Condition category
Injury, Occupational Diseases, Poisoning
Date applied
21/07/2017
Date assigned
01/08/2017
Last edited
26/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic ulcers are defined as ulcers that do not heal in six to nine weeks.This type of ulcer is a big health problem all over the world, affecting the life of patients and the health care system. Wound dressings based on a dense fibrillary network (fibers) made of biosynthetic cellulose (BC), such as eiratex® have been proposed to be a good alternative to the different types of dressings that are currently used to treat this type of ulcers. This is due to their similarity to collagen in skin (the protein in the skin that gives skin strength and elasticity). However, traditional BC has been problematic on infected ulcers since fluids as exudate can be trapped under the dressing. The aim of this study is to examine if a wound dressing based on eiratex® can facilitate the healing of the wound and overcome the problems related to the use of the traditional BC.

Who can participate?
Adults aged 62 to 85 who have a chronic lower limb wound (ulcer) that has not healed after six weeks.

What does the study involve?
Participants are treated with the eiratex®-based wound dressing. The dressing is applied on the ulcers after surgical removal of the damaged area or tissue, when applicable. The wounds are examined every second day by the attending physician during the first week, and then once per week until final healing. When the wound started to heal, the dressing should be found to adhere to the wound, typically within two days from the start of treatment. In case of lack of improvement of the wound healing, a new debridement was carried out and a new eiratex® membrane was applied to the wound. Once the dressing adhered it is not removed from the wound until it spontaneously fell off. An examination by the attending physician is then performed to assess wound healing.

What are the possible benefits and risks of participating?
There are no benefits or risks with participating.

Where is the study run from?
Ewecare AB (Sweden)

When is the study starting and how long is it expected to run for?
January 2016 to May 2017

Who is funding the study?
S2Medical AB (Sweden)

Who is the main contact?
Mr Tobias Sivler
tobias.sivler@s2m.se

Trial website

Contact information

Type

Public

Primary contact

Mr Tobias Sivler

ORCID ID

Contact details

Linköping University
Linköping
581 83
Sweden
+46 73 800 88 08
tobias.sivler@s2m.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1101

Study information

Scientific title

A clinical trial on patients with non-healing ulcers treated with a modified version of a biosynthetic cellulose named eiratex: Effects on the healing rate, healing time and treatment costs compared to a saline-soaked gauze and other wound dressings.

Acronym

Study hypothesis

Wound dressing based on eiratex® could facilitate the healing of the wound and overcome the problems related to the use of the traditional BC.

Ethics approval

As the the product is registed in registered in Sweden as medical device and is CE-marked, according to Swedish law, ethical approval is not necessary for the study. The study itself was not an experimental procedure.The patients were treated and their follow-up data collected only after informed consent. All patient information was blinded so that no information can be back traced to individual patients.

Study design

Observational cross-sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patients with chronic lower-extremity venous ulcers or traumatic ulcers were object of this trial

Intervention

The eiratex® dressing was applied on the wound after surgical debridement, where applicable. The wounds are examined every second day by the attending physician during the first week, and then once per week until final healing.

When the wound started to heal, the dressing was found to adhere to the wound, typically within two days from initiation of treatment. In case of lack of improvement of the wound healing, a new debridement was carried out and a new eiratex® membrane was applied to the wound. In three patients clinical signs of infection were seen. Once the dressing adhered it was not removed from the wound until it spontaneously fell off. An examination by the attending physician was then performed to assess wound healing.

At each treatment visit, information regarding adverse events, medications and other aspects of care since the last visit was acquired. All wounds were photographed before treatment and at each follow-up visit after treatment.

Intervention type

Phase

Drug names

Primary outcome measures

Healing time is measured by visual examination from the medical doctor. At each treatment visit, information regarding adverse events, medications and other aspects of care since the last visit was acquired.

Secondary outcome measures

1. Frequency of dressing changes are measured by counting the total number of dressings used during the treatment for each patient, divided by the healing time (in weeks)
2. Number of dressings used are measured by the doctor for each patient. The number of dressings used is related to the number needed to heal the wound

Overall trial start date

01/01/2016

Overall trial end date

30/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic lower limb wounds that were not healed after 6 weeks from the initial injury
2. Treated with eiratex® for the whole treatment
3. Non-infected and infected ulcers
4. Aged from 62 to 85 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8

Participant exclusion criteria

1. Patients with exposure of bone, muscle, ligaments, or tendons
2. Patient with mental disorders were excluded to guarantee a conscious agreement to the participation in this study

Recruitment start date

01/02/2016

Recruitment end date

01/03/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Ewecare AB
Hejdegatan 68
Linköping
58243
Sweden

Sponsor information

Organisation

Ewecare AB

Sponsor details

Hejdegatan 68
Linköping
58243
Sweden

Sponsor type

Other

Website

Funders

Funder type

Industry

Funder name

S2Medical AB

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal is expected in around 10 months after the end of the trial.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Petter Silver, petter.sivler@s2m.se. Data about the outcomes of the study are stored as excel files and will only be shared upon request.

Intention to publish date

30/03/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes