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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celleration, Inc.
ClinicalTrials.gov Identifier:
NCT01206855
First received: September 21, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Cosmetic Surgery
 Device: MIST Therapy
Other: Standard Postoperative Incision Care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Celleration, Inc.:

Primary Outcome Measures:
  • Reduction in swelling, bruising, firmness and pain [ Time Frame: 2-6 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    Outcome measured by wound evaluations assessing wound dehiscences, suture spitting, and localized wound infections.

  • Improvements in scarring [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Outcome measured by Subject-completed and Observer-completed scar assessment scales.


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Outcome measure: Subject-completed questionnaire


Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206855

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Celleration, Inc.
Investigators
Principal Investigator: Robert D Galiano, MD Northwestern University Feinberg School of Medicine
  More Information

No publications provided

Responsible Party: Celleration, Inc.
ClinicalTrials.gov Identifier: NCT01206855     History of Changes
Other Study ID Numbers: Celleration-NU-01
Study First Received: September 21, 2010
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Celleration, Inc.:
MIST Therapy

ClinicalTrials.gov processed this record on May 23, 2013