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

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.

Study Overview

• Status: Completed
• Conditions: Cosmetic Surgery
• Intervention / Treatment: Device: MIST Therapy; Other: Standard Postoperative Incision Care

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)

• Study Type: Interventional
• Enrollment (Actual): 3440
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must be between 18-75 years of age
• Subject must be compliant with the study visits
• Subject must be in good health
• Subject must be able to provide written informed consent

• Subject must be undergoing one or more of the following bilateral procedures:

  • Rhytidectomies
  • Blepharoplasty
  • Breast augmentation
  • Mastopexy
  • Breast reduction
  • Abdominoplasty

Exclusion Criteria:

• Subject has any medical condition that would result in poor wound healing
• Subject has any medical condition that would result in poor scarring
• Subject is taking medications that may affect healing or scarring, including Arnica
• Subject has diabetes
• Area to be treated has been irradiated
• Subject is undergoing a secondary procedure that may be associated with prior scar tissue in the area undergoing surgery
• Subject has any medical condition that in the opinion of the Investigator would make the subject an inappropriate candidate for this study, including a higher than usual concern for surgical complications
• Subject has electronic implants or prosthesis
• Subject has cardiac pacemaker
• Pregnant woman
• Skin cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: MIST device; MIST ultrasound treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in swelling, bruising, firmness and pain	Outcomes measured by; Subject-completed pain and swelling assessments; Observer-completed bruising, swelling and firmness assessments	2-6 weeks
Reduction in wound healing complications	Outcome measured by wound evaluations assessing wound dehiscences, suture spitting, and localized wound infections.	12 weeks
Improvements in scarring	Outcome measured by Subject-completed and Observer-completed scar assessment scales.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Outcome measure: Subject-completed questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Celleration, Inc.
• Investigators: Principal Investigator: Robert D Galiano, MD, Northwestern University Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 21, 2010
• First Submitted That Met QC Criteria: September 21, 2010
• First Posted (Estimate): September 22, 2010

Study Record Updates

• Last Update Posted (Estimate): October 8, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: MIST Therapy
• Other Study ID Numbers: Celleration-NU-01