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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT02562170
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Jul 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. complications [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 [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 [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 [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 [3 months after surgery]

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

6. complications [6 months after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Principal Investigator: Daphne Gschwantler-Kaulich, Ass.Prof.Dr., Medical University Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daphne Gschwantler-Kaulich, Ass.Prof.Dr., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT02562170
• Other Study ID Numbers: 1401/2013
• First Posted: Sep 29, 2015
• Last Update Posted: Sep 29, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Daphne Gschwantler-Kaulich, Ass.Prof.Dr., Medical University of Vienna: breast; reconstruction; mesh; acellular dermal matrix
• Additional relevant MeSH terms: Hereditary Breast and Ovarian Cancer Syndrome

Study Results

No Results Posted as of Sep 29, 2015