Effects by Omission of Bandage Over Exit Site

NCT02102425 | Unknown DMC

• 1 other identifier: N-20130076
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Peritoneal dialysis, known as p- dialysis (PD), is a dialysis form in which the blood is purified by using the body's peritoneum. PD dependents on good access to peritoneum. For this, a catheter is implanted in the peritoneum and tunneled 2-3 cm below the skin. The way out is called exit site and is close to the navel. Patients are selected at random to use bandage or not use bandage for three months, then cross-over. The overall objective of the research is that the patient in PD maintains a complete and healthy skin without signs of infection around the exit site. In the study effects by omission of bandage over exit site at patients in PD are examined when the patients are in a stable process with PD. The patient's exit site is assessed according to skin character and examined for infection. The hypothesis is that there is no greater rate of infection in patients without bandage than in patients with bandage over the exit site, and that patients without bandage will have stronger skin around exit site.

Conditions

Renal Insufficiency, Chronic

Keywords

Peritoneal Dialysis; Exit site infection; Exit site care; Bandage; Prevention; Guidelines

Outcome Measures

Primary Outcomes (1)

• Healthy unbroken skin

  The primary endpoint is the condition of the skin around the exit site as measured by Sunnybrook PD Catheter Exit Site Assessment Tool prepared by Patsy Cho and colleagues. Following parameters are recorded: Redness, crust, swelling, pain, secretion.

  The patient is assessed after 6 months.

Secondary Outcomes (1)

• Infection

  The patient is assessed efter 6 months

Other Outcomes (1)

• Patient's experience of the exit site with or without bandage

  Questionnaire after 6 months

Study Arms (1)

Chronic kidney disease, PD

Patients with or without bandage over exit site

Procedure: Patients with or without bandage over exit site

Interventions

Patients with or without bandage over exit site PROCEDURE

Chronic kidney disease, PD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Nurses in the PD clinic at Aalborg University Hospital might have observed that patients without bandage do not get more infections around the exit site in relation to the patients using bandage. However, the study should develop evidence guidelines.

You may qualify if:

• Patients with uraemia chronic classified by ICD10 kode DN189. The patients are in stable PD. Talk og understand Danish.

You may not qualify if:

• Special reasons for protection of the exit site (- eg. critical illness, stay in areas with high risk of infection or body movements that require special fixation of the exit site) Mental impairment.
• Symptoms of eczema around the exit site.

Sponsors & Collaborators

• Edith Mark: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

PD-ambulatorium, Clinical Nursing Research Unit/Department of Nephrology, Aalborg University Hospital,

Aalborg, 9000, Denmark

RECRUITING

Related Links

• Clinical Nursing Research Unit, Aalborg University Hospital, Denmark

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erik E Sørensen, PhD Nursing

  Clinical Nursing Research Unit, Aalborg University Hospital, Denmark

  STUDY CHAIR

Central Study Contacts

Birgitte S Laursen, PhD

CONTACT

+45 22 40 87 63; bisl@rn.dk

Erik E Sørensen, PhD

CONTACT

+45 97 66 62 83; ees@rn.dk

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postdoc in Clinical Nursing

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: April 3, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2017
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

DK (1)