RecruitingNot Applicable

Pre-pectoral Breast Reconstruction With or Without Mesh

China164 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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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;

What they're measuring

Major Complication Rates

Timeframe: up to 12 months after surgery

Patient Breast-Q questionnaire

Timeframe: up to 12 months after surgery

Trial details

NCT IDNCT05888571

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Jian Yin

+86-22-23340123 yinjian@tjmuch.com

View on ClinicalTrials.gov More Prepectoral Breast Reconstruction trials