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

Prevalence of Wound Healing Disturbances in Geriatric Inpatients With Specific Focus on Malnutrition, Other Nutritional Parameters and the Frailty Syndrome (WONDER Study)

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.

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Wound Healing Disorder

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 Type: Observational
• Enrollment (Anticipated): 517

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13347
    • Recruiting
    • Charite University Medicine, Research Group on Geriatrics
    • Contact: Kristina Norman, PD Dr.; Phone Number: +4930450565139; Email: kristina.norman@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Geriatric patients will be recruted upon admission to the hospital.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of wound healing disturbances	Number of wound healing disturbances upon admission to the hospital in General	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Parameter	Mini Nutritional Assessment - Short Form (questionnaire)	Baseline and up to 3 weeks
Functional Parameter	Timed Up & Go Test	Baseline and up to 3 weeks
Functional Parameter	4m-walk Test to measure gait speed	Baseline and up to 3 weeks
Functional Parameter	Lung Test to measure respiratory force	Baseline and up to 3 weeks
Strength Parameter	Hand grip strength	Baseline and up to 3 weeks
Strength Parameter	Knee extension strength	Baseline and up to 3 weeks
Frailty	Frailty Status according to Fried criteria	Baseline and up to 3 weeks
Index of quality of life	EQ-5D-5L (questionnaire) to measure quality of life	Baseline and up to 3 weeks, after 3 months and after 6 months
Body composition	Bioelectric impedance analysis	Baseline and up to 3 weeks

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Shahin ES, Meijers JM, Schols JM, Tannen A, Halfens RJ, Dassen T. The relationship between malnutrition parameters and pressure ulcers in hospitals and nursing homes. Nutrition. 2010 Sep;26(9):886-9. doi: 10.1016/j.nut.2010.01.016. Epub 2010 May 4.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Geriatrics; Frailty
• Additional Relevant MeSH Terms: Nutrition Disorders; Wounds and Injuries; Malnutrition
• Other Study ID Numbers: WONDER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No