Clinical trial NCT03314350: Prevalence of Wound Healing Disturbances in Geriatric Inpatients (WONDER Study)
Official title: Prevalence of Wound Healing Disturbances in Geriatric Inpatients With Specific Focus on Malnutrition, Other Nutritional Parameters and the Frailty Syndrome (WONDER Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound Healing Disorder
Malnutrition
Keywords: Geriatrics
Frailty
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 517
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Geriatric patients will be recruted upon admission to the hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of wound healing disturbances
timeFrame: Baseline
Secondary outcomes:
measure: Nutritional Parameter
timeFrame: Baseline and up to 3 weeks
measure: Functional Parameter
timeFrame: Baseline and up to 3 weeks
measure: Functional Parameter
timeFrame: Baseline and up to 3 weeks
measure: Functional Parameter
timeFrame: Baseline and up to 3 weeks
measure: Strength Parameter
timeFrame: Baseline and up to 3 weeks
measure: Strength Parameter
timeFrame: Baseline and up to 3 weeks
measure: Frailty
timeFrame: Baseline and up to 3 weeks
measure: Index of quality of life
timeFrame: Baseline and up to 3 weeks, after 3 months and after 6 months
measure: Body composition
timeFrame: Baseline and up to 3 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine, Research Group on Geriatrics
Study officials:
affiliation: Charite Research Group on Geriatrics
name: Kristina Norman, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.