Prevalence of Wound Healing Disturbances in Geriatric Inpatients (WONDER Study)

• Conditions: Wound Healing Disorder; Malnutrition

• Registration Number: NCT03314350
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

In geriatric patients, there is a plethora of nutritional and illness-related parameters, resulting in a complex situation which hampers identification of risk factors.In the planned prospective study, the point and period prevalence of wound healing disorders (WHD) is examined at admission and at discharge in a cohort of 517 male and female geriatric patients. As the investigators are also interested to study the occurrence of WHD in patients with malnutrition (and other geriatric phenomena) compared to the prevalence of WHD in patients with a good nutritional Status.

Detailed Description

The investigators will determine the prevalence of impaired wound healing upon admission to the hospital as well as the incidence of new wound healing disorders during hospital stay with specific focus on malnutrition and other important nutritional parameters in geriatric patients. Therefore the investigators intend to study consecutively admitted patients both at admission and at discharge and monitor them during hospital stay.

The investigators will investigate the associations between the individual nutritional status and body composition parameters (such as sarcopenia) and WHD in geriatric patients, taking both medical variables and the frailty syndrome into account.

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-19
• Study Start: 2017-11-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13
• Primary Completion: 2020-01-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 517

Inclusion Criteria

• Age ≥ 60 years
• Informed written consent
• Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
• Life expectancy of > 3 months according to treating doctor
• Proficient in German

Exclusion Criteria

• Lack or incapacity of informed consent
• MMSE < 24
• Life expectancy < 3 months according to assessment by the attending physician
• Short term patients (< 3 days of hospital stay)
• Lack of German language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of wound healing disturbances	Baseline	Number of wound healing disturbances upon admission to the hospital in General

Secondary Outcome Measures

Name	Time	Method
Body composition	Baseline and up to 3 weeks	Bioelectric impedance analysis
Functional Parameter	Baseline and up to 3 weeks	Lung Test to measure respiratory force
Strength Parameter	Baseline and up to 3 weeks	Knee extension strength
Index of quality of life	Baseline and up to 3 weeks, after 3 months and after 6 months	EQ-5D-5L (questionnaire) to measure quality of life
Nutritional Parameter	Baseline and up to 3 weeks	Mini Nutritional Assessment - Short Form (questionnaire)
Frailty	Baseline and up to 3 weeks	Frailty Status according to Fried criteria

Trial Locations

Locations (1)

Charite University Medicine, Research Group on Geriatrics; 🇩🇪 Berlin, Germany