Breast reconstruction using TiLOOP Mesh or not

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.