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Randomized Controlled Study on Modified Nipple Correction Surgery with Incision & Debridement Surgery for Non-Puerperal Mastitis with Inverted Nipples

Randomized Controlled Study on Modified Nipple Correction Surgery with Incision & Debridement Surgery for Non-Puerperal Mastitis with Inverted Nipples

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129158
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

PCM is consisted of non-puerperal mastitis (NPM)

Interventions

control group:Traditional Gu's Nipple Correction Surgery with Incision & Debridement Surgery
treatment group:Modified Nipple Correction Surgery with Incision & Debridement Surgery

Sponsors

LONGHUA Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-60, female; 2. Meets the diagnostic criteria for non-lactational mastitis; 3. The affected breast has a primary nipple inversion; 4. The lesion area is suitable for a breast-conserving incision and expansion surgery; 5. The patient has been informed about this study and voluntarily chooses surgical treatment; 6. Willing to participate in this clinical trial observation and can cooperate with regular follow-ups.

Exclusion criteria

Exclusion criteria: 1.Women who are pregnant, breastfeeding or have the intention to become pregnant in the near future; 2.Secondary nipple inversion (such as caused by trauma, surgery, or tumor adhesion); 3.Those with primary or secondary malignant tumors of the breast on the affected side; 4.Those who have undergone nipple orthopedic surgery on the affected side of the nipple in the past; 5.Suffering from severe heart, liver, kidney, coagulation dysfunction or immune system diseases; 6.Those who are alcoholics or drug addicts, have severe mental disorders or communication problems; 7.Patients who have recently participated in or are currently participating in other clinical trials; 8.For any reason, those who cannot cooperate with the research will not be allowed to follow up on schedule.

Design outcomes

Primary

MeasureTime frame
Effect of nipple correction;Recurrence rate of Non-Puerperal Mastitis;

Secondary

MeasureTime frame
blood loss;failure of the nipple correction;Suture cutting reaction;the level of pain for the incision;the satisfaction of patients;pain level of the breast;time of surgery;the function of nipple;Complications related to orthotics;Systemic or serious adverse events;Breast abscess formation;Perioperative complications;

Countries

China

Contacts

Public ContactYe Meina

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

yemeina2002@126.com+86 21 6438 5700

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026