NCT02201979

Brief Summary

Breast lift surgery performed in combination with breast implants is a common cosmetic operation. However, there have been concerns regarding the safety of this treatment combination. Some investigators are concerned that an implant may increase the risk of complications, including loss of circulation to the nipple and areola. This study was undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent imaging and to determine whether a breast implant compromises blood supply to the nipple and areola.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

July 24, 2014

Last Update Submit

November 18, 2014

Conditions

Breast SaggingPtosisLoss of Breast Volume

Keywords

breastptosissaggingimplantlift

Outcome Measures

Primary Outcomes (1)

  • Blood supply to breast as evaluated by laser fluorescent imaging

    Laser fluorescent imaging is used to evaluate breast blood supply.

    5 months

Study Arms (1)

Breast lift in combination with implants.

Patients undergoing breast lifts in combination with implants are studied using laser fluorescent imaging to evaluate blood supply.

Procedure: Vertical breast lift with implants

Interventions

Vertical breast lift with implantsPROCEDURE
Breast lift in combination with implants.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult women undergoing cosmetic breast lifts in combination with implants.

You may qualify if:

  • Women aged 18 - 80
  • Consent for participation

You may not qualify if:

  • history of allergy to iodinated contrast dye -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swanson Center

Leawood, Kansas, 66211, United States

Location

Related Publications (1)

  • Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013 Jul;132(1):30e-45e. doi: 10.1097/PRS.0b013e3182910b2e.

    PMID: 23806952BACKGROUND

MeSH Terms

Conditions

Blepharoptosis

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Eric Swanson, M.D.

    Swanson Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 28, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

US(1)