Pre-pectoral Breast Reconstruction With or Without Mesh

• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05888571
• Collaborator: (none)
• Enrollment: 164
• Arms: 2
• Anticipated Duration (Months): 41

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prepectoral Breast Reconstruction; TiLOOP Mesh	Procedure: prepectoral breast reconstruction; Procedure: Tiloop Mesh implantation	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2026
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: prepectoral breast reconstruction with Mesh Immediate prepectoral breast reconstruction with Mesh	Procedure: prepectoral breast reconstruction; Patients receive immediate prepectoral breast reconstruction; Procedure: Tiloop Mesh implantation; Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh
Experimental: prepectoral breast reconstruction without Mesh Immediate prepectoral breast reconstruction without Mesh	Procedure: prepectoral breast reconstruction; Patients receive immediate prepectoral breast reconstruction

Outcome Measures

Primary Outcome Measures

1. Major Complication Rates [up to 12 months after surgery]

   The rate of major complications in the two groups

2. Patient Breast-Q questionnaire [up to 12 months after surgery]

   We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.

Secondary Outcome Measures

1. Minor Complication Rates [up to 12 months after surgery]

   The rate of minor complications in the two groups

2. Rates of capsule contracture [up to 24 months after surgery]

   The rates of capsule contracture in the two groups

3. The rate of surgical revision of reconstructed breasts [up to 12 months after surgery]

   To record the rate of surgical revision events of the reconstructed breasts

4. The rate of implant or tissue expander removal [up to 12 months after surgery]

   The rate of implant or tissue expander removal in the two groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tianjin Medical University Cancer Institute and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tianjin Medical University Cancer Institute and Hospital
• ClinicalTrials.gov Identifier: NCT05888571
• Other Study ID Numbers: E20230013
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 12, 2023