Scar Prevention Using Fractional Carbon Dioxide Laser Treatment
Lumenis UltraPulse single fractional CO2 laser treatment thin skin
+ Single fractional CO2 treatment at surgical area closure procedure on thick skin
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2013
Date à laquelle le premier participant a commencé l'étude.In this study the investigators intend to determine the impact of fractional CO2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax, etc.) and on thick skin (abdominoplasty procedure) on scar formation. The investigators will also evaluate the effect of shallow fractional laser treatment versus deep parameters settings. If effective treatments could be performed at time of surgery, this would result in both time and cost saving to the patient and to the healthcare system and will improve patient's self-image post surgeries.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.10 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Inclusion Criteria: Male or Females At least 18 and no more than 65 years old The surgical area closure in these subjects should be at least 4cm Type of surgery scheduled: Site 1: Surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin (abdominoplasty procedure) Willing to comply with study dosing and complete the entire course of the study Exclusion Criteria: Active bacterial, fungal, or viral infection in the treatment area Active cold sores, or herpes in the treatment area Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study History of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes. History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis) Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics) History or presenting with a keloid scar Any current or recent treatment for cancer, unless the surgical procedure of issue is for cancer treatment purposes. Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator Female subject who is pregnant, nursing an infant or is less than 6 months after termination of breast feeding Small surgical closure (<4cm)
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site