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

NCT03596112 | Completed DMC

• 1 other identifier: Wound size reduction
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• change of wound size

  the wound-size (in cm2) of the target ulcers will differ by 20% over a 12 weeks treatment period between patients with LU and DU using a sterile polyacrylate wound pad with activated carbon cloth treatment and a standard non-adhesive hydrocellular foam dressing with silver treatment

  12 weeks

Study Arms (2)

polyacrylate wound pad

EXPERIMENTAL

Use of cellulose and distinct layers of sodium-polyacrylate pad for wound care; frequency: twice a week

Other: application of a polyacrylate wound pad

hydrocellular foam pad

ACTIVE COMPARATOR

Use of standard foam pad for wound care; frequency: twice a week

Other: Hydrocellular foam

Interventions

application of a polyacrylate wound pad OTHER

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

polyacrylate wound pad

Hydrocellular foam OTHER

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

hydrocellular foam pad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• existing leg ulcer or diabetic foot ulcer
• Light to heavy exudating wounds
• Age over 18 years
• Proficiency in the French language

You may not qualify if:

• Valid informed consent is not or cannot be given

Sponsors & Collaborators

• School of Health Sciences Geneva: lead

Study Sites (1)

Cité Génération Maison de santé

Onex, Canton of Geneva, 1213, Switzerland

Location

Study Officials

• Sebastian E Probst, Prof Dr

  University of Applied Sciences and Arts Western Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 23, 2018
• Study Start: September 1, 2018
• Primary Completion: March 30, 2020
• Study Completion: May 31, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)