Research to Evaluate Efficiency in U-health Solution Service for the Chronic Wound Management

Not Applicable

Completed

• Conditions: Pressure Ulcer
• Interventions: Device: Telemedicine system

• Registration Number: NCT02382302
• Lead Sponsor: Chan-Yeong Heo

Brief Summary

This trial is a prospective research to evaluate efficiency in U-health solution service based on Mobile for the chronic wound management.

Detailed Description

This trial conducted to assess the efficiency of teleconsultation using the smart-phone-based store-and-forward system in promoting the wound healing process as well as cost-effectiveness in patients with pressure ulcer.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-01
• Study Completion: 2012-02
• Study First Submitted: 2015-02-17
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-02
• Last Update Submitted: 2015-03-02
• Study First Posted: 2015-03-06
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Subjects who have pressure ulcer
• Subjects who voluntarily decided the participation of the study and signed the informed consent

Exclusion Criteria

• Subjects who have Osteomyelitis
• Subjects who have suppuration
• Subjects who participated in other clinical trial within 30 days from screening date

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telemedicine system	Telemedicine system	Telemedicine system

Primary Outcome Measures

Name	Time	Method
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)	4weeks post-treatment	1. Data collection; * The measurement of the size of pressure ulcer; * Medical examination;the degree of recovery of pressure ulcer; 2. Remote physician monitoring; - The patient data was transmitted from the smart-phone to the website via open application programming interface (API); 3. Prescription; 4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.

Secondary Outcome Measures

Name	Time	Method
Concordance rate for the wound and the type of dressing on the Pressure Sore Status Tool (PSST)	3weeks post-treatment	1. Data collection; * The measurement of the size of pressure ulcer; * Medical examination;the degree of recovery of pressure ulcer; 2. Remote physician monitoring; - The patient data was transmitted from the smart-phone to the website via open application programming interface (API); 3. Prescription; 4. Data analysis - One plastic surgeon, one Wound Ostomy Continence Nurse(WOCN) and one researcher grossly examined the wound sites of each patient and assessed the pressure ulcer using the revised PSST based on a 4-6 point scale.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of