Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
Recruiting
NCT Number: NCT05888571
Pre-pectoral Breast Reconstruction With or Without Mesh
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
- SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
- Tissue expander size =<800cc, implant size =<600cc;
- The blood perfusion of breast skin flap was well;
- Do not smoking in the last 4 weeks or more
- Patients with normal expectations and mental health for breast reconstruction;
- Signed consent to participate
Exclusion criteria
- Poor perfusion of breast mastectomy flap;
- II stage breast reconstruction patients;
- History of chest radiotherapy;
- BMI greater than 35;
- Patients who have not quit smoking within the last 4 weeks;
Treatment and study plan
prepectoral breast reconstruction
ProcedurePatients receive immediate prepectoral breast reconstruction
Tiloop Mesh implantation
ProcedurePatients receive immediate prepectoral breast reconstruction with Tiloop Mesh
Primary outcomes
-
Major Complication Rates
Time frame: up to 12 months after surgery
The rate of major complications in the two groups
-
Patient Breast-Q questionnaire
Time frame: up to 12 months after surgery
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Secondary outcomes
-
Minor Complication Rates
Time frame: up to 12 months after surgery
The rate of minor complications in the two groups
-
Rates of capsule contracture
Time frame: up to 24 months after surgery
The rates of capsule contracture in the two groups
-
The rate of surgical revision of reconstructed breasts
Time frame: up to 12 months after surgery
To record the rate of surgical revision events of the reconstructed breasts
-
The rate of implant or tissue expander removal
Time frame: up to 12 months after surgery
The rate of implant or tissue expander removal in the two groups
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Other
Registry information
Official study title
A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jun 5, 2023
- Registry last updated
- Jan 31, 2024
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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