OstomyNCT00391508
Skin Problems in Ostomy Patients: An Epidemiological Study
An observational study of Ostomy and Living in Roskilde County, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ostomy, Living in Roskilde County, Persons More Than 18 Years of Age
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2003to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ostomy
- Living in Roskilde County
- Persons more than 18 years of age
- Willingness to participate
Who cannot join
- Under 18 years of age
- Living outside Roskilde County
- If not able to comprehend the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Roskilde University Hospital, Dept. of Dermatology
Dk-4000 Roskilde, 4000
About this study
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.
Read the detailed description
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.
- Conditions
- Ostomy, Living in Roskilde County, Persons More Than 18 Years of Age, Willingness to Participate
- Keywords
- Ostomy, Peristomal skin, Skin complication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startSep 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S
- Investigators
- Hanne Nybaek, MD, Principal investigator, Dept. of Dermatology, Roskilde Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391508
- Sponsor's protocol ID
- Sept-HN-2003
- Status last verified
- Oct 2006
- First submitted
- 23 Oct 2006
- Last updated
- 24 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Study of Peristomal Skin Problems in Patient With an Ostomy in Roskilde County
- ClinicalTrials.gov ID
- NCT00391508
- Acronym / sponsor ID
- Sept-HN-2003
- Conditions
- Ostomy, Living in Roskilde County, Persons More Than 18 Years of Age, Willingness to Participate
- Keywords
- Ostomy, Peristomal skin, Skin complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Coloplast A/S
- Study start
- Sep 2003
- Study completion
- Aug 2005
- First posted
- 24 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ostomy
- Living in Roskilde County
- Persons more than 18 years of age
- Willingness to participate
Key exclusion criteria (3 listed)
- Under 18 years of age
- Living outside Roskilde County
- If not able to comprehend the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2006.
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Novel Post-Surgical Incision Management to Prevent Ostomy Complications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Nybaek, MD principal investigator
Dept. of Dermatology, Roskilde Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ostomy and Living in Roskilde County, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2006.