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Investigation of the Performance of Ostomy Base Plate

2014-07-24 14:06:35 | BioPortfolio

Summary

The purpose of this study is to evaluate the performance of SSH (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that SSH will do better than the two comparator products.

Description

Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new base plate (SSH) to improve security and increase comfort by minimizing leakage (seeping under the base plate) risk and thereby also the leakage related peristomal skin problems.

The purpose with this clinical study is to evaluate the effect of the new base plate on the degree of leakage under the base plate compared to two existing base plates on the market.

The study is a randomised controlled cross-over intervention study, where all study participants will test all three test products (SSH, Conform 2 and Sensura). Each test period will last 14 days. If 4 changes of base plates is not obtained during the 14 days, the test period will be prolonged until 4 base plate changes is obtained. However, the max test period of one type of product is 21 days. The participants will visit the study investigator at study start and at every shift to a new type of test product. At these visits they will answer questions about the tested product, have a peristomal skin examination and be instructed in how to use the next test products for the next treatment period. Evaluation of leakage and handling will occur via questionnaires the participants take home.

80 healthy participants with an ileostomy will be included in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ileostomy

Intervention

Investigation of performance of ostomy base plate

Location

Herlev Hospital
Herlev
Denmark
2730

Status

Recruiting

Source

Coloplast A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:06:35-0400

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During the past decade of conflict, numerous casualties sustained injuries requiring the formation of an ostomy. However, outcomes in those casualties undergoing ostomy reversal have yet to be analyze...

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Individual trials comparing hand-sewn with stapled closure of loop ileostomy show different outcomes due to lack of statistical power. A systematic review, with a pooled analysis of results, might pro...

Administration of an Oral Hydration Solution Prevents Electrolyte and Fluid Disturbances and Reduces Readmissions in Patients With a Diverting Ileostomy After Colorectal Surgery: a Prospective, Randomized, Controlled Trial.

Patients with a newly formed ileostomy often develop electrolyte abnormalities and dehydration.

Medical and Biotech [MESH] Definitions

The region in the dorsal ECTODERM of a chordate embryo that gives rise to the future CENTRAL NERVOUS SYSTEM. Tissue in the neural plate is called the neuroectoderm, often used as a synonym of neural plate.

The abrupt and unexplained death of an apparently healthy infant under one year of age, remaining unexplained after a thorough case investigation, including performance of a complete autopsy, examination of the death scene, and review of the clinical history. (Pediatr Pathol 1991 Sep-Oct;11(5):677-84)

Various mixtures of fats, waxes, animal and plant oils and solid and liquid hydrocarbons; vehicles for medicinal substances intended for external application; there are four classes: hydrocarbon base, absorption base, water-removable base and water-soluble base; several are also emollients.

Performance of an act one or more times, with a view to its fixation or improvement; any performance of an act or behavior that leads to learning.

The head of a long bone that is separated from the shaft by the epiphyseal plate until bone growth stops. At that time, the plate disappears and the head and shaft are united.

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