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Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study

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ClinicalTrials.gov Identifier: NCT02562170
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Daphne Gschwantler-Kaulich, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Hereditary Breast and Ovarian Cancer Syndrome Device: TiLoop Bra Device: Protexa Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
Study Start Date : July 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Active Comparator: TiLoop Bra
immediate breast reconstruction with an implant and TiLoop Bra
Device: TiLoop Bra
Active Comparator: Protexa
immediate breast reconstruction with an implant and Protexa
Device: Protexa



Primary Outcome Measures :
  1. complications [ Time Frame: up to two weeks after surgery ]
    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss

  2. change of baseline patient quality of life after 3 and 6 months [ Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery ]
    questionnaire

  3. change of baseline cosmetic outcome after 3 and 6 months [ Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery ]
    four point Harris Scale (1=poor, 4=excellent)

  4. change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months [ Time Frame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery ]
    The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound

  5. complications [ Time Frame: 3 months after surgery ]
    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss

  6. complications [ Time Frame: 6 months after surgery ]
    hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • prior local radiotherapy
  • inflammatory breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562170


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Daphne Gschwantler-Kaulich, Ass.Prof.Dr. Medical University Vienna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daphne Gschwantler-Kaulich, Ass.Prof.Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02562170     History of Changes
Other Study ID Numbers: 1401/2013
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by Daphne Gschwantler-Kaulich, Medical University of Vienna:
breast
reconstruction
mesh
acellular dermal matrix
Additional relevant MeSH terms:
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Hereditary Breast and Ovarian Cancer Syndrome
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases