Effects of Different Support Surfaces on the Properties Skin After Loading

NCT02930590 | Completed Results

• 1 other identifier: CRC-PU-A-23
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).

Conditions

Pressure Ulcers

Outcome Measures

Primary Outcomes (6)

• Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline

  TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).

  at baseline

• Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading

  TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).

  after two hours loading

• Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading

  TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).

  20 min after off-loading

• Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline

  TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).

  at baseline

• Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading

  TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).

  after two hours loading

• Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading

  TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).

  20 min after off-loading

Secondary Outcomes (88)

• Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline

  at baseline

• Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours

  after two hours

• Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading

  20 minutes after off-loading

• Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline

  at baseline

• Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading

  after two hours loading

Study Arms (3)

Low Pressure mattress

EXPERIMENTAL

Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA)

Other: Alternating low pressure mattress with air loss function

Reactive support surface

EXPERIMENTAL

Gel mattress (IsoGel, stryker, USA)

Other: Gel mattress

Standard mattress

ACTIVE COMPARATOR

basic foam

Other: Basic foam

Interventions

Alternating low pressure mattress with air loss function OTHER

IsoAir, Stryker, USA

Low Pressure mattress

Gel mattress OTHER

IsoGel, Stryker, USA

Reactive support surface

Basic foam OTHER

Standard hospital mattress

Standard mattress

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, female volunteers
• to 80 years
• Body Mass Index between 18.5 and 29.9 kg/m2
• Non-Smoker of at least one year
• Absence of skin diseases or scars in the skin areas of interest
• Ability to move independently and to maintain supine and prone positions
• Able to give written informed consent
• No use of cosmetic products or topical applied drugs on the study areas at least 12 hours before measurement
• Skin phototype I to III according to Fitzpatrick classification
• Willing and able to fulfil the study requirements

You may not qualify if:

• Disability to maintain in supine or prone position
• Acute diseases
• Acute or chronic diseases with increased or decreased body temperature (≤ 35°C or ≥ 38,5°C, measured in the ear)
• History or establishment of Diabetes or pre-diabetes, cardiac or renal insufficiency, atopic dermatitis, psoriasis, chronic obstructive pulmonary disease (COPD)
• Acute or chronic wounds in the skin areas of interest
• Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites
• Current participation in any other clinical study

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• Tomova-Simitchieva T, Lichterfeld-Kottner A, Blume-Peytavi U, Kottner J. Comparing the effects of 3 different pressure ulcer prevention support surfaces on the structure and function of heel and sacral skin: An exploratory cross-over trial. Int Wound J. 2018 Jun;15(3):429-437. doi: 10.1111/iwj.12883. Epub 2017 Dec 26.

  PMID: 29277963 RESULT

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Jan Kottner
• Organization: Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin

jan.kottner@charite.de

+49 30 450 518218

Study Officials

• Jan Kottner, PD Dr.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 12, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 14, 2022
• Results First Posted: October 23, 2018

Record last verified: 2022-05

Locations

DE (1)