NCT03685929

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

September 24, 2018

Last Update Submit

November 26, 2021

Conditions

Pressure UlcerIncontinence-associated DermatitisIrritant Contact DermatitisDiaper Rash

Keywords

Pressure ulcerIncontinence-associated dermatitisHistopathologyIschemiaIrritationPreventionTissueSkin

Outcome Measures

Primary Outcomes (2)

  • Prevalence of pressure ulcers and incontinence-associated dermatitis

    Presence of pressure ulcers and/or incontinence-associated dermatitis based on photographs and patient characteristics

    1 day

  • Histopathologic pattern

    Characteristics of epidermis, dermis, and subcutis based on histopathologic examination

    1 day

Secondary Outcomes (1)

  • Rate of agreement between visual and histopathologic diagnosis

    1 day

Study Arms (3)

Pressure ulcers

Patients with pressure ulcers category II/III at sacrum or trochanter

Procedure: Punch skin biopsy

Incontinence-associated dermatitis

Patients with incontinence-associated dermatitis category IIA at sacrum (or trochanter)

Procedure: Punch skin biopsy

Combined lesion

Patients with pressure ulcer category II/III and incontinence-associated dermatitis category IIA at sacrum or trochanter

Procedure: Punch skin biopsy

Interventions

Punch skin biopsyPROCEDURE

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.

Combined lesionIncontinence-associated dermatitisPressure ulcers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted on following wards of a university hospital * Pneumology * Gastroenterology * Endocrinology * Nephrology * Neurology * Geriatrics * Gastrointestinal surgery

You may qualify if:

  • 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

You may not qualify if:

  • Skin infection at biopsy site
  • Medical contraindication to obtain a biopsy
  • End of life care
  • Not able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 27841440BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Punch skin biopsy

MeSH Terms

Conditions

Pressure UlcerDermatitis, IrritantDiaper RashIschemia

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDermatitis, ContactDermatitisSkin Diseases, EczematousPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sofie De Schepper

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 26, 2018

Study Start

October 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

November 29, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)