NCT01206855

Effectiveness Study of MIST Therapy After Cosmetic Surgery Procedures of the Face and Body

Use of MIST Ultrasound Therapy to Minimize Edema, Bruising and Scarring After Cosmetic Surgery Procedures of the Face and Body

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,440 (actual)
• Sponsor: Celleration, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Cosmetic Surgery

Interventions

Type	Name	Description
DEVICE	MIST Therapy	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.
OTHER	Standard Postoperative Incision Care	Incision cleansing, topical creams, and dressing as needed

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-08-01
• Completion: 2013-12-01
• First posted: 2010-09-22
• Last updated: 2014-10-08

Locations

1 site across 1 country: United States