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A randomized controlled study to evaluate the efficacy and safety of breast patch for soft tissue reinforcement in Reduction Mammoplasty

A randomized controlled study to evaluate the efficacy and safety of breast patch for soft tissue reinforcement in Reduction Mammoplasty

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116445
Enrollment
Unknown
Registered
2026-01-09
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction Mammoplasty

Interventions

Test group:Reduction mammoplasty with concomitant use of breast patch
Control group:Reduction mammoplasty

Sponsors

Fudan University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 or older; 2. Patients with unilateral breast cancer who are scheduled to undergo therapeutic reduction mammoplasty on the affected side and contralateral (healthy-side) reduction mammoplasty for symmetry; 3. No smoking history or having quit smoking for more than 4 weeks (inclusive); 4. Willing to participate voluntarily after receiving adequate informed consent and having signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Patients who have received prior radiotherapy; 2. Patients with uncontrolled diabetes mellitus, severe cardiovascular disease, cardiac insufficiency, or significant hepatic, renal, or hematologic disorders, or other serious systemic diseases; 3. Patients with psychiatric disorders or active psychiatric symptoms; 4. Patients who are pregnant, breastfeeding, or planning to conceive during the study period; 5. Patients currently participating in another clinical trial that may interfere with this study; 6. Patients with poor compliance who are unable or unlikely to adhere to the required study procedures, assessments, or follow-up visits; 7. Patients whom the investigator deems otherwise unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Changes in breast ptosis;

Secondary

MeasureTime frame
Changes in Breast-Q (Reduction Mammoplasty Module) scores;Assessment of aesthetic outcomes of the breast;

Countries

China

Contacts

Public ContactWu Jiong

Fudan University Cancer Hospital

wujiong1122@vip.sina.com+86 136 0163 7369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026