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.

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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Netherlands Trial Register NTR4486 , registered on 2 April 2014.

Skin stretching for primary closure of acute burn wounds.

BACKGROUND: In burn care, a well-acknowledged problem is the suboptimal scar outcome from skin grafted burn wounds. With the aim of improving this, we focused on a new technique: excision of the burn wound followed by primary closure, thereby using a skin-stretching device to stretch the adjacent healthy skin. The short- and long-term effect of Skin Stretch was compared to split skin grafting (SSG) in a randomized controlled trial. METHODS: Patients with burn wounds were randomized for SSG or primary wound closure using Skin Stretch. Follow-up was performed at 3 and 12 months postoperatively. The scar surface area was calculated and the scar quality was assessed, using subjective and objective measurement methods. RESULTS: No significant differences between the SSG and the Skin Stretch group were found for scar surface area. In the Skin Stretch group, a significant reduction of the surface area from 65.4cm(2) (13.6-129.1) to 13.4cm(2) (3.0-36.6) was found at 3 months (p=0.028) and at 12 months postoperatively (65.4cm(2) (13.6-129.1) to 33.0cm(2) (8.9-63.7), p=0.046, Wilcoxon signed ranks test). CONCLUSIONS: Skin Stretch for primary closure of acute burn wounds is a suitable technique and can be considered for specific circumscript full-thickness burn wounds. However, future research should be performed to provide additional scientific evidence.

The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation.

At present, various scar assessment scales are available, but not one has been shown to be reliable, consistent, feasible, and valid at the same time. Furthermore, the existing scar assessment scales appear to attach little weight to the opinion of the patient. The newly developed Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively. The patient scale's consistency and the observer scale's consistency, reliability, and feasibility were tested. For the Vancouver Scar Scale, which is the most frequently used scar assessment scale at present, the same statistical measurements were examined and the results of the observer scale and the Vancouver scale were compared. The concurrent validity of the observer scale was tested with a correlation to the Vancouver scale. Furthermore, the authors examined which specific characteristics significantly influence the general opinion of the patient and the observers on the scar areas. Four independent observers have each used the observer scale and the Vancouver scale to assess 49 burn scar areas of 3 x 3 cm belonging to 20 different patients. Subsequently, the patients completed the patient scale for their scar areas. The (internal) consistency of both the patient and the observer scales was acceptable (Cronbach's alpha, 0.76 and 0.69, respectively), whereas the consistency of the Vancouver scale appeared not to be acceptable (alpha, 0.49). The reliability of the observer scale completed by a single observer was acceptable (r = 0.73). The reliability of the Vancouver scale completed by a single observer was lower (r = 0.69). The observer scale showed better agreement than the Vancouver scale because the coefficient of variation was lower (18 percent and 22 percent, respectively). The concurrent validity of the observer scale in relation to the Vancouver scale is high (r = 0.89, p < 0.001). Linear regression of the general opinions on scars of the observer and the patient showed that the observer's opinion is influenced by vascularization, thickness, pigmentation, and relief, whereas the patient's opinion is mainly influenced by itching and the thickness of the scar. Such an impact of itching and thickness of the scar on the patient's opinion is an important and novel finding. The Patient and Observer Scar Assessment Scale offers a suitable, reliable, and complete scar evaluation tool.

Colour evaluation in scars: tristimulus colorimeter, narrow-band simple reflectance meter or subjective evaluation?

The evaluation of scar colour is, at present, usually limited to an assessment according to a scar assessment scale. Although useful, these assessment scales only evaluate subjectively the degree of scar colour. In this study, the reliability of the subjective assessment of scar colour by observers is compared to the reliability of the measurements of two objective colour measurement instruments. Four independent observers subjectively assessed the vascularisation and pigmentation of 49 scar areas in 20 patients. The degree of vascularisation and pigmentation was scored according to a scale ranging from '1', when it appeared to be like healthy skin, to '10', which corresponds to the worst imaginable outcome of vascularisation or pigmentation. The observers also scored the pigmentation categories of the scar (hypopigmention, hyperpigmention or mixed pigmentation). Finally, each observer measured the scar areas with a tristimulus colorimeter (Minolta Chromameter) and a narrow-band simple reflectance meter (DermaSpectrometer). A single observer could reliably carry out measurements of the DermaSpectrometer and the Minolta Chromameter for the evaluation of scar colour (r = 0.72). The vascularisation of scars could also be assessed reliably with a single observer (r = 0.76) whereas for a reliable assessment of pigmentation at least three observers were necessary (r > or = 0.77). The agreement between the observers for the pigmentation categories also turned out to be unacceptably low (k = 0.349). This study shows that an overall evaluation of scar colour with the DermaSpectrometer and the Minolta Chromameter is more reliable than the evaluation of scar colour with observers. Of both instruments for measuring scar colour, we prefer, because of its feasibility, the DermaSpectrometer.

Skin elasticity meter or subjective evaluation in scars: a reliability assessment.

UNLABELLED: Various methods are available for evaluating the elasticity of scars. However, the reliability and validity of these methods have been sparsely examined. The aim of this study was to examine the reliability of the subjective evaluation of scar pliability, while at the same time testing the reliability of the measurements of a non-invasive suction device (Cutometer Skin Elasticity Meter 575) on scars. Four observers assessed 49 scar areas of 20 patients with a subjective assessment of pliability. Subsequently, each observer measured the scar areas with the Cutometer. The intraclass correlation coefficients (ICC) of the elasticity (Ue) and extension (Uf) parameters of the Cutometer were acceptable (r = 0.76 and 0.74, respectively) when a single observer carried out the measurements. The subjective assessment of pliability needs to be completed by two or more observers to make the evaluation reliable (r = 0.79). The concurrent validities between the subjective pliability-assessment and each of the Cutometer parameters were statistically significant and ranged from r = 0.29-0.53. The correlations between each of the Cutometer parameters were high and statistically significant (r > or = 0.71). CONCLUSION: A single observer can reliably use the Cutometer for the elasticity measurements of scars. Furthermore, either Ue or Uf, instead of all five elasticity values provided by the Cutometer, can be adequately used for the elasticity measurements of scars. The subjective assessment of pliability of scars can only be assessed reliably when completed by two or more observers. The concurrent validity showed that all Cutometer parameters, except for visco-elasticity (Uv), and the subjective assessment of pliability measured the same characteristic of a scar.