NCT00391508

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
Last Updated

October 24, 2006

Status Verified

October 1, 2006

First QC Date

October 23, 2006

Last Update Submit

October 23, 2006

Conditions

OstomyLiving in Roskilde CountyPersons More Than 18 Years of AgeWillingness to Participate

Keywords

OstomyPeristomal skinSkin complication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ostomy
  • Living in Roskilde County
  • Persons more than 18 years of age
  • Willingness to participate

You may not qualify if:

  • Under 18 years of age
  • Living outside Roskilde County
  • If not able to comprehend the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roskilde University Hospital, Dept. of Dermatology

Dk-4000 Roskilde, 4000, Denmark

Location

Study Officials

  • Hanne Nybaek, MD

    Dept. of Dermatology, Roskilde Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 24, 2006

Study Start

September 1, 2003

Study Completion

August 1, 2005

Last Updated

October 24, 2006

Record last verified: 2006-10

Locations

DK(1)