NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Presence of an ileostomy
Date of first enrollment	25/12/2025
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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