Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03685929

Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

Pressure Ulcer Clinical Trial

Official title:
Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03685929
Study type Observational
Source University Ghent
Contact
Status Completed
Phase
Start date October 1, 2018
Completion date December 31, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT03351049 - An RCT on Support Surfaces for Pressure Ulcer Prevention N/A
Completed NCT05112068 - Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
Completed NCT05575869 - Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students N/A
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Completed NCT04540822 - Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care N/A
Terminated NCT05234632 - Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds N/A
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01438541 - A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration Phase 4
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Completed NCT04251897 - Novel Support Surface to Alleviate Pressure Ulcer N/A
Completed NCT03391310 - Use of Honey for Pressure Ulcers in Critically Ill Children N/A
Recruiting NCT04559165 - Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore N/A
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Not yet recruiting NCT06421454 - Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers N/A
Terminated NCT05547191 - Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement N/A
Completed NCT05458050 - An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers N/A
Active, not recruiting NCT03048357 - Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury. N/A
Completed NCT06025370 - Pressures During Prone Positions in Healthy Volunteers N/A
Recruiting NCT05033470 - A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers N/A