Wound Healwound-sizeNCT03596112
The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care
A study testing application of a polyacrylate wound pad and Hydrocellular foam in people with Wound Heal, run by School of Health Sciences Geneva at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- application of a polyacrylate wound pad and Hydrocellular foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2018to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- existing leg ulcer or diabetic foot ulcer
- Light to heavy exudating wounds
- Age over 18 years
- Proficiency in the French language
Who cannot join
- Valid informed consent is not or cannot be given
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cité Génération Maison de santé
Onex, Canton of Geneva, 1213
About this study
Official title: The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care - a Randomized Controlled Trail
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.
Read more
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.
Read the detailed description
Chronic wounds (CW) are poorly healing wounds (Persoon et al., 2004). Chronic leg (LU) and foot ulcers (DU) occur in many adults with vascular disease or diabetes and are attributed to chronic venous insufficiency, arterial disease, prolonged pressure, or neuropathy (Frykberg \& Banks, 2015). Epidemiological data from industrialised countries including the United States of America and Scandinavian countries have shown that the prevalence of leg ulcers in the general population is 1%; while it is 3% in people over 80 years of age (Posnett, Gottrup, Lundgren, \& Saal, 2009). If these findings are applied to the Swiss context then there are an estimated 80'000 to 90'000 VLU sufferers of which 8,000 persons are in the above-80 population segment (above 80 year population in Switzerland: 391,000 ) (Swiss Federal Statistical Office, 2016b). These ulcers last on average 12 to 13 months, recur in up to 60% to 70% of patients, can lead to loss of function and decreased quality of life, and are a significant cause of morbidity (Frykberg \& Banks, 2015).
Predominantly a condition of the elderly, chronic wounds are becoming more prevalent and more difficult to treat and are associated with high treatment costs. The care for such conditions has been an estimated 2% to 3% of all health expenditures in developed countries (Posnett et al., 2009). With a Swiss health budget of 80 billion Swiss francs in 2016, this would translate into an annual cost up to 2.4 billion Swiss francs (Swiss Federal Statistical Office, 2016a).
.The care of chronic wounds has become its own specialty. The therapeutic approach to the management of CW is a multifaceted approach targeting the management of risk factors associated with healing rate and recurrence. Evidence showed the healing rate within a chronic wound is reported to be between 0.1 cm2 and 1cm2 per week independent of the wound-type (Hussain, 2015). The healing rate is mostly associated of the management of bacteria that is amongst other things manifested in wound odour and the used wound dressing and its absorption of wound exudate(Probst, 2015).
Wound odour is not attributed to any one particular source but is thought to be caused by a combination of bacteria including aerobic and anaerobic species, necrotic tissue, poorly vascularized tissue and light levels of exudate (Gethin, Grocott, Probst, \& Clarke, 2014). Malodour due to 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 (Gethin et al., 2014).
Wound exudate is a normal part of the wound healing process in any kind of wound. In general, the quantity of exudate produced decreases as the wound heals and progresses towards wound closure (Probst \& Huljev, 2013). Exudate is particularly noticeable during the inflammatory and proliferative phases of healing because it provides nutrients as an energy source for metabolizing cells and plays a role in regulating the moisture level in the local wound environment (Coleridge-Smith, Lok, \& Ramelet, 2005). This is the case in all chronic wounds. Managing a wound with a high level of exudate is one of the most commonly cited clinical problems not only in LU but also in DU or pressure ulcers (Chamanga, 2015; Probst, 2015; Tickle, 2015). High levels of exudate are challenging in terms of the selection of wound dressing products capable of handling the fluid levels and also the prevention of damage to the surrounding healthy skin (Tickle, 2015). Leakage of exudate through the dressing not only increases the risk of maceration or/ and cross-infection, it may also be distressing for the patient because of soiling of clothing and bedding and possible malodor (Probst, Arber, \& Faithfull, 2013b).Due to unabsorbed heavy exudate, healing is delayed and surrounding skin can be badly damaged due to maceration and excoriation (Chamanga, 2015). Additionally, the psychological effects of coping with a chronic wound on a day to day basis should not be underestimated (Probst, Arber, \& Faithfull, 2013a). For health services, the management of excess exudate presents considerable costs in terms of health professionals' time spent on more frequent visits to change dressings and costs for dressings and associated preventive measures such as skin protection (Probst, 2015). Therefore, the use of effective advanced wound dressings that manage exudate are an important aspect of wound therapy. There are many advanced wound dressings on the market absorbing excessive amounts of exudate. Currently the standard approaches to managing exudate and the presence of high bacteria load are dressings with silver such as the use of hydrocellular foam dressing with silver (non-adhesive or adhesive) or absorbent dressings. However, there is no evidence demonstrating the difference of wound size applying a sterile polyacrylate wound pad with activated carbon cloth treatment in comparison to a standard non -adhesive hydrocellular foam dressing with silver treatment.
This research project is designed to compare two wound dressings in everyday care. Through this comparison the effective amount of wound exudate in the population of LU and DU can be measured. 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, for society at large and the health care system.
- Conditions
- Wound Heal
- Being tested
- application of a polyacrylate wound pad, Hydrocellular foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of a polyacrylate wound padOther
A sterile polyacrylate wound pad with activated carbon cloth treatment will be applied to chronic wounds in an outpatient clinic from a specialist nurse
Hydrocellular foamOther
Active Comparator: hydrocellular foam pad serile hydrocellular standard foam pad will be applied to chronic wounds in an outpatient clinic from a specialist nurse
| Study group | Role | What they receive |
|---|---|---|
| polyacrylate wound pad | Experimental | Use of cellulose and distinct layers of sodium-polyacrylate pad for wound care; frequency: twice a week Receives: Other: application of a polyacrylate wound pad |
| hydrocellular foam pad | Active comparator | Use of standard foam pad for wound care; frequency: twice a week Receives: Other: Hydrocellular foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Sep 2018
- Primary completion30 Mar 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Probst, School of Health Sciences Geneva
- Investigators
- Sebastian E Probst, Prof Dr, Principal investigator, University of Applied Sciences and Arts Western Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596112
- Sponsor's protocol ID
- Wound size reduction
- Acronym
- wound-size
- Status last verified
- Feb 2020
- First submitted
- 10 Jul 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be anonymised
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care - a Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT03596112
- Acronym / sponsor ID
- wound-size / Wound size reduction
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic wounds (CW) are poorly healing wounds (Persoon et al., 2004). Chronic leg (LU) and foot ulcers (DU) occur in many adults with vascular disease or diabetes and are attributed to chronic venous insufficiency, arterial disease, prolonged pressure, or neuropathy (Frykberg \& Banks, 2015). Epidemiological data from industrialised countries including the United States of America and Scandinavian countries have shown that the prevalence of leg ulcers in the general population is 1%; while it is 3% in people over 80 years of age (Posnett, Gottrup, Lundgren, \& Saal, 2009). If these findings are applied to the Swiss context then there are an estimated 80'000 to 90'000 VLU sufferers of which 8,000 persons are in the above-80 population segment (above 80 year population in Switzerland: 391,000 ) (Swiss Federal Statistical Office, 2016b). These ulcers last on average 12 to 13 months, recur in up to 60% to 70% of patients, can lead to loss of function and decreased quality of life, and are a significant cause of morbidity (Frykberg \& Banks, 2015).
Predominantly a condition of the elderly, chronic wounds are becoming more prevalent and more difficult to treat and are associated with high treatment costs. The care for such conditions has been an estimated 2% to 3% of all health expenditures in developed countries (Posnett et al., 2009). With a Swiss health budget of 80 billion Swiss francs in 2016, this would translate into an annual cost up to 2.4 billion Swiss francs (Swiss Federal Statistical Office, 2016a).
.The care of chronic wounds has become its own specialty. The therapeutic approach to the management of CW is a multifaceted approach targeting the management of risk factors associated with healing rate and recurrence. Evidence showed the healing rate within a chronic wound is reported to be between 0.1 cm2 and 1cm2 per week independent of the wound-type (Hussain, 2015). The healing rate is mostly associated of the management of bacteria that is amongst other things manifested in wound odour and the used wound dressing and its absorption of wound exudate(Probst, 2015).
Wound odour is not attributed to any one particular source but is thought to be caused by a combination of bacteria including aerobic and anaerobic species, necrotic tissue, poorly vascularized tissue and light levels of exudate (Gethin, Grocott, Probst, \& Clarke, 2014). Malodour due to 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 (Gethin et al., 2014).
Wound exudate is a normal part of the wound healing process in any kind of wound. In general, the quantity of exudate produced decreases as the wound heals and progresses towards wound closure (Probst \& Huljev, 2013). Exudate is particularly noticeable during the inflammatory and proliferative phases of healing because it provides nutrients as an energy source for metabolizing cells and plays a role in regulating the moisture level in the local wound environment (Coleridge-Smith, Lok, \& Ramelet, 2005). This is the case in all chronic wounds. Managing a wound with a high level of exudate is one of the most commonly cited clinical problems not only in LU but also in DU or pressure ulcers (Chamanga, 2015; Probst, 2015; Tickle, 2015). High levels of exudate are challenging in terms of the selection of wound dressing products capable of handling the fluid levels and also the prevention of damage to the surrounding healthy skin (Tickle, 2015). Leakage of exudate through the dressing not only increases the risk of maceration or/ and cross-infection, it may also be distressing for the patient because of soiling of clothing and bedding and possible malodor (Probst, Arber, \& Faithfull, 2013b).Due to unabsorbed heavy exudate, healing is delayed and surrounding skin can be badly damaged due to maceration and excoriation (Chamanga, 2015). Additionally, the psychological effects of coping with a chronic wound on a day to day basis should not be underestimated (Probst, Arber, \& Faithfull, 2013a). For health services, the management of excess exudate presents considerable costs in terms of health professionals' time spent on more frequent visits to change dressings and costs for dressings and associated preventive measures such as skin protection (Probst, 2015). Therefore, the use of effective advanced wound dressings that manage exudate are an important aspect of wound therapy. There are many advanced wound dressings on the market absorbing excessive amounts of exudate. Currently the standard approaches to managing exudate and the presence of high bacteria load are dressings with silver such as the use of hydrocellular foam dressing with silver (non-adhesive or adhesive) or absorbent dressings. However, there is no evidence demonstrating the difference of wound size applying a sterile polyacrylate wound pad with activated carbon cloth treatment in comparison to a standard non -adhesive hydrocellular foam dressing with silver treatment.
This research project is designed to compare two wound dressings in everyday care. Through this comparison the effective amount of wound exudate in the population of LU and DU can be measured. 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, for society at large and the health care system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyacrylate wound pad | Experimental | Other: application of a polyacrylate wound padUse of cellulose and distinct layers of sodium-polyacrylate pad for wound care; frequency: twice a week |
| hydrocellular foam pad | Active comparator | Other: Hydrocellular foamUse of standard foam pad for wound care; frequency: twice a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- existing leg ulcer or diabetic foot ulcer
- Light to heavy exudating wounds
- Age over 18 years
- Proficiency in the French language
Key exclusion criteria (1 listed)
- Valid informed consent is not or cannot be given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of a polyacrylate wound padA sterile polyacrylate wound pad with activated carbon cloth treatment will be applied to chronic wounds in an outpatient clinic from a specialist nurse | Other | polyacrylate wound pad |
| Hydrocellular foamActive Comparator: hydrocellular foam pad serile hydrocellular standard foam pad will be applied to chronic wounds in an outpatient clinic from a specialist nurse | Other | hydrocellular foam pad |
Primary outcome
change of wound size
Time frame: 12 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No. data will be anonymised
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian E Probst, Prof Dr principal investigator
University of Applied Sciences and Arts Western Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of a polyacrylate wound pad and Hydrocellular foam in people with Wound Heal, run by School of Health Sciences Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of wound size (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.