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Clinical study on the promotion of wound repair after anal fistula surgery with Calvatia lilacina spore powder

Clinical study on the promotion of wound repair after anal fistula surgery with Calvatia lilacina spore powder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001078
Enrollment
Unknown
Registered
2025-05-29
Start date
2023-11-15
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Postoperative wound of anal fistula

Interventions

control group:patients on the second day after surgery were routinely disinfected with 0.5% iodine cotton balls on the wound and sterilized Vaseline oil gauze was applied to the wound which was covere
treatment group:On the basis of the control group, the treatment group evenly applied 0.04 g/cm2 of CLS onto sterilized vaseline oil gauze and covered the wound.

Sponsors

Nanjing Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Traditional Chinese Medicine (Nanjing Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meets diagnostic criteria; (2) Between the ages of 18 and 60; (3) Perform anal fistula reslide after admission; (4) The external opening of the anal fistula is 2-4cm away from the anal margin; (5) The routine examination upon admission is within the normal range and there are no serious primary diseases such as cardiovascular cerebrovascular liver and kidney and blood system; (6) No history of severe drug allergies; (7) The patient agrees to the treatment plan of this project and signs a consent form and can assist in completing follow-up.

Exclusion criteria

Exclusion criteria: (1) Anal fistula caused by trauma; (2) Specific anal fistula caused by ulcerative colitis Crohn's disease tuberculosis or other unknown infections; (3) Combining diseases such as anal and rectal tumors perianal skin diseases etc; (4) Women who are pregnant breastfeeding or preparing for pregnancy; (5) Individuals with combined cardiovascular hepatic renal hematological metabolic diseases and other serious illnesses; (6) Patients who are allergic to the use of this medication; (7) Patients who use other drugs that may affect the observation of experimental results; (8) Suffering from mental illness or taking mental control medication in the past 3 months. (9) Others find it difficult to make a precise evaluation of its effectiveness and safety.

Design outcomes

Primary

MeasureTime frame
Reduction rate of wound area;Wound area;wound healing time;

Secondary

MeasureTime frame
Overall efficacy evaluation criteria;The recurrence rate of anal fistula;Wound discharge;Pain level rating;Granulation growth;

Countries

China

Contacts

Public ContactKewei Wang

Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine

kowei1231@163.com151 9598 5211

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026