BackgroundSevere burn injuries result in relevant restrictions of physical capacity as well as psychological and social integrity and require a specialized rehabilitation. There is a common agreement, among national as well as international burn associations, that burn rehabilitation is a complex, dynamic process which needs an interdisciplinary and specialized treatment team. There is wide agreement that more research is needed in this field.Methods/designThe aim of the study is to examine the effectiveness and efficiency of our new ICF (International Classification of Functioning, Disability and Health)-based rehabilitation for thermal injuries. Because of ethical reasons, we have chosen a prospective non-randomized design, which takes place at two different rehabilitation centers. At center A, a newly developed ICF-based rehabilitation program was established; at rehabilitation center B, a well-established rehabilitation program has existed for 20 years and is used as reference. The primary research question addresses the “Pre-post comparison of the physical and psychological outcome measurements,” secondary question I looks at the “Examination of the non-inferiority of the new treatment concept with the established concept,” and secondary question II is the “Analysis of the rehabilitation process based on the rehabilitation cycle.”Only patients of the two burn rehabilitation centers who are insured by workers’ compensation will be asked to participate in this study to avoid outcome bias by insurance status. A physical examination (physical working capacity testing, grip strength, range of motion, and scar evaluation by Cutometer and Vancouver Scar Scale) and a standardized questionnaire battery (Burn Specific Health Scale-Brief , Short Form 36, Impact of Event Scale-Revised, the German version of the Symptom Checklist, the Freiburg Social Support Questionnaire, Patient/Client Satisfaction Questionnaire, Disabilities of the Arm, Shoulder and Hand, and Lower Extremity Functional Scale ) measure physical and psychological conditions. Data will be taken on admission, during stay, and on discharge of the rehabilitation program and at follow-up 3 and 12 months after discharge. A minimum of 162 participants will be enrolled in this clinical longitudinal, prospective, observational study.DiscussionThe proof of the effectiveness of the ICF-based rehabilitation program for thermal injuries will give evidence in a comprehensive way for the first time in this field. As result, a standardized rehabilitation concept will be introduced, which can be provided to other rehabilitation institutions treating thermal injuries.Trial registrationGerman Clinical Trials Register, DRKS00017702. Registered on 2 September 2019.
An objective burn scar assessment is essential to informed therapeutic decision making and to monitor scar development over time. However, widely employed scar rating scales show poor inter-rater reliability. For this study we developed a standardized measurement protocol for the Cutometer © applicable for objective burn scar assessment in everyday clinical practice. We developed a measurement protocol for the Cutometer © MPA 580 including a scar site relocation technique based on anatomical landmarks. The protocol emerged through several steps: Identifying key factors for valid and reliable measurements, preliminary testing, specification of technical details, refining the protocol and final testing. Consecutively, the protocol was validated for inter-rater reliability by assessing 34 burn scars in 17 patients by four clinicians and computing an Intraclass Correlation Coefficient (ICC). Parameter R0, representing scar pliability, was identified as the best suited output parameter yielding excellent inter-rater reliability for average measures (ICC 0.92 [95% CI 0.86;0.96]) and acceptable reliability for single measures (ICC: 0.74 [0.61;0.84]). The pressure applied on the measuring probe was identified as an influential confounding factor for reliable measurements. Rater gender did not influence reliability of measurements. The introduced standardized measurement protocol for the Cutometer © MPA 580 enables an objective and reliable burn scar assessment for clinical as well as research purposes.
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