Cost-Effectiveness of a Nonpharmacological Intervention in Pediatric Burn Care.

OBJECTIVE: To report the cost-effectiveness of a tailored handheld computerized procedural preparation and distraction intervention (Ditto) used during pediatric burn wound care in comparison to standard practice. METHODS: An economic evaluation was performed alongside a randomized controlled trial of 75 children aged 4 to 13 years who presented with a burn to the Royal Children's Hospital, Brisbane, Australia. Participants were randomized to either the Ditto intervention (n = 35) or standard practice (n = 40) to measure the effect of the intervention on days taken for burns to re-epithelialize. Direct medical, direct nonmedical, and indirect cost data during burn re-epithelialization were extracted from the randomized controlled trial data and combined with scar management cost data obtained retrospectively from medical charts. Nonparametric bootstrapping was used to estimate statistical uncertainty in cost and effect differences and cost-effectiveness ratios. RESULTS: On average, the Ditto intervention reduced the time to re-epithelialize by 3 days at AU$194 less cost for each patient compared with standard practice. The incremental cost-effectiveness plane showed that 78% of the simulated results were within the more effective and less costly quadrant and 22% were in the more effective and more costly quadrant, suggesting a 78% probability that the Ditto intervention dominates standard practice (i.e., cost-saving). At a willingness-to-pay threshold of AU$120, there is a 95% probability that the Ditto intervention is cost-effective (or cost-saving) against standard care. CONCLUSIONS: This economic evaluation showed the Ditto intervention to be highly cost-effective against standard practice at a minimal cost for the significant benefits gained, supporting the implementation of the Ditto intervention during burn wound care.

Biological markers of stress in pediatric acute burn injury.

BACKGROUND: Burns and their associated wound care procedures evoke significant stress and anxiety, particularly for children. Little is known about the body's physiological stress reactions throughout the stages of re-epithelialization following an acute burn injury. Previously, serum and urinary cortisol have been used to measure stress in burn patients, however these measures are not suitable for a pediatric burn outpatient setting. AIM: To assess the sensitivity of salivary cortisol and sAA in detecting stress during acute burn wound care procedures and to investigate the body's physiological stress reactions throughout burn re-epithelialization. METHODS: Seventy-seven participants aged four to thirteen years who presented with an acute burn injury to the burn center at the Royal Children's Hospital, Brisbane, Australia, were recruited between August 2011 and August 2012. RESULTS: Both biomarkers were responsive to the stress of burn wound care procedures. sAA levels were on average 50.2 U/ml higher (p<0.001) at 10 min post-dressing removal compared to baseline levels. Salivary cortisol levels showed a blunted effect with average levels at ten minutes post dressing removal decreasing by 0.54 nmol/L (p<0.001) compared to baseline levels. sAA levels were associated with pain (p=0.021), no medication (p=0.047) and Child Trauma Screening Questionnaire scores at three months post re-epithelialization (p=0.008). Similarly, salivary cortisol was associated with no medication (p<0.001), pain scores (p=0.045) and total body surface area of the burn (p=0.010). CONCLUSION: Factors which support the use of sAA over salivary cortisol to assess stress during morning acute burn wound care procedures include; sensitivity, morning clinic times relative to cortisol's diurnal peaks, and relative cost.

Predictors of re-epithelialization in pediatric burn.

INTRODUCTION: An important treatment goal for burn wounds is to promote early wound closure. This study identifies factors associated with delayed re-epithelialization following pediatric burn. METHODS: Data were collected from August 2011 to August 2012, at a pediatric tertiary burn center. A total of 106 burn wounds were analyzed from 77 participants aged 4-12 years. Percentage of wound re-epithelialization at each dressing change was calculated using Visitrak™. Mixed effect regression analysis was performed to identify the demographic factors, wound and clinical characteristics associated with delayed re-epithelialization. RESULTS: Burn depth determined by laser Doppler imaging, ethnicity, pain scores, total body surface area (TBSA), mechanism of injury and days taken to present to the burn center were significant predictors of delayed re-epithelialization, accounting for 69% of variance. Flame burns delayed re-epithelialization by 39% compared to all other mechanisms (p = 0.003). When initial presentation to the burn center was on day 5, burns took an average of 42% longer to re-epithelialize, compared to those who presented on day 2 post burn (p < 0.000). Re-epithelialization was delayed by 14% when pain scores were reported as 10 (on the FPS-R), compared to 4 on the first dressing change (p = 0.015) for children who did not receive specialized preparation/distraction intervention. A larger TBSA was also a predictor of delayed re-epithelialization (p = 0.030). Darker skin complexion re-epithelialized 25% faster than lighter skin complexion (p = 0.001). CONCLUSIONS: Burn depth, mechanism of injury and TBSA are always considered when developing the treatment and surgical management plan for patients with burns. This study identifies other factors influencing re-epithelialization, which can be controlled by the treating team, such as effective pain management and rapid referral to a specialized burn center, to achieve optimal outcomes.

Play and heal: randomized controlled trial of Ditto™ intervention efficacy on improving re-epithelialization in pediatric burns.

BACKGROUND: The relationships between pain, stress and anxiety, and their effect on burn wound re-epithelialization have not been well explored to-date. The aim of this study was to investigate the effect of the Ditto™ (a hand-held electronic medical device providing procedural preparation and distraction) intervention on re-epithelialization rates in acute pediatric burns. METHODS/DESIGN: From August 2011 to August 2012, children (4-12 years) with an acute burn presenting to the Royal Children's Hospital, Brisbane, Australia fulfilled the study requirements and were randomized to [1] Ditto™ intervention or [2] standard practice. Burn re-epithelialization, pain intensity, anxiety and stress measures were obtained at every dressing change until complete wound re-epithelialization. RESULTS: One hundred and seventeen children were randomized and 75 children were analyzed (n=40 standard group; n=35 Ditto™ group). Inability to predict wound management resulted in 42 participants no longer meeting the eligibility criteria. Wounds in the Ditto™ intervention group re-epithelialized faster than the standard practice group (-2.14 days (CI: -4.38 to 0.10), p-value=0.061), and significantly faster when analyses were adjusted for mean burn depth (-2.26 days (CI: -4.48 to -0.04), p-value=0.046). Following procedural preparation at the first change of dressing, the Ditto™ group reported lower pain intensity scores (-0.64 (CI: -1.28, 0.01) p=0.052) and lower anxiety ratings (-1.79 (CI: -3.59, 0.01) p=0.051). At the second and third dressing removals average pain (FPS-R and FLACC) and anxiety scores (VAS-A) were at least one point lower when Ditto™ intervention was received. CONCLUSIONS: The Ditto™ procedural preparation and distraction device is a useful tool alongside pharmacological intervention to improve the rate of burn re-epithelialization and manage pain and anxiety during burn wound care procedures.

Efficacy of a children's procedural preparation and distraction device on healing in acute burn wound care procedures: study protocol for a randomized controlled trial.

BACKGROUND: The intense pain and anxiety triggered by burns and their associated wound care procedures are well established in the literature. Non-pharmacological intervention is a critical component of total pain management protocols and is used as an adjunct to pharmacological analgesia. An example is virtual reality, which has been used effectively to dampen pain intensity and unpleasantness. Possible links or causal relationships between pain/anxiety/stress and burn wound healing have previously not been investigated. The purpose of this study is to investigate these relationships, specifically by determining if a newly developed multi-modal procedural preparation and distraction device (Ditto™) used during acute burn wound care procedures will reduce the pain and anxiety of a child and increase the rate of re-epithelialization. METHODS/DESIGN: Children (4 to 12 years) with acute burn injuries presenting for their first dressing change will be randomly assigned to either the (1) Control group (standard distraction) or (2) Ditto™ intervention group (receiving Ditto™, procedural preparation and Ditto™ distraction). It is intended that a minimum of 29 participants will be recruited for each treatment group. Repeated measures of pain intensity, anxiety, stress and healing will be taken at every dressing change until complete wound re-epithelialization. Further data collection will aid in determining patient satisfaction and cost effectiveness of the Ditto™ intervention, as well as its effect on speed of wound re-epithelialization. DISCUSSION: Results of this study will provide data on whether the disease process can be altered by reducing stress, pain and anxiety in the context of acute burn wounds. TRIAL REGISTRATION: ACTRN12611000913976.