Scar, hypertrophic scar, keloid
Conditions
Interventions
A group:Diclofenac diethylamine
B group:Silicone
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 65 years old, gender not limited. 2. Planned to undergo or have already undergone elective, clean plastic surgery (such as breast surgery, resection of surface tumors, etc.), with an incision length of 1 to 10cm and a linear incision. 3. Participate voluntarily and sign a written informed consent form. 4. Be able to understand the research requirements and commit to follow-up visits on time.
Exclusion criteria
Exclusion criteria: 1. Related to the subjects: (1). Those who are known to be allergic to the study drug or its components. (2). Those with a history of keloids or a pathological keloid-prone constitution. (3). Pregnant women, lactating women, or those planning to get pregnant during the research period. (4). Suffering from severe systemic diseases (such as heart, liver and kidney insufficiency, active peptic ulcers, hemorrhagic diseases). (5). Those with a history of asthma, urticaria or allergic rhinitis induced by NSAIDs. 2. Related to the lesion: (1). The research incision is located in high-tension or easily friction-prone areas such as joints and the chest. (2). There is active infection, hematoma, dehiscence or poor healing at the incision. (3). The incision is a scar after a burn, a chronic ulcer or a cancerous wound. 3. Exclusion criteria related to combined medication: (1). During the study period, any other treatment that affects the scar (such as hormone injection, laser, radiotherapy, etc.) is planned to be used in the study incision area. (2). Those who are taking oral anticoagulants, glucocorticoids or other NSAIDs for a long time (occasional use is allowed, but it needs to be recorded).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total score of the Vancouver Scar Scale (VSS) for incision scars; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total score change of the Vancouver Scar Scale (VSS) for incision scars;Score of the Global Aesthetic Improvement Scale (GAIS);Score of the Visual Analogue Scale for Itching/Pain (VAS);Safety endpoint;Transcutaneous water loss rate (TEWL) and skin elasticity;Patient Scar Self-Assessment Scale (PSAS); | — |
Countries
China
Contacts
Public ContactShen Zeren
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed