Mastitis resulting in immature scar.
Conditions
Interventions
Experimental Group:Ten-Flavor Golden Yellow Ointment is used externally for the treatment of breast inflammation complicated with immature scars. Ten-Flavor Golden Yellow Ointment (provided by the Pha
Control Group:Apply externally (Shanghai Modern Pharmaceutical Co., Ltd., National Drug Approval No. Z31020564), provided uniformly by the hospital pharmacy. Take a layer of ointment approximately 1mm
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with mastitis before enrollment and clinically cured at enrollment. Scars must be formed by spontaneous rupture of previous breast abscesses and must be immature scars (=12 months after epithelialization of the wound surface). 2. Scar characteristics must meet: area 0.25–225 cm² (25 mm²–225 cm²), thickness 0.5–20 mm, Vancouver Scar Scale score 4–12 points. 3. Participants must be female, aged 18–45 years. 4. No systemic or local treatment for scars within 1 month before enrollment, including but not limited to glucocorticoids, immunosuppressants/biologics, 5-fluorouracil, silicone gel/silicone sheets, pressure therapy, laser/cryotherapy/radiotherapy, surgery, acupuncture, etc. 5. Voluntarily participate and sign a written informed consent form, able to complete follow-up as planned, and provide complete clinical data.
Exclusion criteria
Exclusion criteria: 1. The scar is not caused by spontaneous rupture of a breast abscess, or the scar is not located on the breast. 2. Active mastitis is present at enrollment, or the scar area has active infection, rupture, or ulceration. 3. Within a 10 cm range around the scar, there are skin diseases (such as eczema, psoriasis), tattoos, or significant pigmentation abnormalities that may affect the assessment. 4. History of allergy or intolerance to Jiwu Jinhuang ointment, soft ointment, or any of their components. 5. Presence of autoimmune diseases; severe cardio-cerebrovascular, respiratory, digestive, hematological, urinary, neurological, or endocrine system diseases; or moderate/severe liver or kidney dysfunction; or severe mental disorders affecting compliance. 6. Receipt of immunosuppressive therapy, biologics, systemic or local corticosteroids within the past 1 month; or participation in other interventional clinical trials. 7. Currently pregnant, planning to become pregnant, or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vancouver Scar Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient and Observer Scar Assessment Scale;scar thickness;scar area;Dermatological Quality of Life Index; | — |
Countries
China
Contacts
Public ContactSong Ping
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed