Effectiveness Study of MIST Therapy After Cosmetic Surgery Procedures of the Face and Body
Condition: Cosmetic Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      A clinical trial to evaluate the effect of MIST Therapy on outcomes after cosmetic
      procedures(including facelifts, blepharoplasties, breast augmentations and reductions,
      mastopexies, and abdominoplasties) traditionally associated with pain, swelling, bruising,
      and scarring. The study will test the hypothesis that MIST Therapy can decrease the incidence
      and severity of these surgical sequelae throughout the acute and sub-acute phases of healing.
    

Detailed description: 
      A post-market, single-center, prospective, randomized, single-blinded study.

      Each subject serves as her/his own control. The procedures chosen are bilateral, and each
      subject will have one side of the surgical site treated with MIST Therapy and the other side
      left untreated except for the surgeon's usual postoperative care protocol.

      Study objectives: Comparison between MIST-treated side versus the contralateral untreated
      side on the reduction in swelling, bruising, firmness, pain, and wound healing complications;
      the potential improvements in scarring; and the improvements in patient satisfaction.

      Subject recruitment: A total of 30 subjects will be enrolled into the study. The MIST-treated
      side will be randomly assigned. The assigned MIST-treated side will be known to the subject
      and assistant providing MIST Therapy, but will not be known to the Investigator/assessor.

      Protocol and procedures: Subjects will be followed until 12 weeks post-surgery. The side
      assigned for MIST Therapy treatment will be treated weekly, beginning 2-3 days post-surgery,
      and continuing until 3 weeks post-surgery. A baseline evaluation will include demographic
      data, medical and surgical history, smoking history, laboratory tests, and digital
      photography of each side of the wound.

      Subjects will be assessed at the following timepoints post-surgery: Days 2,7,14, 21, 28, 42
      and 84.

      The following procedures and assessments will be obtained at specific timepoints:

        -  MIST Therapy treatments to the assigned wound side (Days 2, 7, 14, 21)

        -  Digital photographs (Baseline, Days 14, 21, 42, 84)

        -  Bruising assessment (Days 7 and 14)

        -  Pain assessment (Days 7 and 14)

        -  Swelling assessment (Days 7 and 14)

        -  Firmness assessment (Days 21 and 42)

        -  Scar assessment (Days 21 and 84)

        -  Subject satisfaction (Day 84)

        -  Concomitant treatments including use of moisturizers, scar creams and compression
           garments(all timepoints)

        -  Wound healing complication assessment (all timepoints)

        -  Adverse event assessment (all timepoints following informed consent)
    

Intervention name(s): MIST Therapy; Standard Postoperative Incision Care
Intervention type(s): Device; Other
Intervention description(s): Low-frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed without direct contact of the device with the body.; Incision cleansing, topical creams, and dressing as needed
Other intervention name(s): MIST device; MIST ultrasound treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MIST Therapy