D Casanova1, A Alliez1, C Baptista1, D Gonelli1, Z Lemdjadi2, S Bohbot3. 1. Plastic and Reconstructive Surgery, University Hospital La Conception, APHM, 264, Rue Saint-Pierre, 13385, Marseille, France. 2. Laboratoires Urgo, 42 Rue de Longvic, BP 157, 21304, Chenôve, France. 3. Laboratoires Urgo, 42 Rue de Longvic, BP 157, 21304, Chenôve, France. s.bohbot@fr.urgo.com.
Abstract
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 .
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 .