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OpenTrials
Completed

NCT Number: NCT01877681

Reference Nurse Program for Pressure Ulcers in Primary Care

Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care in health centers. The chronic wound care by skilled personnel is key to healing and management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC) can improve the effectiveness of interventions and cost savings.

Objective: To evaluate the effectiveness and costs reduction after the implementation in PC setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses for the management of PU in patients in home care setting.

Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza will be randomly assigned to two parallel groups: experimental group and control group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III. The intervention will consist of a telematic advice from the reference nurse regarding chronic wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of the intervention, multilevel models or linear mixed models to take into account the auto-correlation at the individual level and nurse, will be used

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Key information

Conditions

Pressure Ulcers Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New cases of PU in Stage II-III, treated by the same nurse over time at patient's home. (Stage II: Partial loss of skin thickness that affects the epidermis, dermis, or both. Ulcer surface that looks like abrasion, blister, or shallow crater; Stage III: Full thickness loss of skin involving damage or necrosis of subcutaneous tissue that may extend down to but not through the underlying fascia)

Exclusion criteria

  • Patients with chronic wounds that are not PU
  • PU in patients with plastic surgery
  • Patients who move periodically
  • Patients requiring hospitalization during follow-up
  • Patients in which nurse is expected to be changed during follow-up
  • Terminal patients

Treatment and study plan

Tele-assistance

Procedure

Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application

Active Comparator

Procedure

Usual care as specified in the PU practice guideline

Primary outcomes

  1. healing progression

    Time frame: 8 weeks

    healing progression as measured by the RESVECH scale by a blinded expert

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study title

Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2013
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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