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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03314350
• Other study ID #: WONDER
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: November 2019
• Source: Charite University, Berlin, Germany
• Contact: Kristina Norman, PD Dr.
• Phone: 0049/30450565139
• Email: kristina.norman[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 517
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Wound Healing Disorder
• Wounds and Injuries

Locations

Country	Name	City	State
Germany	Charite University Medicine, Research Group on Geriatrics	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of wound healing disturbances	Number of wound healing disturbances upon admission to the hospital in General	Baseline
Secondary	Nutritional Parameter	Mini Nutritional Assessment - Short Form (questionnaire)	Baseline and up to 3 weeks
Secondary	Functional Parameter	Timed Up & Go Test	Baseline and up to 3 weeks
Secondary	Functional Parameter	4m-walk Test to measure gait speed	Baseline and up to 3 weeks
Secondary	Functional Parameter	Lung Test to measure respiratory force	Baseline and up to 3 weeks
Secondary	Strength Parameter	Hand grip strength	Baseline and up to 3 weeks
Secondary	Strength Parameter	Knee extension strength	Baseline and up to 3 weeks
Secondary	Frailty	Frailty Status according to Fried criteria	Baseline and up to 3 weeks
Secondary	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
Secondary	Body composition	Bioelectric impedance analysis	Baseline and up to 3 weeks