Cosmetic SurgeryPhase 4NCT01206855
Effectiveness Study of MIST Therapy After Cosmetic Surgery Procedures of the Face and Body
A Phase 4 study testing MIST Therapy and Standard Postoperative Incision Care in people with Cosmetic Surgery, run by Celleration, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cosmetic Surgery
- What is being tested?
- MIST Therapy and Standard Postoperative Incision Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,440 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Blepharoplasty
- Breast augmentation
- Mastopexy
- Breast reduction
- Abdominoplasty
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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
- Being tested
- MIST Therapy, Standard Postoperative Incision Care
- Keywords
- MIST Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIST TherapyDevice
Also called MIST device, MIST ultrasound treatment
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.
Standard Postoperative Incision CareOther
Incision cleansing, topical creams, and dressing as needed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: MIST Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in swelling, bruising, firmness and pain
Outcomes measured by
- Subject-completed pain and swelling assessments
- Observer-completed bruising, swelling and firmness assessments
Measured: 2-6 weeks
Reduction in wound healing complications
Outcome measured by wound evaluations assessing wound dehiscences, suture spitting, and localized wound infections.
Measured: 12 weeks
Improvements in scarring
Outcome measured by Subject-completed and Observer-completed scar assessment scales.
Measured: 12 weeks
Secondary outcomes (1)
Patient satisfaction
Outcome measure: Subject-completed questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celleration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert D Galiano, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206855
- Sponsor's protocol ID
- Celleration-NU-01
- Status last verified
- Oct 2014
- First submitted
- 21 Sep 2010
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of MIST Ultrasound Therapy to Minimize Edema, Bruising and Scarring After Cosmetic Surgery Procedures of the Face and Body
- ClinicalTrials.gov ID
- NCT01206855
- Acronym / sponsor ID
- Celleration-NU-01
- Conditions
- Cosmetic Surgery
- Keywords
- MIST Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,440 participants (actual)
- Lead sponsor
- Celleration, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC Treated Side of Incision | Active comparator | Other: Standard Postoperative Incision CareOne side of the incision will be treated with surgeon's standard postoperative care including cleansing, creams, dressings |
| MIST Treated Side of Incision | Active comparator | Device: MIST TherapyOne half of the incision will receive MIST Therapy treatments 3 times per week for 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIST TherapyAlso: MIST device, MIST ultrasound treatmentLow-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. | Device | MIST Treated Side of Incision |
| Standard Postoperative Incision CareIncision cleansing, topical creams, and dressing as needed | Other | SOC Treated Side of Incision |
Primary outcome
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.
1 secondary outcome
Patient satisfaction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Galiano, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MIST Therapy and Standard Postoperative Incision Care in people with Cosmetic Surgery, run by Celleration, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in swelling, bruising, firmness and pain (time frame: 2-6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.