospital Beverwijk, Postbus 1074, 1942 LE, Beverwijk, The Netherlands. ftempelman@rkz.nl.
authors.forename: Fenike R H
authors.initials: FR
authors.lastname: Tempelman
authors.affiliation: Burn Centre, Maasstad Hospital, PO Box 9100, 3079 DZ, Rotterdam, The Netherlands. vliesc@maasstadziekenhuis.nl.
authors.forename: Cees H
authors.initials: CH
authors.lastname: van der Vlies
authors.affiliation: Department of Surgery, Leiden University Medical Center, Postbus 9600, 2333 ZA, Leiden, The Netherlands. rbreederveld@rkz.nl.|Burn Centre, Red Cross Hospital Beverwijk, Postbus 1074, 1942 LE, Beverwijk, The Netherlands. rbreederveld@rkz.nl.|Association of Dutch Burn Centres, Postbus 1015, 1940 EA, Beverwijk, The Netherlands. rbreederveld@rkz.nl.
authors.forename: Roelf S
authors.initials: RS
authors.lastname: Breederveld
mesh_terms: D000464:Alginates / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D000891:Anti-Infective Agents, Local / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D002056:Burns / Q000150:complications / Q000188:drug therapy* / Q000191:economics* / Q000523:psychology; D002921:Cicatrix / Q000209:etiology / Q000628:therapy; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004338:Drug Combinations; D016527:Drug Costs; D005949:Glucose Oxidase / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D007784:Lactoperoxidase / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D009426:Netherlands; D010146:Pain / Q000209:etiology; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D011788:Quality of Life; D062326:Re-Epithelialization / Q000187:drug effects; D012107:Research Design; D012837:Silver Sulfadiazine / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D012867:Skin / Q000187:drug effects* / Q000473:pathology; D016038:Skin Transplantation; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*; D014946:Wound Infection / Q000382:microbiology / Q000628:therapy
chemical_list: D000464:Alginates; D000891:Anti-Infective Agents, Local; D004338:Drug Combinations; C000612382:Flaminal; D011092:Polyethylene Glycols; D005949:Glucose Oxidase; D007784:Lactoperoxidase; D012837:Silver Sulfadiazine