Resumen

El propósito de este estudio es comparar los cambios estructurales en la piel producidos por el dispositivo CO2RE versus el RePair.

Descripción detallada

El CO2RE es un sistema de CO2 fraccionado que permite el tratamiento preciso, eficaz y simultáneo de la superficie de la piel, los niveles dérmicos medio y profundo, realizando además de manera fluida el resurfacing tradicional con CO2 y la escisión láser de lesiones con control de precisión sobre la intensidad, el patrón y la profundidad de ablación. El RePair es un sistema de láser de CO2 fraccionado de 10.600 nm que trata la piel envejecida y dañada por el sol mediante columnas microscópicas de láser que penetran en profundidad en la piel para acelerar la remodelación del colágeno por parte del organismo.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 60 YearsSexo: ALL

Criterios de inclusión

Subject is scheduled and cleared for an abdominoplasty procedure by a referring plastic surgeon.
Subject has read and signed the informed consent form.
Subject is willing to follow the treatment and follow up schedule and undertake to carry out all necessary precautions and instructions.
Female candidates must be post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Subject is willing to have photographs taken which will be used for educational and marketing presentations and/or publications.

Criterios de exclusión

Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. To verify that subjects who are enrolled are not pregnant, a urine pregnancy test will be performed for each women subject at baseline and again at the end of the study.
Subject has any active electrical implant anywhere in the body, such as a pacemaker, an insulin pump or an internal defibrillator.
Subject has a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
Subject is or has undergone any form of treatment for active cancer in the treated area, suffering or having a history of skin cancer or any other cancer in the treated area, including presence of malignant or pre-malignant pigmented lesions in the treated area.
Subject suffers from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders, hepatitis and fat metabolism disorders.
Subject suffers from abdominal wall hernia and is a candidate for treatment in the abdomen.
Subject has undergone Bariatric surgery with significant skin laxity.
Subject has a history of advanced fatty liver or a known liver dysfunction.
Subject has a thromboembolic phenomenon, hypercoagulability, and tendency to bleed or bruise or is taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician's discretion).
Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection) or currently using immunosuppressive medications.
Subject has a history of significant lymphatic drainage problems.
Subject is suffering from hormonal imbalance which may affect weight, as per the Investigator's discretion.
Subject is suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
Subject has a history of epidermal or dermal disorders (particularly if involving collagen or microvascularity), keloid scarring or of abnormal wound healing.
Subject received treatment with laser or other devices in the treated areas within 6 months of treatment.
Subject underwent a liposuction surgery or any contouring treatment in the areas intended for treatment within 9 months of treatment.
Subject is recently tanned in areas to be treated.
Subject is participating in a study of another device or drug within 1 month prior to enrollment or during this study.
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Intervenciones

device

CO2RE

Subjects will be randomly assigned to three different time-points of laser treatment: immediately, 1 week or 4 weeks prior the scheduled abdominoplasty. Subjects will be required to attend between 2 to 3 visits depending on the interval between the treatment and the abdominoplasty procedure. One side of the abdomen will be treated using the CO2RE device and the other side with the RePair device. The investigator will also leave an untreated area (control). Punch biopsies will be obtained before or during the abdominoplasty procedure from the two treated areas (CO2RE and RePair) and one control (un-treated) areas (on the abdominoplasty area) for histological evaluation.

device

Evaluación Histológica In Vivo del Dispositivo CO2RE Versus el Dispositivo RePair en Pacientes Preabdominoplastia

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

CO2RE

Repair

Ubicaciones

Advance Laser Therapy/Vanguardia en Terapia Laser

Patrocinadores