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Exploratory study related to 222 nm UV-C irradiation for ileostomy closure

Exploratory study related to 222 nm UV-C irradiation for ileostomy closure - Expras222

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042250154
Enrollment
20
Registered
2025-12-25
Start date
2026-05-12
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Presence of an ileostomy

Interventions

During ileostomy closure surgery, after closure of the anterior rectus sheath, the surgical wound will be irradiated with 222-nm ultraviolet light. The irradiation dose will be 500 mJ/cm2 per exposure

Sponsors

Mayu Sakata
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older 2. Patients scheduled to undergo ileostomy closure. 3. Patients who have provided written informed consent by personally signing the consent form for this study.

Exclusion criteria

Exclusion criteria: 1. Patients with allergies to dressings, adhesive bandages, or similar products 2. Patients with allergy to povidone-iodine 3. Patients with allergy to triclosan 4. Patients with a history of xeroderma pigmentosum 5. Patients with a history of photosensitivity 6. Patients currently under treatment for abdominal skin diseases 7. Patients with poorly controlled diabetes mellitus, defined as HbA1c of 8.0 % or higher within 90 days prior to enrollment 8. Patients with a history of smoking within 28 days prior to enrollment 9. Patients with a history of wound dehiscence following previous abdominal surgery. 10. Patients in a state of malnutrition, defined as meeting any of the following: a weight loss of 10 % or more within 6 months prior to registration, a BMI less than 18.5 kg/m2 at enrollment, or a preoperative serum albumin level less than 3.0 g/dL. 11. Patients receiving systemic steroids or immunosuppressants (excluding topical or inhaled agents) within 90 days prior to enrollment 12. Patients who are pregnant, breastfeeding, or may be pregnant 13. Patients who have undergone another surgical procedure within 30 days prior to enrollment 14. Patients deemed inappropriate for participation by the principal investigator or sub-investigators

Design outcomes

Primary

MeasureTime frame
The incidence of anterior rectus sheath dehiscence classified as Clavien-Dindo Grade IIIa or higher within 30 days after surgery.

Secondary

MeasureTime frame
Incidence of superficial surgical site infection (SSI) classified as Clavien-Dindo Grade II or higher Bacterial species identified at the wound site Postoperative length of hospital stay, defined as the period from the day of surgery to the day the physician determines the patient is eligible for discharge. Erythema in the irradiated area Formation of cyclobutane pyrimidine dimers (CPDs) in irradiated tissues Adverse events potentially related to UV irradiation, excluding superficial SSI and erythema in the irradiated area Device malfunctions

Contacts

Public ContactTakagi Toru

Hamamatsu University School of Medicine

D23011@hama-med.ac.jp+81-53-435-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026