The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care

NCT03596112 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2020-07-21

No results posted yet for this study

Summary

Chronic wounds (CW) such as leg or foot ulcers are slow healing wounds. They have a high recurrence rate and are associated with pain, infection, smell and exudate. The signs and symptoms of a chronic wounds are not only a burden on those who are affected by it but also on the health care system and society in general. With a prevalence of 1% in the general population, the prevalence rises to 3% in the over 80-age group. Current therapeutic approaches are multifaceted and focus on improving wound healing and preventing recurrences. Advanced wound dressings, especially super absorbent dressings are an important part of the wound care. Heavy wound exudate, if unabsorbed, may damage surrounding healthy skin and thus delay wound healing and contribute to maceration and excoriation regimen as CW may deliver excessive amounts of exudate followed by maldour. Maldodourous wounds can have a profoundly negative impact on the quality of life of the patient and of their carers causing feelings of guilt repulsion and leading to social isolation and depression. Therefore, it is important to use effective advanced wound dressings that are capable of managing wound exudate and with that promote wound healing. Currently the standard approches to managing exudate and wound odour are the use of hydrocellular foam dressing with silver or absorbent dressings like of a sterile polyacrylate wound pad with activated carbon cloth treatment. However, there is no evidence demonstrating whether there is adifference in wound size as an indicator of wound healing when comparing the application of a sterile polyacrylate wound pad with activated carbon clothtreatment to a standard non-adhesive hydrocellular foam dressing with silver treatment in a randomised controlled trail.

A randomized controlled trail with 90 participants in one wound care outpatient clinic is proposed.

Data will be analysed using SPSS version 23. Univariate and bivariate analysis will be conducted according to the data level and distribution.

This research project is designed to compare two wound dressings in everyday care. Since the cost of leg ulcers to individuals, the economy, and society is high, the evaluation of wound care dressings that leads to a reduction of wound size and promote wound healing are important for the individuals affected, their families, society at large and the health care system.

Conditions

  • Wound Heal

Interventions

OTHER

application of a polyacrylate wound pad

A sterile polyacrylate wound pad with activated carbon cloth treatment will be applied to chronic wounds in an outpatient clinic from a specialist nurse

OTHER

Hydrocellular foam

Active Comparator: hydrocellular foam pad serile hydrocellular standard foam pad will be applied to chronic wounds in an outpatient clinic from a specialist nurse

Sponsors & Collaborators

  • School of Health Sciences Geneva

    lead OTHER

Principal Investigators

  • Sebastian E Probst, Prof Dr · University of Applied Sciences and Arts Western Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2020-03-30
Completion
2020-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596112 on ClinicalTrials.gov