Within-Patient, Single-Blinded, Randomized Controlled Clinical Trial to Evaluate the Efficacy of Triamcinolone Acetonide Injections for the Treatment of Hypertrophic Scar in Adult Burn Survivors.

Intralesional corticosteroid (triamcinolone acetonide [TAC]) injections have become one of the cornerstone treatments of hypertrophic scar (HSc). However, the evidence is of limited-quality, and published investigations have almost exclusively been performed in linear scars rather than hypertrophic burn scars. Thus, the aim of this study was to perform an appropriately powered, single-blinded, randomized controlled trial to evaluate the impact of TAC injections on burn HSc compared with patient-matched usual care control scars. Fifty burn survivors with two scars (separated by nonscarred skin preferably on the contralateral side or an anatomically similar site) were selected based on high-frequency ultrasound thickness (>2.034 mm to ensure that the site was outside of the range of normal scar). Pretreatment thickness measurements of the two sites were within 0.5 mm of each other, to ensure homogeneity and an erythema index >300 to establish they were immature HSc. The sites were randomly assigned to treatment or control. The treatment HSc received a 10 mg/ml TAC. When necessary, the injection was repeated after 6 weeks and a third final injection 6 weeks later. Objective evaluation of thickness, elasticity, erythema, and melanin was obtained at the treatment and control sites at pretreatment, posttreatment, and follow-up 6 weeks after the last injection. Thirty participants completed the study, reaching the required number for an adequately powered sample based on pilot study data analyses. Ten participants received only one injection, 27 received only two injections, and 13 received three injections of TAC. Analysis of covariance comparing the treatment vs control HSc posttreatment, controlling for pretreatment values and Fitzpatrick skin type, revealed a significant decrease in thickness and increase in elasticity of the treated compared with control HSc (P = .0003), but no significant difference in erythema or melanin. Pretreatment to posttreatment comparisons using paired t-tests revealed a significant decrease in thickness of both the treated and control HSc, an increase in elasticity of the treated HSc during the treatment period, but no significant change in the control HSc elasticity or erythema of either site, and a significant increase in melanin of both the treated (P < .001) and control (P = .02) HSc. A regression model for repeated measures, controlling for pretreatment values and skin type, revealed no significant change in thickness, elasticity, erythema, or melanin during the 6-week follow-up. Although thickness decreased at both the treated and control HSc across time, there was a significantly greater reduction at the TAC injected HSc and a significantly greater increase in elasticity. Melanin significantly increased at both the treatment and control site. There was no significant change during the follow-up period of any of the HSc characteristics.

Longitudinal Evaluation of Pressure Applied by Custom Fabricated Garments Worn by Adult Burn Survivors.

Custom fabricated pressure garments (PGs) are commonly used to prevent or treat hypertrophic scars (HSc) after burn injury. However, there is minimal scientific evidence quantifying pressure after standard measurement and fitting techniques. Adult burn survivors whose HSc was treated with PGs were recruited. Trained fitters, blinded to study locations and results, took the garment measures. Once the PGs arrived and were fitted, baseline pressure measures at HSc and normal skin (NS) sites were determined using the Pliance X® System. Pressure readings were repeated at 1, 2, and 3 months. The mean baseline pressure was 15.3 (SD 10.4) at HSc and 13.4 (SD 11.9) at NS sites. There was a significant reduction during the first month at both sites (P = .0002 HSc; P = .0002 NS). A multivariable linear regression mixed model, adjusting for garment type, baseline pressure, and repeated measures, revealed further reduction at HSc sites between 1 and 2 months (P = .03). By 3 months, the mean pressure reduced to 9.9 (SD 6.7) and 9.15 (SD 7.2) mm Hg at HSc and NS sites, respectively. At each time point, the pressure was higher at HSc compared with NS but was significantly different only at 1 month (P = .01). PGs were worn ≥12 hr/d 7 d/wk. PGs that apply 15 to 25 mm Hg pressure significantly improve HSc; however, immediately after fitting newly fabricated PGs, the average pressure was at the bottom of the recommended range and by 1 month was significantly below. Clinicians are likely underestimating the dosage required and the significant pressure loss within the first 2 months.

Perceived Value of a Knowledge Translation Intervention Designed to Facilitate Burn Survivors' Work Reintegration.

Returning to work can be challenging for burn survivors. Approximately 28% never return to any form of employment, resulting in lower health-related quality of life. Open communication has been identified as a facilitator for return to work (RTW). To ease the RTW process and promote communication with coworkers and employers a knowledge translation (KT) intervention was developed for burn survivors. Following its implementation, the impact on the RTW process was evaluated. This study was a cross-sectional, mixed methods study where burn survivors included in the KT intervention were compared with a control group. Control group participants were selectively invited so that the two groups' mean age, sex, and percent total body surface area burned were similar. Semistructured interviews gathered information about their RTW process and outcomes. Qualitative data were analyzed through thematic analysis and quantitative data were summarized and compared using Mann-Whitney tests. Overall, both groups were satisfied with their RTW process. Participants from the control group identified more barriers related to support received, particularly at work, and reported more psychological symptoms such as posttraumatic stress disorder, self-consciousness, and discomfort with questions. Many participants from the KT group indicated the KT intervention gave them tools and information to provide others with a better understanding of their lived experience. It is possible that the KT intervention facilitated more open communication by empowering burn survivors to explain their situation on their own, thus reducing the prevalence of social and psychological barriers by allowing them to self-advocate for more support.

Randomized controlled trial of the immediate and long-term effect of massage on adult postburn scar.

BACKGROUND: One objective of massage therapy applied to hypertrophic scar (HSc), is to improve the structural properties so skin possesses the strength and elasticity required for normal mobility. However, research supporting this effect is lacking. The objective of this study was to characterize the changes in scar elasticity, erythema, melanin, and thickness immediately after a massage therapy session and after a 12-week course of treatment compared to intra-individual matched control scars. METHODS: We conducted a prospective, randomized, single-blinded, pragmatic, controlled, clinical trial evaluating the impact of a 12-week course of massage therapy. Seventy burn survivors consented to participate and 60 completed the study. Two homogeneous, intra-individual scars were randomized to usual care control or massage therapy plus usual care. Massage, occupational or physical therapists provided massage treatment 3x/week for 12 weeks. Scar site characteristics were evaluated weekly immediately before and after massage treatment including elasticity (Cutometer), erythema and melanin (Mexameter), and thickness (high-frequency ultrasound). Analysis of covariance (ANCOVAs) were performed to test for immediate and long-term treatment effects. A mixed-model approach was used to account for the intra-individual scars. RESULTS: Scar evaluation immediately before and after massage therapy at each time point revealed changes for all scar characteristics, but the group differences were predominantly present during the early weeks of treatment. The within group long-term analysis revealed a significant increase in elasticity, and a reduction in thickness, during the 12-week treatment period for both the control scar (CS) and massage scar (MS). The increase in elasticity reached significance at week 8 for the MS and week 10 for the CS and the reduction in thickness at week 5 for the CS and week 7 for the MS. There was no significant within group long-term differences for either erythema or melanin. There were group differences in erythema at week 8 and 11 where the CS was less erythematous than the MS. CONCLUSIONS: The immediate impact of forces applied during massage therapy may lead patients and therapists to believe that there are long-term changes in elasticity, erythema, and pigmentation, however, once baseline measures, the control scar, and time were incorporated in the analysis there was no evidence of long-term benefit. Massage therapy applied with the objective of increasing scar elasticity or reducing erythema or thickness over the long-term should be reconsidered.

Postburn Itch: A Review of the Literature.

The problem of postburn itch has been underevaluated and undertreated in the past. However, recently published data have expanded the evidence base, which provides clinicians and their patients with new evaluation and treatment options that can help reduce and potentially eliminate the prolonged distress experienced by burn survivors faced with postburn itch. Although a gold standard evaluation method has not yet been agreed upon, there are a number of tools that have been published that clinicians can use for assessment. Epidemiological evidence has confirmed that the vast majority of both adult and pediatric burn survivors experience itch for years following injury. At discharge from the acute care hospital, 93% of burn survivors with major burn injuries report postburn itch that is still experienced by 44% of adult burn survivors 30 years postburn. Although larger surface area injuries are more likely to require a multimodal treatment approach to reduce the itch intensity as well as the episode duration and frequency, burn survivors with small surface area injuries also experience itch that needs to be addressed. A number of treatment protocols have been described that commonly call for concurrent administration of both pharmacological and nonpharmacological treatment approaches. These protocols provide clinicians with a structured, systematic approach to treatment decisions that are evidence-based. Although many questions require further investigation, the current state of the science creates an ethical imperative that all burn survivors' itch experience should be quantitatively evaluated and appropriate treatment options explored until satisfactory outcomes are obtained.

Development and clinimetric evaluation of the mouth impairment and disability assessment (MIDA).

INTRODUCTION: Burns of the face and mouth region have a profound impact on function. Currently the outcome measure that is most commonly used in the burn care literature is horizontal and vertical opening. Impairment-based outcomes such as this do not capture the functional implications of these injuries in spite of the devastating impact they can have on burn survivor's lives. PURPOSE OF THE STUDY: To generate an assessment that evaluates the impairments, activity limitations, and participation restrictions associated with mouth injuries and prospectively collect data to examine the clinimetric properties. METHODS: A multistep assessment development process was undertaken including a comprehensive literature search and review, burn care expert and burn survivor interviews, generation of a preliminary version and field-testing, modifications based on field testing and updated literature review, and further field testing with data collection of 23 burn survivors. Clinimetric properties were examined by evaluating: whether there was a ceiling or floor effect, the internal consistency, construct validity, and responsiveness. RESULTS: The mouth impairment and disability assessment (MIDA) has a 28 item self-report portion, divided into four subscales, completed by the patient and an impairment-based section completed by the burn therapist. Two items demonstrated a ceiling effect, one was removed the other retained. There was strong and statistically significant (p<0.0001) correlation of the symptoms subscale as well as vertical opening with the functional activities subscale of the MIDA. The functional activities subscale demonstrated good internal consistency and the symptoms subscale was adequate. Re-evaluation approximately seven and a half months after the baseline evaluation demonstrated a statistically significant change with time and treatment. CONCLUSIONS: The MIDA now offers clinicians the ability to assess mouth impairment and disability of burn survivors who have sustained burn injuries to their face and mouth region.

Somatosensory Rehabilitation for Neuropathic Pain in Burn Survivors: A Case Series.

Neuropathic pain is an enormous rehabilitation challenge that has a substantial negative effect on patient function and quality of life. Somatosensory rehabilitation is a novel, nonpharmacological intervention described by Spicher based on the neuroplasticity of the somatosensory system. The rationale for somatosensory rehabilitation is that treating hypoesthesia will decrease neuropathic pain. Particularly for those with established neuropathic pain, the hypoesthesia may be masked by mechanical allodynia, which must be treated before treating the underlying hyposensitive zone. This case series describes the outcome of 17 burn survivors treated with somatosensory rehabilitation for their neuropathic pain. Before initiating treatment a modified version of the McGill Pain Questionnaire-short form (Questionnaire de la douleur St. Antoine, QDSA) was completed with the patients. The total score (×/64) was converted to percentage. The mechanical allodynia was assessed with the Rainbow Pain Scale that uses touch with the 15-g Semmes Weinstein Monofilaments (SWMs) and that was rated as painful on the visual analog scale (3/10 or resting pain + 1/10), as the criteria for mechanical allodynia. The severity level was assessed using seven predetermined SWMs to identify the smallest that elicited pain. The treatment consisted of avoiding all touch in the allodynic zone while concurrently providing proximal sensory and vibratory counter stimulation. Once the mechanical allodynia was eliminated, the underlying hypoesthesia was treated. Hypoesthesia was evaluated with the SWMs, and the percent improvement from baseline was calculated. The sensory reeducation treatment for hypoesthesia consisted of touch discrimination, texture perception, and vibratory stimulation. Seventeen patients (71/29% male/female, 21 ± 25% TBSA burned, 486 ± 596 days postburn) were evaluated and treated. Of these 15 initially presented with mechanical allodynia. The SWM scores had improved by 27 ± 21% (n = 14) and 29 ± 26% (n = 12) at 2 and 3 months posttreatment, respectively. The QDSA scores had improved by 9 ± 14% (n = 8) and 23 ± 23% (n = 6) at 2 and 3 months posttreatment, respectively. There were two patients who initially presented with hypoesthesia and six who had their zone of hypoesthesia treated after the mechanical allodynia had resolved. For these eight patients, their ability to perceive light touch improved by 27 ± 17% (n = 8) and 35 ± 25% (n = 6) at 2 and 3 months postsensory reeducation treatment initiation, respectively. The QDSA improved by 9 and 50% for the two patients who initially presented with hypoesthesia. In this case series, the majority of patients (13/17 or 76%) showed substantial improvements after somatosensory rehabilitation suggesting this is a treatment approach that should be considered with burn survivors experiencing neuropathic pain. There is a need, however, for future controlled studies to further investigate this approach and to determine if there is a subpopulation of burn survivors that are more likely than others to benefit from this approach.

Longitudinal burn scar quantification.

Quantitative studies of the clinical recovery of burn scars are currently lacking. Previous reports validate the objective, precise, diagnostic capabilities of high-frequency ultrasound to measure thickness, the Cutometer(®) to measure pliability and the Mexameter(®) to measure erythema and pigmentation of scars. Thus, we prospectively quantified clinical characteristics of patient-matched, after burn hypertrophic scar (HSc), donor site scar (D) and normal skin (N) using these instruments. One investigator measured 3 sites (HSc, D, N) in 46 burn survivors at 3, 6, and 12 months after-burn. A mixed model regression analysis, adjusting p-values for multiplicity of testing, was used to compare means among sites and time points. Participants were 41.2±13.5 years old, 87% males, predominantly Caucasian, with an average of 19.5% body surface area burned. HSc thickness decreased significantly between 3 and 6, 6 and 12, and 3 and 12 months (all p<0.0001), but remained thicker than D and N skin (all p<0.0001). Pliability differed significantly between HSc, D and N sites at all time points (all p<0.0001), with HSc and D increasing between 3 and 12 months (p<0.05) but not reaching normal. HSc and D sites were significantly more erythematous than normal skin (p<0.05) at 3 and 6 months but D sites approached normal by 12 months. The only time points at which pigmentation significantly differed were the HSc and D sites at 6 months. Thickness, pliability, erythema and pigmentation of N skin remained similar over the 12 months. We found that post-burn HSc thickness, pliability and erythema differed significantly from D and N skin at 3, 6, and 12 months and does not return to normal by 12 months after-injury; however, significant improvements towards normal can be expected. Donor sites are redder than normal skin at 3 and 6 months but can be expected to return to normal by 12 months. Although the color of HSc and D sites change markedly with time these color changes are primarily due to changes in redness of the site, not melanin in this primarily Caucasian population.

Assessment of pruritus characteristics and impact on burn survivors.

The goal of this cross-sectional study was to characterize and describe persistent postburn pruritus. Cause and treatment of postburn itch is elusive. It has been suggested that burn survivors with persistent pruritus should be divided into acute itch (≤6 months postinjury) and chronic itch (>6 months postinjury) because the cause of itch may be different. Cross-sectional data of itch characteristics reported here are from the baseline data of a prospective, randomized, double-blind, controlled pilot study of 23 subjects with frequent and bothersome postburn pruritus. Subjects self-completed validated scales for variables of itch sensation, affect of itch, and severity. Variables of quality of life, frequency, pain and itch intensity, skin condition, scar, and medication were also recorded. Itch frequency revealed that 87% of subjects experienced itching daily, 96% experienced three or more episodes a day, and 52% had episode durations lasting 5 to 30 minutes per incidence. Itch was reported as unbearable by 94% of subjects with chronic itch and by 86% of subjects with acute itch, whereas bothersome was 88 and 100%, respectively. Itch sensation dimension of stinging was 74% in both acute and chronic itch subjects. Crawling and burning sensations were often severe. Potential itch triggers and relief activities were identified. Differences in sensory and affective itch components were detected between acute and chronic itch subjects. Combinations of itch mechanisms probably contribute to the development of and changes in pruritus. Characterizing the sensation and affective itch dimensions in conjunction with inflammation, burn injury, recovery, scar maturation, medication, and psychological status should better elucidate postburn itch.

Double-blind, randomized, pilot study assessing the resolution of postburn pruritus.

The objective of this study was to evaluate whether Provase®, a nonprescription moisturizer with a blend of protease enzymes, would reduce postburn itching in adult burn survivors relative to a control moisturizer. This was a prospective, single-center, double-blinded, pilot study where 23 burn survivors were randomized to either the treatment group, who applied Provase, or the control group, who applied the base moisturizer used in Provase every 8 hours for 4 weeks. Twelve were randomized to the treatment and 11 to the control groups with 9 participants in each group completing the study. There was no difference between groups with respect to gender, ethnicity, causative factor, TBSA burned, or time postinjury. Participant's pruritus and scar were reevaluated on a weekly basis for 4 consecutive weeks. Relative to baseline, there was a significant reduction of itch duration in minutes at weeks 3 and 4, the number of days per week that itch was experienced at weeks 2, 3, and 4, and the number of itch episodes per day at week 2 for the treatment group. The itch TBSA reduced significantly relative to baseline for the treatment group at week 1, 2, and 3. The affective itch characteristics were significantly reduced for the treatment group for bothersome at weeks 1, 2, 3, and 4; for annoying at week 4; and for unbearable at weeks 2, 3, and 4. Although this was a pilot study and not powered for statistical differences, there were statistically significant differences for itch duration, weekly frequency, itch episodes per day, itch TBSA, and reported affective burden of itch after treatment. Further investigation is recommended with a larger sample size treated for a longer period of time where participants are stratified based on acute or chronic itch.

Quantitative measurement of hypertrophic scar: interrater reliability and concurrent validity.

Research into the pathophysiology and treatment of hypertrophic scar (HSc) remains limited by the heterogeneity of scar and the imprecision with which its severity is measured. The objective of this study was to test the interrater reliability and concurrent validity of the Cutometer measurement of elasticity, the Mexameter measurement of erythema and pigmentation, and total thickness measure of the DermaScan C relative to the modified Vancouver Scar Scale (mVSS) in patient-matched normal skin, normal scar, and HSc. Three independent investigators evaluated 128 sites (severe HSc, moderate or mild HSc, donor site, and normal skin) on 32 burn survivors using all of the above measurement tools. The intraclass correlation coefficient, which was used to measure interrater reliability, reflects the inherent amount of error in the measure and is considered acceptable when it is >0.75. Interrater reliability of the totals of the height, pliability, and vascularity subscales of the mVSS fell below the acceptable limit ( congruent with0.50). The individual subscales of the mVSS fell well below the acceptable level (< or =0.3). The Cutometer reading of elasticity provided acceptable reliability (>0.89) for each study site with the exception of severe scar. Mexameter and DermaScan C reliability measurements were acceptable for all sites (>0.82). Concurrent validity correlations with the mVSS were significant except for the comparison of the mVSS pliability subscale and the Cutometer maximum deformation measure comparison in severe scar. In conclusion, the Mexameter and DermaScan C measurements of scar color and thickness of all sites, as well as the Cutometer measurement of elasticity in all but the most severe scars shows high interrater reliability. Their significant concurrent validity with the mVSS confirms that these tools are measuring the same traits as the mVSS, and in a more objective way.

Quantitative measurement of hypertrophic scar: intrarater reliability, sensitivity, and specificity.

The comparison of scar evaluation over time requires measurement tools with acceptable intrarater reliability and the ability to discriminate skin characteristics of interest. The objective of this study was to evaluate the intrarater reliability and sensitivity and specificity of the Cutometer, the Mexameter, and the DermaScan C relative to the modified Vancouver Scar Scale (mVSS) in patient-matched normal skin, normal scar (donor sites), and hypertrophic scar (HSc). A single investigator evaluated four tissue types (severe HSc, less severe HSc, donor site, and normal skin) in 30 burn survivors with all four measurement tools. The intraclass correlation coefficient (ICC) for the Cutometer was acceptable (> or =0.75) for the maximum deformation measure for the donor site and normal skin (>0.78) but was below the acceptable range for the HSc sites and all other parameters. The ICC for the Mexameter erythema (>0.75) and melanin index (>0.89) and the DermaScan C total thickness measurement (>0.82) were acceptable for all sites. The ICC for the total of the height, pliability, and vascularity subscales of the mVSS was acceptable (0.81) for normal scar but below the acceptable range for the scar sites. The DermaScan C was clearly able to discriminate HSc from normal scar and normal skin based on the total thickness measure. The Cutometer was less discriminating but was still able to discriminate HSc from normal scar and normal skin. The Mexameter erythema index was not a good discriminator of HSc and normal scar. Receiver operating characteristic curves were generated to establish the best cutoff point for the DermaScan C total thickness and the Cutometer maximum deformation, which were 2.034 and 0.387 mm, respectively. This study showed that although the Cutometer, the DermaScan C, and the Mexameter have measurement properties that make them attractive substitutes for the mVSS, caution must be used when interpreting results since the Cutometer has a ceiling effect when measuring rigid tissue such as HSc and the Mexameter erythema index does not discriminate normal scar from HSc.