Breast reconstruction using TiLOOP Mesh or not
A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh
NA · Tianjin Medical University Cancer Institute and Hospital · NCT05888571
This study is testing if using a special mesh during breast reconstruction helps women feel better and have better results after surgery compared to not using the mesh.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital (other) |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05888571 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the efficacy and safety of immediate prepectoral breast reconstruction in adult women, comparing outcomes when TiLOOP Mesh is utilized versus when it is not. Participants will include those undergoing unilateral or bilateral reconstruction following mastectomy for breast cancer or prophylactic reasons. The study aims to determine if the use of mesh improves surgical outcomes and patient satisfaction. Eligible candidates will be women aged 18-65 with specific criteria regarding their health and surgical needs.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18-65 planning immediate prepectoral breast reconstruction after mastectomy.
Not a fit: Patients with poor perfusion of the breast mastectomy flap or those with a BMI greater than 35 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and recovery for women undergoing breast reconstruction.
How similar studies have performed: While there is ongoing research in breast reconstruction techniques, the specific use of TiLOOP Mesh in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Jian Yin
- Email: yinjian@tjmuch.com
- Phone: +86-22-23340123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prepectoral Breast Reconstruction, TiLOOP Mesh