Non-Puerperal Mastitis
Conditions
Interventions
Treatment Group:Kangfuxin Solution Irrigation
Control Group:Normal Saline Irrigation
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Female patients aged 18 to 75 years (inclusive); 2) A confirmed diagnosis of PCM or GLM based on pathology and clinical symptoms; 3) Being in the ulcerated stage of the disease, i.e., presenting with an unhealed skin breach following spontaneous rupture or surgical incision and drainage.; 4) Consent to undergo the sinus tract irrigation procedure and providing written informed consent; 5) Willingness to be randomly assigned to a treatment group and to participate in the intervention and follow-up.
Exclusion criteria
Exclusion criteria: 1) Pathological findings indicating tuberculosis or malignant tumor cells; 2) Pregnant or breastfeeding patients; 3) Patients concurrently participating in other clinical trials; 4) Patients with severe cardiac, hepatic, or renal dysfunction, or those with uncontrolled hypertension or diabetes; 5) Patients with poor compliance or those unable to complete the study interventions and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory Mass Size;Visual Analog Scale (VAS) Pain Scores;Duration of Intervention;Recurrence Rate; | — |
Countries
China
Contacts
Public ContactXiufei Gao
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed