Pre-pectoral Breast Reconstruction With or Without Mesh

NCT ID: NCT05888571

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-12-31

Brief Summary

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To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.

Detailed Description

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The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.

Conditions

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Prepectoral Breast Reconstruction TiLOOP Mesh

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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prepectoral breast reconstruction with Mesh

Immediate prepectoral breast reconstruction with Mesh

Group Type ACTIVE_COMPARATOR

prepectoral breast reconstruction

Intervention Type PROCEDURE

Patients receive immediate prepectoral breast reconstruction

Tiloop Mesh implantation

Intervention Type PROCEDURE

Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh

prepectoral breast reconstruction without Mesh

Immediate prepectoral breast reconstruction without Mesh

Group Type EXPERIMENTAL

prepectoral breast reconstruction

Intervention Type PROCEDURE

Patients receive immediate prepectoral breast reconstruction

Interventions

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prepectoral breast reconstruction

Patients receive immediate prepectoral breast reconstruction

Intervention Type PROCEDURE

Tiloop Mesh implantation

Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
2. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
3. Tissue expander size =\<800cc, implant size =\<600cc;
4. The blood perfusion of breast skin flap was well;
5. Do not smoking in the last 4 weeks or more
6. Patients with normal expectations and mental health for breast reconstruction;
7. Signed consent to participate

Exclusion Criteria

1. Poor perfusion of breast mastectomy flap;
2. II stage breast reconstruction patients;
3. History of chest radiotherapy;
4. BMI greater than 35;
5. Patients who have not quit smoking within the last 4 weeks;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Yin

Role: CONTACT

+86-22-23340123 ext. 1171

Chunyong Han

Role: CONTACT

+86-22-23340123 ext. 1171

Facility Contacts

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Chunyong Han, MD.

Role: primary

+86-22-23340123 ext. 1174

Other Identifiers

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E20230013

Identifier Type: -

Identifier Source: org_study_id

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