NCT02985073

Brief Summary

This study compares the outcome using a biological mesh (Veritas®) compared to a non biological mesh (TIGR®) in immediate breast reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable 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

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

3.2 years

First QC Date

November 30, 2016

Last Update Submit

October 13, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Total complication rate

    Total complication rate within one year from surgery

    12 months

Secondary Outcomes (4)

  • Total infection rate

    30 days

  • Total implant loss rate

    12 months

  • Aesthetic outcome

    12 months

  • HQOL

    12 months

Other Outcomes (1)

  • Cost evaluation

    12 months

Study Arms (2)

Veritas® mesh

EXPERIMENTAL

Use of Veritas mesh in conjunction with immediate breast reconstruction on one side

Device: Veritas®

TIGR® mesh

EXPERIMENTAL

Use of TIGR® mesh in conjunction with immediate breast reconstruction on one side

Device: TIGR®

Interventions

Veritas®DEVICE

Biologic mesh

Veritas® mesh
TIGR®DEVICE

Non biologic mesh

TIGR® mesh

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a confirmed breast cancer gene mutation or a calculated increased risk \> 20% of developing a breast cancer during her lifetime.

You may not qualify if:

  • All patients that don't fulfill criteria above
  • Previous breast surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept . of plastic surgery

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Related Publications (4)

  • Hansson E, Burian P, Hallberg H. Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020 Jun;54(3):131-136. doi: 10.1080/2000656X.2019.1704766. Epub 2019 Dec 20.

    PMID: 31859575RESULT

  • Hansson E, Edvinsson AC, Hallberg H. Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study. Breast J. 2020 Sep;26(9):1756-1759. doi: 10.1111/tbj.13921. Epub 2020 Jun 9.

    PMID: 32515840RESULT

  • Hansson E, Edvinsson AC, Elander A, Kolby L, Hallberg H. First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study. J Surg Oncol. 2021 Jan;123(1):80-88. doi: 10.1002/jso.26227. Epub 2020 Oct 13.

    PMID: 33051871RESULT

  • Paganini A, Meyer S, Hallberg H, Hansson E. Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4133-4143. doi: 10.1016/j.bjps.2022.08.013. Epub 2022 Aug 23.

    PMID: 36154981RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lars Kölby

    Dept of plastic surgery Sahlgrenska University Hospital Gothenburg Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 7, 2016

Study Start

November 1, 2016

Primary Completion

January 1, 2020

Study Completion

September 1, 2022

Last Updated

October 17, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)