Anal Fistula
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Aged 18-65 years, any gender 2)Meet the above diagnostic criteria 3)Normal anal anatomy and function with no history of anorectal surgery (except incision and drainage of perianal abscess) 4)Postoperative wound area between 9-15 cm² 5)Agree to refrain from concomitant therapies or clinical trials that may interfere with this study 6)Signed informed consent with voluntary acceptance of surgical treatment
Exclusion criteria
Exclusion criteria: 1)Pregnant or lactating women 2)Patients with inflammatory bowel disease or fistula-associated complications/confounding diseases 3)Clinically significant abnormalities or medical histories deemed ineligible by investigators, including but not limited to: Neurological, cardiovascular, hematological/lymphatic, immunological, endocrine, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems disorders History of malignant tumors 4)Known hypersensitivity to investigational product or excipients 5)Other conditions that may affect compliance or render participation unsuitable per investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients with Wound Healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound Healing Time;Granulation Tissue Quality Score;Wound Exudate Assessment Score;Resting and Post-Defecation Pain NRS Scores in the Morning;Wound Pruritus Assessment Score;Bleeding Assessment Score; | — |
Countries
China
Contacts
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine