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A prospective, single-center, randomized controlled clinical trial on the safety and efficacy of light-cured wound closure adhesives for postoperative wounds after pilonidal sinuses surgery

A prospective, single-center, randomized controlled clinical trial on the safety and efficacy of light-cured wound closure adhesives for postoperative wounds after pilonidal sinuses surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109622
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

pilonidal sinuses

Interventions

Test group:Following completion of the pilonidal sinus excision, the wound surface was irrigated with metronidazole solution for sterilization and dried with sterile gauze. Subsequently, light-curing
Control group:Following completion of the pilonidal sinus excision, the wound surface was irrigated with metronidazole solution for sterilization and dried with sterile gauze. Postoperative sitz bath

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of pilonidal sinus; 2. Those who have no contraindications to surgery and plan to undergo hidden pilonidal sinusotomy in the Department of Anorectal Hospital of Yueyang Hospital; 3. Age >=18 years old and <=65 years old, gender is not limited; 4. Understand and agree to participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of Crohn's disease, ulcerative colitis, intestinal tuberculosis or other tumors and immune diseases; 2. Have serious heart, liver, kidney, lung insufficiency and other diseases; 3. Those with a history of uncontrollable mental illness; 4. Subjects with uncontrolled diabetes mellitus or diseases or conditions known to affect the wound healing process; 5. Those who are known to be allergic to the light-cured wound sealing adhesive components; 6. Need to use additional drugs or devices such as topical growth factors that affect wound healing in the test area; 7. Participated in or is participating in other clinical studies in the past 3 months; 8. Any history of the possibility of interfering with the results of the trial or increasing the risk to the patient according to the investigator's judgment.

Design outcomes

Primary

MeasureTime frame
The cure rate of wound healing 42 days after the operation;

Secondary

MeasureTime frame
Wound healing time;Postoperative wound pain scores, defecation pain score, walking pain score;The dosage of analgesic drugs within 7 days after the operation;Wound exudate;

Countries

China

Contacts

Public ContactChangpeng Han

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to 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