WoundsPhase 4NCT01107821
Negative Pressure Wound Therapy With the Engenex™-Pump and Bio-Dome™ Dressing, an Evaluation
A Phase 4 study testing Engenex™ pump and Bio-Dome™ Wound Dressing in people with Wounds, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Negative pressure wound therapy (NPWT) has become a powerful tool in wound bed preparation of complex wounds and is routinely used in various disciplines, including general surgery and plastic surgery. NPWT involves the creation of a controlled subatmospheric pressure in the wound bed. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Wounds
- What is being tested?
- Engenex™ pump and Bio-Dome™ Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2010to Sep 2010
- Phase
- Phase 4
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Wounds will be assessed by plastic surgeons to evaluate the indication for wound bed preparation. If suitable for NPWT, they will be treated with Engenex® NPWT-system.
- Suitable wounds include:
- Pressure sores grade III and IV
- Traumatic wounds with considerable soft tissue loss
- Wounds after necrotizing fasciitis
- Abdominal wounds
Who cannot join
- Impossibility to adhere the polyurethane film to healthy surrounding skin
- Malignancy in the wound
- Untreated osteomyelitis
- Non-enteric and unexplored fistula
- Undebrided wounds with necrotic tissue
- Exposed organs and blood vessels (Always protect vessels, organs, and nerves by covering them with natural tissues or several layers of fine-meshed, non-adherent synthetic material that form a complete barrier.)
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- Increased risk of bleeding
- Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient inappropriate for this trial
- The plastic surgeon decides that NPWT therapy should be stopped for other reasons than failure of the NPWT therapy
- Less than two weeks of NPWT
Trial locations and contacts
1 site in 1 country.
About this study
Negative pressure wound therapy (NPWT) has become a powerful tool in wound bed preparation of complex wounds and is routinely used in various disciplines, including general surgery and plastic surgery.
NPWT involves the creation of a controlled subatmospheric pressure in the wound bed. The vacuum is generated by a pump and is distributed over the wound bed by a dressing (mostly a foam or gauze sponge). The therapy has several positive effects on the wound bed, such as improved local blood circulation, stimulation of granulation tissue formation and controlled evacuation of wound exudates. Standard negative pressure applied mostly varies between -120 mmHg and -130 mmHg.A new way of applying NPWT is the Engenex™ system using the Bio-Dome™ Wound Dressing, a specially engineered structure that forms a defined space above the surface of the wound. This space will maintain its size and integrity in the presence of negative pressure and wound fluids and thus effectively imposes strain on the underlying tissue. The material properties of the dressing permit moist wound healing while encouraging efficient removal of exudates. The contact material will not absorb fluid. It has been clinically shown that the Bio-Dome™ Wound Dressing is effective at growing granular tissue in the base of a wound at a safe low negative pressure of -75 mmHg, possibly reducing dressing ingrowth into the wound bed to a minimum.
Read more
Our intention is to evaluate NPWT by means of the Engenex™ pump and Bio- Dome™ Wound Dressing in 15 patients. Patients with large soft tissue defects will be examined by a plastic surgeon and if suitable for NPWT they will be treated with the Engenex™ NPWT system.
Before starting NPWT wounds will be evaluated and measured (length, width, depth, volume) if possible. Digital photos will be made and wound swabs will be taken for microbiological examination.Dressing changes will be performed twice weekly, on Monday and Thursday or on Tuesday and Friday. At each dressing change a wound will be re-evaluated and measured.
Other parameters to be noted will be, amongst others: pain, comfort, ease of use,material used, time needed for dressing change, etc.
The NPWT treatment will be carried on for maximum three weeks. During this period plastic surgeons will evaluate whether the wound is ready for surgical closure or not.
If surgical closure after 3 weeks is not yet an option possibility exists that NPWT will be continued.
Every wound will be followed up until complete wound healing after surgical closure.
All patients data will be recorded, secured, evaluated and analysed for both medical parameters and health economic parameters.
- Conditions
- Wounds
- Being tested
- Engenex™ pump and Bio-Dome™ Wound Dressing
- Keywords
- Pressure sores grade III and IV, Traumatic wounds with considerable soft tissue loss, Wounds after necrotizing fasciitis, Abdominal wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engenex™ pump and Bio-Dome™ Wound DressingDevice
Engenex™ pump and Bio-Dome™ Wound Dressing is used.
| Study group | Role | What they receive |
|---|---|---|
| Engenex™-pump | Experimental | Negative Pressure Wound Therapy with the Engenex™-pump and Bio-Dome™ Dressing Receives: Device: Engenex™ pump and Bio-Dome™ Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and efficacy of NPWT with Engenex®
Following parameters are assessed:
- Adverse Events
- Wound size/volume and clinical aspects (odour, masceration): clinical evaluation, digital photography
- Degree of pain, measured by a numeric scale and the use of analgesics at each dressing intervention.
- Control of Bioburden: Rate of critical colonization and/or infection •% of patients with clinical infection requiring systemic antimicrobial therapy
- Monitoring of subject's comfort with the dressing in situ, evaluated by subject.
- Ease of use and dressing application and dressing removal, evaluated by health care personnel
Measured: at least 2 weeks
Secondary outcomes (1)
To provide instructions for optimal use of Engenex®
Measured: at least 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTec Inc.
- Responsible party
- Sponsor
- Investigators
- Stan Monstrey, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107821
- Sponsor's protocol ID
- 2009/597
- Status last verified
- Jan 2023
- First submitted
- 8 Apr 2010
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy With the Engenex™-Pump and Bio-Dome™ Dressing, an Evaluation
- ClinicalTrials.gov ID
- NCT01107821
- Acronym / sponsor ID
- 2009/597
- Conditions
- Wounds
- Keywords
- Pressure sores grade III and IV, Traumatic wounds with considerable soft tissue loss, Wounds after necrotizing fasciitis, Abdominal wounds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- ConvaTec Inc.
- Study start
- Feb 2010 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Apr 2010 (estimated)
- 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.
Negative pressure wound therapy (NPWT) has become a powerful tool in wound bed preparation of complex wounds and is routinely used in various disciplines, including general surgery and plastic surgery.
NPWT involves the creation of a controlled subatmospheric pressure in the wound bed. The vacuum is generated by a pump and is distributed over the wound bed by a dressing (mostly a foam or gauze sponge). The therapy has several positive effects on the wound bed, such as improved local blood circulation, stimulation of granulation tissue formation and controlled evacuation of wound exudates. Standard negative pressure applied mostly varies between -120 mmHg and -130 mmHg.A new way of applying NPWT is the Engenex™ system using the Bio-Dome™ Wound Dressing, a specially engineered structure that forms a defined space above the surface of the wound. This space will maintain its size and integrity in the presence of negative pressure and wound fluids and thus effectively imposes strain on the underlying tissue. The material properties of the dressing permit moist wound healing while encouraging efficient removal of exudates. The contact material will not absorb fluid. It has been clinically shown that the Bio-Dome™ Wound Dressing is effective at growing granular tissue in the base of a wound at a safe low negative pressure of -75 mmHg, possibly reducing dressing ingrowth into the wound bed to a minimum.
Our intention is to evaluate NPWT by means of the Engenex™ pump and Bio- Dome™ Wound Dressing in 15 patients. Patients with large soft tissue defects will be examined by a plastic surgeon and if suitable for NPWT they will be treated with the Engenex™ NPWT system.
Before starting NPWT wounds will be evaluated and measured (length, width, depth, volume) if possible. Digital photos will be made and wound swabs will be taken for microbiological examination.Dressing changes will be performed twice weekly, on Monday and Thursday or on Tuesday and Friday. At each dressing change a wound will be re-evaluated and measured.
Other parameters to be noted will be, amongst others: pain, comfort, ease of use,material used, time needed for dressing change, etc.
The NPWT treatment will be carried on for maximum three weeks. During this period plastic surgeons will evaluate whether the wound is ready for surgical closure or not.
If surgical closure after 3 weeks is not yet an option possibility exists that NPWT will be continued.
Every wound will be followed up until complete wound healing after surgical closure.
All patients data will be recorded, secured, evaluated and analysed for both medical parameters and health economic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Engenex™-pump | Experimental | Device: Engenex™ pump and Bio-Dome™ Wound DressingNegative Pressure Wound Therapy with the Engenex™-pump and Bio-Dome™ Dressing |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Wounds will be assessed by plastic surgeons to evaluate the indication for wound bed preparation. If suitable for NPWT, they will be treated with Engenex® NPWT-system.
- Suitable wounds include:
Key exclusion criteria (10 listed)
- Impossibility to adhere the polyurethane film to healthy surrounding skin
- Malignancy in the wound
- Untreated osteomyelitis
- Non-enteric and unexplored fistula
- Undebrided wounds with necrotic tissue
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 |
|---|---|---|
| Engenex™ pump and Bio-Dome™ Wound DressingEngenex™ pump and Bio-Dome™ Wound Dressing is used. | Device | Engenex™-pump |
Primary outcome
To evaluate safety and efficacy of NPWT with Engenex®
Time frame: at least 2 weeks
Following parameters are assessed: * Adverse Events * Wound size/volume and clinical aspects (odour, masceration): clinical evaluation, digital photography * Degree of pain, measured by a numeric scale and the use of analgesics at each dressing intervention. * Control of Bioburden: Rate of critical colonization and/or infection •% of patients with clinical infection requiring systemic antimicrobial therapy * Monitoring of subject's comfort with the dressing in situ, evaluated by subject. * Ease of use and dressing application and dressing removal, evaluated by health care personnel
1 secondary outcome
To provide instructions for optimal use of Engenex®
Time frame: at least 2 weeks
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 4 Jan 2023.
- website University Hospital GhentLink provided by the sponsor.
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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.
Stan Monstrey, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Engenex™ pump and Bio-Dome™ Wound Dressing in people with Wounds, run by University Hospital, Ghent at 1 site in Belgium.
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 6 inclusion and 10 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 4 Jan 2023. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate safety and efficacy of NPWT with Engenex® (time frame: at least 2 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 4 Jan 2023.