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A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation.

ABSTRACT: BACKGROUND:Scarring represents a significant biomedical burden in clinical medicine. Mechanomodulation has been linked to scarring through inflammation, but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible. METHODS:The authors conducted a 12-month, prospective, open-label, randomized, multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy device to reduce mechanical forces on healing surgical incisions. Incisions from 65 healthy adult subjects were randomized to receive embrace treatment on one half of an abdominoplasty incision and control treatment (surgeon's optimal care methods) on the other half. The primary endpoint for this study was the difference between assessments of scar appearance for the treated and control sides using the visual analogue scale scar score. RESULTS:Final 12-month study photographs were obtained from 36 subjects who completed at least 5 weeks of dressing application. The mean visual analogue scale score for embrace-treated scars (2.90) was significantly improved compared with control-treated scars (3.29) at 12 months (difference, 0.39; 95 percent confidence interval, 0.14 to 0.66; p = 0.027). Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale evaluation (p = 0.02 and p < 0.001, respectively). No serious adverse events were reported. CONCLUSIONS:These results demonstrate that the embrace device significantly reduces scarring following abdominoplasty surgery. To the authors' knowledge, this represents the first level I evidence for postoperative scar reduction. CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, II.

SUBMITTER: Longaker MT

PROVIDER: S-EPMC4425293 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation.

Longaker Michael T MT Rohrich Rod J RJ Greenberg Lauren L Furnas Heather H Wald Robert R Bansal Vivek V Seify Hisham H Tran Anthony A Weston Jane J Korman Joshua M JM Chan Rodney R Kaufman David D Dev Vipul R VR Mele Joseph A JA Januszyk Michael M Cowley Christy C McLaughlin Peggy P Beasley Bill B Gurtner Geoffrey C GC

Plastic and reconstructive surgery 20140901 3

<h4>Background</h4>Scarring represents a significant biomedical burden in clinical medicine. Mechanomodulation has been linked to scarring through inflammation, but until now a systematic approach to attenuate mechanical force and reduce scarring has not been possible.<h4>Methods</h4>The authors conducted a 12-month, prospective, open-label, randomized, multicenter clinical trial to evaluate abdominoplasty scar appearance following postoperative treatment with the embrace Advanced Scar Therapy d ...[more]

PMID: 24804638

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Project description:BackgroundReducing cutaneous scar formation is important for assessing the success of skin wound healing. Although it is generally accepted that adipose-derived mesenchymal stem cells (AMSCs) have substantial therapeutic potential, efforts are continuously made to improve the outcome of AMSC therapy. Post-transcriptional suppression of procollagen-lysine 1, 2-oxoglutarate 5-dioxygenase 1 (PLOD1) in AMSCs has been shown to greatly reduce scar formation during skin wound healing, likely through modulating macrophage polarization. In the present study, we tested whether a CD73+ subpopulation of AMSCs could reduce scar formation compared with CD73- AMSCs.MethodsThe gene profile of CD73+ versus CD73- AMSCs was obtained from a validated public database, GSE167219. AMSCs were isolated from adipose tissue surrounding the groin of mice, after which CD73+ versus CD73- AMSCs were sorted using flow cytometry. PLOD1 levels were determined in CD73+ versus CD73- AMSCs. Then, PLOD1 in CD73- AMSCs was depleted by a short-hair interfering RNA against PLOD1 (sh-PLOD1), while PLOD1 in CD73+ AMSCs was increased by expression of a PLOD1 transgene. A blade was used to induce a skin injury on the middle back of the mice. Either CD73+ AMSCs or CD73+ PLOD1 AMSCs or CD73- AMSCs or CD73- sh-PLOD1 AMSCs were intravenously transplanted into the injured region of the mice. Fibrosis and the underlying mechanisms were investigated. Co-immunoprecipitation was performed to evaluate interaction between CD73 and PLOD1.ResultsCD73+ AMSCs expressed significantly lower levels of PLOD1, a potent stimulator of fibrosis, compared with CD73- AMSCs. Transplantation of CD73+ AMSCs generated significantly reduced fibrosis at the skin injury site compared with CD73- AMSCs. However, expression of PLOD1 in CD73+ AMSCs abolished its advantageous effects on fibrosis reduction, while depletion of PLOD1 in CD73- AMSCs improved the outcome of fibrosis to the levels of transplantation of CD73+ AMSCs. Co-immunoprecipitation showed no direct protein interaction between CD73 and PLOD1.ConclusionsCD73+ AMSCs are a subgroup of AMSCs with better therapeutic effects on wound healing, and can inhibit scar formation through reduced PLOD1 in an indirect manner.

Project description:BackgroundNoninvasive ventilation (NIV), a form of positive airway pressure (PAP) therapy, is the standard of care for various forms of acute respiratory failure (ARF). Communication impairment is a side effect of NIV, impedes patient care, contributes to distress and intolerance, and potentially increases intubation rates. This study aimed to evaluate communication impairment during CPAP therapy and demonstrate communication device improvement with a standardized protocol.Research questionHow does an oronasal mask affect communication intelligibility? How does use of an NIV communication device change this communication intelligibility?Study design and methodsA single-center randomized controlled trial (36 outpatients with OSA on CPAP therapy) assessed exposure to CPAP 10 cm H2O and PAP communication devices (SPEAX, Ataia Medical). Communication impairment was evaluated by reading selected words and sentences for partners to record and were tabulated as %words correct. Each outpatient-partner pair performed three assessments: (1) baseline (conversing normally), (2) mask baseline (conversing with PAP), and (3) randomized to functioning device (conversing with PAP and device) or sham device. After each stage, both outpatients and partners completed Likert surveys regarding perceived intelligibility and comfort.ResultsWhile conversing with PAP, word and sentence intelligibility decreased relatively by 52% (87% vs 41%) and relatively by 57% (94% vs 40%), respectively, compared with normal conversation. Word and sentence intelligibility in the intervention arm increased relatively by 75% (35% vs 61%; P < .001) and by 126% (33% vs 76%; P < .001) higher than the control arm, respectively. The device improved outpatient-perceived PAP comfort relatively by 233% (15% vs 50%, P = .042) and partner-perceived comfort by relatively 245% (20% vs 69%, P = .0074).InterpretationUse of this PAP communication device significantly improves both intelligibility and comfort. This is one of the first studies quantifying communication impairment during PAP delivery.Trial registryClinicalTrials.gov; No.: NCT03795753; URL: www.clinicaltrials.gov.

Project description:BACKGROUND: Oral care is important for oral and systemic health, especially for elderly institutionalized individuals and compromised patients. However, conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration. Although antimicrobial photodynamic therapy (aPDT), which is considered an alternative or adjunct to mechanical approaches, has potential application as a less stressful method of daily plaque control, no clinical application of this technique has been reported. METHODS: We investigated the inhibitory effect of a combination of toluidine blue O (TBO), and a red light-emitting diode (LED) on dental plaque formation in healthy volunteers. The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells. To survey the mechanism of TBO-mediated aPDT, the quality and quantity of reactive oxygen species (ROS) generated during aPDT were also examined using electron spin resonance (ESR) spectroscopy. Subsequently, the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study. The right or left mandibular premolars were randomly assigned to the treatment (with aPDT) or control (without aPDT) groups. In total, aPDT was applied six times (twice per day) to the teeth in the test group over a period of four days. On the fourth day, the study concluded and the analyses were performed. RESULTS: A combination of 500 or 1000 ?g/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of Streptococcus oralis. The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity. Hydroxyl radicals were detected by ESR analysis, but singlet oxygen was not. A randomized controlled trial demonstrated that aPDT with 1000 ?g/ml TBO and red LED irradiation significantly suppressed dental plaque formation without harming teeth or the surrounding tissues. CONCLUSIONS: aPDT has the potential to be a promising novel technical modality for dental plaque control. TRIAL REGISTRATION: This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (number UMIN000012504).

Dataset Information

A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation.

Publications

A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation.

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