Health Condition 1: null- Loss of bowel control
Conditions
Interventions
Intervention1: Qora SMK: Closed Stool Containment Device
Control Intervention1: NIL: NIL
Sponsors
Consure Medical Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male and female non-ambulatory, hospitalized patients, 18+ years of age. Patient or a legal representative of the patient gives written consent for study. Patient has history of passage of at least 1 episode of liquid or semi-liquid stool (Bristol Type 6-7) in past 24 hours. Patients satisfying ANY ONE of the following two conditions: a. Patients having liquid stool (Bristol stool type 7); e.g. antibiotic induced diarrhoea, C diff, lactulose regime b. Patients with pre-existing perineal pressure ulcer and/or open wound where stool diversion can assist in recovery of the pressure ulcer and/or open wound AND patients can be given enema before insertion of the device and thereafter can be given stool softeners to keep the stool consistency liquid/semi-solid (Bristol stool type 5-7. See Appendix D â?? Bristol Stool Chart) Patient is anticipated stay in the care facility for a minimum three days period after being enrolled into the study
Exclusion criteria
Exclusion criteria: Enrolled in another clinical study or clinical trial Has suspected or confirmed rectal mucosal impairment or pathology, i.e. severe proctitis, ischemic proctitis, mucosal ulcerations Has had rectal surgery within the last year Has any rectal bleeding or anal injury Has haemorrhoids of significant size Has a rectal or anal stricture or stenosis Has or suspected to have tumour(s) in the rectum or anal canal Has or suspected to have impacted stool Has or suspected to have constipation Has any indwelling rectal or anal device or delivery mechanism in place Critically ill patients unlikely to survive first three days of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate caregiver acceptability of Qora Aeon Stool Management System (SMK) in terms of its utility, ease and comfort as judged by the caregiver.Timepoint: End of patient enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the utility of Qora Aeon (SMK) in the healing process of patients with preexisting perennial pressure ulcer and/or other open wounds.Timepoint: End of patient enrolment | — |
Countries
India
Contacts
Public ContactAmit Sharma
Consure Medical
Outcome results
None listed