NCT01206855

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,440

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

September 21, 2010

Last Update Submit

October 6, 2014

Conditions

Cosmetic Surgery

Keywords

MIST Therapy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Patient satisfaction

    12 weeks

Study Arms (2)

SOC Treated Side of Incision

ACTIVE COMPARATOR

One side of the incision will be treated with surgeon's standard postoperative care including cleansing, creams, dressings

Other: Standard Postoperative Incision Care

MIST Treated Side of Incision

ACTIVE COMPARATOR

One half of the incision will receive MIST Therapy treatments 3 times per week for 2 weeks

Device: MIST Therapy

Interventions

MIST TherapyDEVICE

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.

Also known as: MIST device, MIST ultrasound treatment
MIST Treated Side of Incision
Standard Postoperative Incision CareOTHER

Incision cleansing, topical creams, and dressing as needed

SOC Treated Side of Incision

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Robert D Galiano, MD

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations

US(1)