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A prospective, single-center, controlled clinical trial on the safety and efficacy of light-curing wound sealant in the postoperative wound treatment of anorectal disease

A prospective, single-center, controlled clinical trial on the safety and efficacy of light-curing wound sealant in the postoperative wound treatment of anorectal disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093492
Enrollment
Unknown
Registered
2024-12-05
Start date
2024-12-06
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Anal fistula

Interventions

Test group:Intraoperative management: The patient first underwent classical anal fistula resection. After the operation, the wound was rinsed and sterilized with metronidazole solution and dried with
Control group:Intraoperative management: The patient first underwent classical anal fistula resection. After the operation, the wound was filled with dressing and bandaged, and the dressing was covere

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with adenogenous anal fistula with imaging examination(MRI) consistent with the intersphincteric and transsphincteric types of Park's classification, with a single and straight fistula with an external opening of less than 5 cm in length from the anal verge; 2. The fistula is in the stable stage; 3.There is no contraindication to surgery, and it is proposed to perform classical anal fistula resection in the Department of Proctology of Yueyang Hospital; 4. Age = 18 years and = 65 years, gender is not limited; 5. Understand and agree to participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with a combined history of other anorectal diseases or a history of surgery (including colorectal malignancy, Crohn's disease, ulcerative colitis, intestinal tuberculosis, etc.). 2. Patients with contraindications to surgery (e.g. those with hematopoietic and coagulation disorders, patients in pregnancy or lactation); 3.Those with serious heart, liver, kidney, lung insufficiency and other diseases; 4.Those with a history of uncontrollable psychosis; 5. Subjects with uncontrolled diabetes or diseases or conditions known to affect the wound healing process; 6. Persons with a known allergy to the components of this medical bioadhesive. 7. Subjects who require additional use of drugs or devices that affect wound healing, such as topical growth factors, in the test area; 8.Have participated or are participating in other clinical studies in the last 3 months; 9.Any medical history that, in the judgment of the investigator, is likely to interfere with the results of the trial or increase the risk to the patient.

Design outcomes

Primary

MeasureTime frame
Cure rate of wound healing at 18 days postoperatively;

Secondary

MeasureTime frame
Wound healing time;Postoperative pain;Postoperative wound edema;Skin allergy;Wound infection;

Countries

China

Contacts

Public ContactHan Changpeng

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

13918314533@163.com+86 139 1831 4533

Outcome results

None listed

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