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OpenTrials
Completed

NCT Number: NCT02562170

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

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hereditary Breast and Ovarian Cancer Syndrome Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TiLoop Bra

Device

Protexa

Device

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2015
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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