NCT02562170

Brief Summary

Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 breast-cancer

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4 breast-cancer

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, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

September 18, 2015

Last Update Submit

September 26, 2015

Conditions

Breast CancerHereditary Breast and Ovarian Cancer Syndrome

Keywords

breastreconstructionmeshacellular dermal matrix

Outcome Measures

Primary Outcomes (6)

  • complications

    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss

    up to two weeks after surgery

  • change of baseline patient quality of life after 3 and 6 months

    questionnaire

    up to two weeks after surgery (=baseline), 3 and 6 months after surgery

  • change of baseline cosmetic outcome after 3 and 6 months

    four point Harris Scale (1=poor, 4=excellent)

    up to two weeks after surgery (=baseline), 3 and 6 months after surgery

  • change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months

    The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound

    up to two weeks after surgery (=baseline), 3 and 6 months after surgery

  • complications

    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss

    3 months after surgery

  • complications

    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss

    6 months after surgery

Study Arms (2)

TiLoop Bra

ACTIVE COMPARATOR

immediate breast reconstruction with an implant and TiLoop Bra

Device: TiLoop Bra

Protexa

ACTIVE COMPARATOR

immediate breast reconstruction with an implant and Protexa

Device: Protexa

Interventions

TiLoop BraDEVICE
TiLoop Bra
ProtexaDEVICE
Protexa

Eligibility Criteria

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

You may qualify if:

  • breast cancer patients with indication for skin or nipple sparing mastectomy
  • BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy

You may not qualify if:

  • prior local radiotherapy
  • inflammatory breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Gschwantler-Kaulich D, Schrenk P, Bjelic-Radisic V, Unterrieder K, Leser C, Fink-Retter A, Salama M, Singer C. Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial. Eur J Surg Oncol. 2016 May;42(5):665-71. doi: 10.1016/j.ejso.2016.02.007. Epub 2016 Feb 23.

    PMID: 26947961DERIVED

MeSH Terms

Conditions

Breast NeoplasmsHereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplastic Syndromes, HereditaryOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Daphne Gschwantler-Kaulich, Ass.Prof.Dr.

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.Dr.

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 29, 2015

Study Start

July 1, 2013

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

AU(1)