Effectiveness Study of MIST Therapy After Cosmetic Surgery Procedures of the Face and Body
|Cosmetic Surgery||Device: MIST Therapy Other: Standard Postoperative Incision Care||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Use of MIST Ultrasound Therapy to Minimize Edema, Bruising and Scarring After Cosmetic Surgery Procedures of the Face and Body|
- Reduction in swelling, bruising, firmness and pain [ Time Frame: 2-6 weeks ]
Outcomes measured by
- Subject-completed pain and swelling assessments
- Observer-completed bruising, swelling and firmness assessments
- Reduction in wound healing complications [ Time Frame: 12 weeks ]Outcome measured by wound evaluations assessing wound dehiscences, suture spitting, and localized wound infections.
- Improvements in scarring [ Time Frame: 12 weeks ]Outcome measured by Subject-completed and Observer-completed scar assessment scales.
- Patient satisfaction [ Time Frame: 12 weeks ]Outcome measure: Subject-completed questionnaire
|Study Start Date:||October 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Active Comparator: SOC Treated Side of Incision
One side of the incision will be treated with surgeon's standard postoperative care including cleansing, creams, dressings
Other: Standard Postoperative Incision Care
Incision cleansing, topical creams, and dressing as needed
Active Comparator: MIST Treated Side of Incision
One half of the incision will receive MIST Therapy treatments 3 times per week for 2 weeks
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.
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206855
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Robert D Galiano, MD||Northwestern University Feinberg School of Medicine|