Pressure UlcerNCT03685929
Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis
An observational study of Pressure Ulcer and Incontinence-associated Dermatitis, run by University Ghent at 1 site in Belgium.
Trial summary
This study aims to identify differences and similarities between superficial pressure ulcers (category II and III) and incontinence-associated dermatitis (category IIA) at tissue level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Incontinence-associated Dermatitis, Irritant Contact Dermatitis
- What is being tested?
- Punch skin biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted on following wards of a university hospital * Pneumology * Gastroenterology * Endocrinology * Nephrology * Neurology * Geriatrics * Gastrointestinal surgery
Who may be able to join
- Incontinent for urine, stool, or both
- Superficial pressure ulcer (category II or III) and/or incontinence-associated dermatitis (category IIA)
- Expected length of stay of 7 days following punch skin biopsy
Who cannot join
- Skin infection at biopsy site
- Medical contraindication to obtain a biopsy
- End of life care
- Not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to identify differences and similarities between superficial pressure ulcers (category II and III) and incontinence-associated dermatitis (category IIA) at tissue level.
Skin biopsies will be obtained from 30 patients with pressure ulcers (n = 10), incontinence-associated dermatitis (n = 10), and combined lesions (n = 10).
The results from the histopathologic examination will be compared with the clinical diagnosis by wound care experts, which will be based on photographs and relevant patients' characteristics.
Read the detailed description
Despite current preventive strategies, prevalence of pressure ulcers and incontinence-associated dermatitis (IAD) is still estimated at 5.9-6.9% in hospitalised patients, and 5.0-5.9 in home care patients. Both skin conditions may occur in the same body region but are considered as separate entities, based on differences in etiology.
At tissue level, it is assumed that pressure ulcers are characterised by ischemia and tissue deformation. In contrast, IAD is assumed to be characterised by an irritative pattern. These assumptions are reflected in current preventive strategies. However, a small scale study, performed by Houwing et al. (2007), described the additional presence of an ischemic pattern in patients with IAD. More insights into the histopathologic pattern of pressure ulcers and IAD is needed to optimise current preventive strategies.
Tha aim of this study is to compare superficial pressure ulcers (category II and III) and IAD (category IIA) at tissue level.
A prospective interventional study will be performed during which skin biopsies (punch biopsies) will be collected from 30 incontinent patients. In each patient patient, two punch skin biopsies will be performed, one at the border of the skin lesion and one at the adjacent healthy skin. Sections from the biopsies will be stained with hematoxiline and eosine and examined by two independently working, blinded skin pathologists. In addition, photographs from the skin lesions will be analysed by 10 national and international wound care experts to promote correct diagnosis. Finally, findings from the histopathologic examination will be compared with the clinical diagnoses based on photographs.
- Conditions
- Pressure Ulcer, Incontinence-associated Dermatitis, Irritant Contact Dermatitis, Diaper Rash
- Being tested
- Punch skin biopsy
- Keywords
- Pressure ulcer, Incontinence-associated dermatitis, Histopathology, Ischemia, Irritation, Prevention, Tissue, Skin
- Medical subject headings
- Pressure Ulcer, Dermatitis, Irritant, Diaper Rash, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch skin biopsyProcedure or surgery
Two punch biopsies will be performed in each patient, one at the border of the skin lesion, and one at the adjacent healthy skin. A disposable biopsy punch of 4 mm will be used. A biopsy punch is a small circular blade (like an apple corer) which is rotated into the skin to obtain a cylindrical specimen. Local anaesthesia will be applied and the circular wound will be closed by a single suture. Sutures will be removed after one week.
| Study group | Role | What they receive |
|---|---|---|
| Pressure ulcers | Patients with pressure ulcers category II/III at sacrum or trochanter Receives: Procedure: Punch skin biopsy | |
| Incontinence-associated dermatitis | Patients with incontinence-associated dermatitis category IIA at sacrum (or trochanter) Receives: Procedure: Punch skin biopsy | |
| Combined lesion | Patients with pressure ulcer category II/III and incontinence-associated dermatitis category IIA at sacrum or trochanter Receives: Procedure: Punch skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pressure ulcers and incontinence-associated dermatitis
Presence of pressure ulcers and/or incontinence-associated dermatitis based on photographs and patient characteristics
Measured: 1 day
Histopathologic pattern
Characteristics of epidermis, dermis, and subcutis based on histopathologic examination
Measured: 1 day
Secondary outcomes (1)
Rate of agreement between visual and histopathologic diagnosis
Agreement between diagnosis of wound care experts (based on photographs), and diagnosis by skin pathologists (based on histopathologic examination)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Sofie De Schepper, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685929
- Sponsor's protocol ID
- 2018/0946
- Status last verified
- Nov 2021
- First submitted
- 24 Sep 2018
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
PubMed 27841440
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis
- ClinicalTrials.gov ID
- NCT03685929
- Acronym / sponsor ID
- 2018/0946
- Conditions
- Pressure Ulcer, Incontinence-associated Dermatitis, Irritant Contact Dermatitis, Diaper Rash
- Keywords
- Pressure ulcer, Incontinence-associated dermatitis, Histopathology, Ischemia, Irritation, Prevention, Tissue, Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify differences and similarities between superficial pressure ulcers (category II and III) and incontinence-associated dermatitis (category IIA) at tissue level.
Skin biopsies will be obtained from 30 patients with pressure ulcers (n = 10), incontinence-associated dermatitis (n = 10), and combined lesions (n = 10).
The results from the histopathologic examination will be compared with the clinical diagnosis by wound care experts, which will be based on photographs and relevant patients' characteristics.
Detailed description
Despite current preventive strategies, prevalence of pressure ulcers and incontinence-associated dermatitis (IAD) is still estimated at 5.9-6.9% in hospitalised patients, and 5.0-5.9 in home care patients. Both skin conditions may occur in the same body region but are considered as separate entities, based on differences in etiology.
At tissue level, it is assumed that pressure ulcers are characterised by ischemia and tissue deformation. In contrast, IAD is assumed to be characterised by an irritative pattern. These assumptions are reflected in current preventive strategies. However, a small scale study, performed by Houwing et al. (2007), described the additional presence of an ischemic pattern in patients with IAD. More insights into the histopathologic pattern of pressure ulcers and IAD is needed to optimise current preventive strategies.
Tha aim of this study is to compare superficial pressure ulcers (category II and III) and IAD (category IIA) at tissue level.
A prospective interventional study will be performed during which skin biopsies (punch biopsies) will be collected from 30 incontinent patients. In each patient patient, two punch skin biopsies will be performed, one at the border of the skin lesion and one at the adjacent healthy skin. Sections from the biopsies will be stained with hematoxiline and eosine and examined by two independently working, blinded skin pathologists. In addition, photographs from the skin lesions will be analysed by 10 national and international wound care experts to promote correct diagnosis. Finally, findings from the histopathologic examination will be compared with the clinical diagnoses based on photographs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pressure ulcers | – | Procedure: Punch skin biopsyPatients with pressure ulcers category II/III at sacrum or trochanter |
| Incontinence-associated dermatitis | – | Procedure: Punch skin biopsyPatients with incontinence-associated dermatitis category IIA at sacrum (or trochanter) |
| Combined lesion | – | Procedure: Punch skin biopsyPatients with pressure ulcer category II/III and incontinence-associated dermatitis category IIA at sacrum or trochanter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted on following wards of a university hospital * Pneumology * Gastroenterology * Endocrinology * Nephrology * Neurology * Geriatrics * Gastrointestinal surgery
Key inclusion criteria (3 listed)
- Incontinent for urine, stool, or both
- Superficial pressure ulcer (category II or III) and/or incontinence-associated dermatitis (category IIA)
- Expected length of stay of 7 days following punch skin biopsy
Key exclusion criteria (4 listed)
- Skin infection at biopsy site
- Medical contraindication to obtain a biopsy
- End of life care
- Not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Punch skin biopsyTwo punch biopsies will be performed in each patient, one at the border of the skin lesion, and one at the adjacent healthy skin. A disposable biopsy punch of 4 mm will be used. A biopsy punch is a small circular blade (like an apple corer) which is rotated into the skin to obtain a cylindrical specimen. Local anaesthesia will be applied and the circular wound will be closed by a single suture. Sutures will be removed after one week. | Procedure or surgery | Combined lesion, Incontinence-associated dermatitis, Pressure ulcers |
Primary outcome
Prevalence of pressure ulcers and incontinence-associated dermatitis
Time frame: 1 day
Presence of pressure ulcers and/or incontinence-associated dermatitis based on photographs and patient characteristics
Histopathologic pattern
Time frame: 1 day
Characteristics of epidermis, dermis, and subcutis based on histopathologic examination
1 secondary outcome
Rate of agreement between visual and histopathologic diagnosis
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Background: PubMed 27841440Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
- Website of the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofie De Schepper principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer and Incontinence-associated Dermatitis, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pressure ulcers and incontinence-associated dermatitis (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.