Ostomy Clinical Trial
Official title:
An Epidemiological Study of Peristomal Skin Problems in Patient With an Ostomy in Roskilde County
Peristomal skin complications are thought to be common but the exact frequency and cause of these complications are unknown. We have sought to document the incidence of cutaneous peristomal problems and to find risk factors that might contribute to peristomal complications.
Peristomal skin complications are thought to be common but the exact frequency and cause of
these complications are unknown. We have sought to document the incidence of cutaneous
peristomal problems and to find risk factors that might contribute to peristomal
complications.
A cross sectional study was conducted from September 2003 to January 2005. The study
population included all persons with an ostomy living in Roskilde County, Denmark. We have
attempted to include all persons with an ostomy by contacting the local municipalities
administering individual aid. Danish law (law of social service section 4 chapter 19 § 97)
states that every person with a chronic disease is entitled to reimbursement for any aid
needed. For ostomy patients this means that they are entitled to free stoma care products
from selected merchants and without restriction to type or manufacturer of ostomy product.
All ostomy patients are automatically enrolled in the database at the local municipality in
order to received reimbursement for product cost. It was therefore assumed that all ostomy
patients were registered, as the law provides benefits without restrictions, and
self-payment for alternative purchases would involve substantial additional and unnecessary
private expenditure for the individual ostomy patient.
A letter was sent to every ostomy patient by the municipalities, inviting them to
participate. The ostomy patients willing to participate would then return the stamped and
addressed envelope with their reply. For all patients who accepted the invitation, a
physical examination was scheduled.
At the time of the examination a detailed registration form was filled out to provide
standardised records of known risk factors and other data of possible pertinence to the
investigation.
A careful physical examination was performed by a dermatologist, a stoma care nurse
specialist and a resident. The majority of ostomy patients were seen at the dermatological
department Roskilde University Hospital, but a few were seen at their homes due to advanced
age or physical impairment. Personal details, medical histories, stoma appliances and daily
stoma care routines were recorded along with a thorough examination of the peristomal area
in regards to ostomy placemant, skin retraction, hernia, stoma height and width. A general
skin examination was also undertaken. Each variable was recorded and further documented by
colour photographs. To ensure that the participating patients correlated to the general
population, a national computer based register of all ostomy patients in Denmark were
compared to our patients in regards to ostomy type, sex, age and geographical location.
Patients with a peristomal skin problem and a control (person without a skin problem) were
selected from the cross-sectional study and invited for further examination. At this
examination several non invasive test were conducted. These non invasive test included:
D-squame tapes, Capacitans measurements , TEWL(transepidermal water loss) measurements ,
Tape stripping, Mecanical measurements of the skin and pH measurements.
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Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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