Complications of stoma
Conditions
Interventions
Test group:32-point leakage method, using desudol ? Two piece stoma care product
control group:32-point leakage method, using shengshu ? Two piece stoma care product
Sponsors
Hefei First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1: 1.Male or female aged = 18 years old 2: 2.Patients undergoing ostomy at various research centers 3: 3.Patients with DET score of 0 for periostomy dermatitis 4: 4.The local condition of the stoma meets the requirements for using a convex chassis 5: 5.The patient voluntarily participated in this trial and signed an informed consent form
Exclusion criteria
Exclusion criteria: 1: 1.Individuals who are allergic to any product used in the experiment or have a history of allergies to two or more drugs, foods, etc 2: 2.Those who need to undergo another surgery due to any other disease after ostomy 3: 3.Patients in the acute infection stage, surgical incision infections, lung infections, and other severe infections 4: 4.Those who have not been effectively controlled due to the merger of existing underlying diseases and have been determined by the researchers to be unsuitable for participating in this trial 5: 5.Patients with mental disorders or unstable conditions 6: 6.Individuals with a history of drug abuse, drug abuse, or severe infectious diseases that have been determined by researchers to be clinically significant 7: 7. Pregnant and lactating women 8: 8.Individuals who have participated in clinical trials of other medical devices within one month prior to screening or have participated in clinical trials of other drugs within three months prior to screening 9: 9.Due to various subjective and objective factors, patients and their families are unable to cooperate with the researchers 10: 10.Patients judged by the researchers to be unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chassis leakage rate;Residual adhesive rate of chassis;Comfort;viscosity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of dermatitis;Average service time of stoma chassis;Economic indicators;patient satisfaction; | — |
Countries
China
Contacts
Public ContactWang shengqin
Hefei First People's Hospital
Outcome results
None listed