peristomal skin complication
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 80 years; 2.Underwent ileostomy within <=7 days and had no peristomal skin damage before enrollment; 3.Absence of severe cardiopulmonary diseases or other major systemic diseases; 4.No cognitive or communication impairments, voluntarily participated and signed informed consent, and were willing to adhere to the intervention protocol and complete all follow-up visits;
Exclusion criteria
Exclusion criteria: 1.Patients with known allergy to the liquid skin barrier used in this study; 2.Patients with advanced tumors or those undergoing reoperation due to anastomotic leakage after enterostomy; 3.Patients with contraindications to the use of the investigational device at the stoma site, deemed unsuitable for participation in this trial by the investigator; 4.Participation in other device or drug studies during the screening period or within 30 days prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of peristomal skin complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peristomal skin condition;Unplanned stoma appliance leakage rate;Patient satisfaction;Quality of life;Duration of stoma care procedure; | — |
Countries
China
Contacts
The First Affiliated Hospital of Zhejiang University School of Medicine