peristomal complication
Conditions
Interventions
Experimental group:Deshutuo two-piece ostomy appliance
Control group:SenSura two-piece ostomy appliance
Sponsors
Hu'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. Patients in the perioperative period after the first elective single cavity colostomy at each study center; 3. The seated stoma height of the patient was >=0.5cm above the skin surface; 4. The DET score of periostomy dermatitis was 0; 5. Karnofsky score >=70; 6. The local conditions of the stoma meet the requirements of using the planar chassis; 7. The patient participated in the experiment voluntarily and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic to any product used in the test or allergic to two or more drugs, foods, etc.; 2. Patients who need reoperation due to any disease after ostomy; 3. Patients in the stage of acute infection, surgical incision infection, lung infection and other severe infections; 4. Patients with existing underlying diseases (such as diabetes, chronic obstructive pulmonary disease, hypertension, cerebral infarction, coronary heart disease, etc.) have not been effectively controlled, and are judged by researchers to be unfit to participate in this study; 5. Patients with mental abnormality or unstable condition; 6. Patients with a history of drug abuse, drug abuse, and serious infectious disease are still clinically significant according to researchers' judgment; 7. Pregnant and lactating patients and those who have recently planned to give birth; 8. Patients have participated in clinical trials of other medical devices within 1 month before screening or clinical trials of other drugs within 3 months before screening; 9. Due to various subjective and objective factors, patients and their families cannot cooperate with research; 10. Patients deemed unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 - peristomal dermatitis rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseplate leakage degree;Average lasting period of the baseplate;Economic parameters;Patient satisfactory degree; | — |
Countries
China
Contacts
Public ContactShen Yongyi
Hu'nan Cancer Hospital
Outcome results
None listed