A 1-Year Follow-Up of Post-operative Scars After the Use of a 1210-nm Laser-Assisted Skin Healing (LASH) Technology: A Randomized Controlled Trial.

BACKGROUND: Laser therapies are used prophylactically for excessive scar formation. The Laser-Assisted Skin Healing treatment induces a controlled heat stress that promotes tissue regeneration. This comparative trial is the first to evaluate the performance of a new automated 1210-nm laser system, compatible with all Fitzpatrick scale phototypes. METHODS: Forty women undergoing bilateral breast reduction were enrolled in this double-blinded randomized controlled trial. The horizontal sutured incision of one breast was treated with the portable 1210-nm laser while in the operating theatre. The other breast was used as the study control. Objective measurements, subjective clinical assessments and safety evaluation were carried out over 1 year by both clinicians and patients. RESULTS: Six weeks following surgery, better overall appearance and modified OSAS scores were reported for the laser-treated scars when compared to the control group (p = 0.024 and p = 0.079). This supports an early effect of the laser treatment during the inflammatory stage of the healing process. After a post-treatment period of 6 months, there continued to be a strong tendency in favour of the laser treatment based on the subjective scores and corroborated by the objective improvement of the treated scar volume (p = 0.038). At 1 year, the laser-treated scars continued to improve compared to the control ones in terms of volume (p = 0.004), surface (p = 0.017) and roughness (p = 0.002), and these comparatively better results were strengthened with the blind expression of patients' preference for their laser-treated scar (p = 0.025). CONCLUSIONS: This new 1210-nm laser treatment, used as a single session performed immediately after surgery, provides significant objective and subjective improvements in scar appearance. These data can be useful when preparing patients to undergo their surgical procedure. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Clinical evaluation of a dressing with poly absorbent fibres and a silver matrix for managing chronic wounds at risk of infection: a non comparative trial.

OBJECTIVE: To assess the efficacy, safety and acceptability of a new silver poly absorbent dressing (UrgoCleanAg) in the local management of exudative chronic wounds at risk of infection, with inflammatory signs suggesting heavy bacterial load. METHOD: This prospective, multicentre, non-comparative clinical trial was conducted in French hospital wards (dermatology and vascular medicine) or specialised private-practice physicians. Patients were considered at high-risk of infection when presenting with at least three of five selected inflammatory clinical signs, suggesting a heavy bacterial load (pain between two dressing changes, erythema, oedema, malodorous wound and presence of a heavy exudate). They were treated for a maximum period of four weeks, and followed by the physician on a weekly basis, including a clinical examination, area tracings and photographs. The primary efficacy criterion of the trial was the relative wound surface area reduction at the end of the four weeks of treatment. Acceptability was documented by the nursing staff at each dressing change between the weekly evaluations. RESULTS: We recruited 37 patients with chronic wounds. Wound surface area, mostly covered by sloughy tissue, was reduced by 32.5% at the end of the treatment (median value), while the clinical score (maximum value of 5, based on inflammatory clinical signs) decreased from 4.0 to 2.0. Effective debridement properties were documented (62.5% relative reduction of sloughy tissue at week 4; 58.8% of debrided wounds at week 4) and improvement of the periwound skin status was noted (healthy for 28.6% of the patients at week 4 versus 2.7% at baseline). In addition, the tested wound dressing presented a good safety profile associated to a high level of acceptability, noted by both patients and nursing staff. CONCLUSION: These clinical data support that the tested dressing is a credible therapeutic alternative for the management of chronic wounds at risk of infection with inflammatory signs suggesting heavy bacterial load.