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Clinical trial of acellular allogeneic dermis for prosthesis wrapping and soft tissue repair in breast reconstruction

Clinical trial of acellular allogeneic dermis for prosthesis wrapping and soft tissue repair in breast reconstruction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051938
Enrollment
Unknown
Registered
2021-10-09
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

None

Interventions

Experimental group:Test product
Control group:Control product

Sponsors

Tianjin Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Plan to undergo a skin-sparing mastectomy and undergo breast implant reconstruction; 2.Aged 18 to 70 years, female; 3.The breast volume is moderate, and the size of the prosthesis (cup) should be less than 400cc for preoperative measurement; 4.No breast sagging, moderate to mild sagging or pseudo-sagging; 5.Patients who agree to sign the informed consent form and can follow the doctor's orders and have regular follow-up visits.

Exclusion criteria

Exclusion criteria: 1.Bilateral breast tumors; 2.Inverted nipples, discharge, eczema-like changes, and orange peel-like changes in breast skin caused by tumors; 3.Tumor and pectoralis major muscle adhesion; 4.Patients who received neoadjuvant therapy before surgery; 5.Body mass index greater than 30kg/m^2; 6.Smoking and alcohol dependence; 7.Pregnant or lactating women; 8.History of autoimmune diseases; 9.History of mental and psychological illness; 10.Local or systemic infection that may affect surgery.

Design outcomes

Primary

MeasureTime frame
Able to successfully implant the patch in accordance with the established surgical plan;The patch was not taken out after 24 weeks;

Countries

China

Contacts

Public ContactZhang Haiying

Beijing Jayyalife Biological Technology Co., Ltd

835720957@qq.com+86 13691212175

Outcome results

None listed

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