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. 2023 Oct;27(10):759-765.
doi: 10.5005/jp-journals-10071-24544.

Clinical and Health Economic Evaluation of a Novel Device for Fecal Management in Bedridden Patients

Harsh Sheth  1 , Shilpa Rao  2 , V Karthik  3
Affiliations

Clinical and Health Economic Evaluation of a Novel Device for Fecal Management in Bedridden Patients

Harsh Sheth et al. Indian J Crit Care Med. 2023 Oct.

Abstract

Purpose: To evaluate the clinical effectiveness and health economic benefits of a novel indwelling lattice-based device for fecal management in bedridden patients.

Materials and methods: This nonrandomized, two-arm study included 70 bedridden patients (≥18 years exhibiting liquid stool) referred from the ICU of surgery and medicine units of a 2000-bed tertiary care referral hospital, assigned to the intervention and control groups. About 35 patients were eligible to be included in the intervention group while 35 patients with contraindications to the intervention device were included in the usual care control group. Assessments were made before and every 24 hours during the study, and all patients were closely monitored for development of incontinence-associated dermatitis (IAD) and hospital-acquired pressure injury.

Results: The test device was successfully deployed on the first attempt and effectively diverted fecal matter in all 35 patients, with no adverse events. In the control group, 83% of the patients developed IAD, which resulted in prolonged hospitalization and increased expenses. Overall, the control group (with adult diapers) required greater time, resources, and efforts for fecal management and resulted in increased patient morbidity.

Conclusion: The patient management time, resource consumption, overall cost of hospital admission, and the complication rates are significantly lower with the use of the novel lattice-based device than with the use of adult diapers for fecal management.

How to cite this article: Sheth H, Rao S, Karthik V. Clinical and Health Economic Evaluation of a Novel Device for Fecal Management in Bedridden Patients. Indian J Crit Care Med 2023;27(10):759-765.

Keywords: Balloon catheter; Critical care; Dermatitis; Diarrhea; FMS; Fecal incontinence; Fecal management; Hospital-acquired pressure injury (HAPI); Incontinence-associated dermatitis; Pressure ulcer.

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Conflict of interest statement

Source of support: The test devices used in the study are provided by Consure Medical, New Delhi, India Conflict of interest: None

Figures

Fig. 1
Fig. 1
The QoraTM Stool management kit The device includes a preloaded hygienic applicator, a fecal transit sheath for stool diversion, user-friendly access ports, and an odor-barrier collection system
Fig. 2
Fig. 2
Patient flow diagram illustrating the flow of participants through each stage of the study: enrollment, allocation, follow-up, and analysis
Figs 3A to D
Figs 3A to D
Photographs of the perineal area obtained at baseline (A) and on day 14 (B) for a representative case that received the QoraTM Stool Management Kit for fecal management. The patient's skin has remained intact throughout Photographs of the perineal area obtained at baseline (C) and on day 10 (D) for a representative case that received adult diapers for fecal management. The patient has developed severe incontinence-associated dermatitis (IAD; score, 18) because of the continuous use of adult diapers for fecal containment
See this image and copyright information in PMC

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