Necrotizing Soft Tissue InfectionNPWTvsGPANCT02314468
Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation
A study testing Negative pressure wound therapy and Glycerol Preserved Allografts (GPA) in people with Necrotizing Soft Tissue Infection, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Introduction Necrotising soft tissue infections (NSTI) incorporate a spectrum of pathologies, all characterized by an infectious state, typically arising after a penetrating trauma or a surgical procedure and an expeditious spreading of necrosis throughout the soft tissues of the body. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Necrotizing Soft Tissue Infection
- What is being tested?
- Negative pressure wound therapy and Glycerol Preserved Allografts (GPA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2013to Oct 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Necrotising soft tissue infection
Who cannot join
- None specific
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation in Necrotising Soft Tissue Infections
Introduction Necrotising soft tissue infections (NSTI) incorporate a spectrum of pathologies, all characterized by an infectious state, typically arising after a penetrating trauma or a surgical procedure and an expeditious spreading of necrosis throughout the soft tissues of the body. It is a rare, life-threatening and devastating infection defined by a necrosis of fascia, subcutaneous tissues and skin. Aggressive surgical debridement to remove all necrotic tissue and define the extent of the disease is still the mainstay of correct treatment of NSTI.
Both negative pressure wound therapy (NPWT) and the application of allograft skin to debrided areas, are documented options for wound bed preparation which are standard in the university hospital of Gent.
Read more
NPWT is a technique for wound bed preparation involving the controlled application of sub-atmospheric pressure to the local wound environment, using a sealed wound dressing connected to a vacuum pump. Mechanisms of action attributed to NPWT include an increase in blood flow, promotion of angiogenesis, reduction in wound surface area, positive modulation of the inhibitory contents of wound fluid, induction of cell proliferation, reduction of edema, and bacterial clearance.
Allograft skin or cadaveric skin possesses many of the ideal properties of biologic dressings, and plays a major role in the surgical management of extensive wounds when autologous tissue may not be immediately available. It reduces evaporative water loss and the drainage of protein-rich fluids, prevents wound desiccation, and suppresses microbial proliferation. Wound pain is lessened and the allograft restores a physiologic barrier at the wound surface. Enhancing revascularization, and thereby creating a viable wound bed before final reconstruction, is perceived as one of the most important features of allografting.
Read the detailed description
Study objectives This study will compare negative pressure wound therapy versus cadaveric skin as treatment options for wound bed preparation in wounds resulting from necrotising soft tissue infection.
Methodology One arm includes a NPWT system that is used in conjunction with gauze or foam dressings. Dressing changes normally will be carried out twice a week unless otherwise indicated by the wound condition, the patients clinical presentation or a seal broken beyond repair. NPWT wound bed preparation will be ended when two experienced plastic surgeons consider the wound bed suitable for autografting. (Endpoint) The second arm includes application of cadaveric skin. The allografts normally will be changed every seven to ten days or earlier depending on adhesion of the allograft to the wound bed. In practice, the ability of the allograft to adhere to the wound bed has a diagnostic value, referred to as a 'take-test'. If the allograft does not adhere, one must consider an infection or non-viable wound surface. If the allograft adheres to the wound bed and adequate granulation tissue is suspected underneath, then the wound bed is suitable for autografting. (Endpoint)
- Conditions
- Necrotizing Soft Tissue Infection
- Being tested
- Negative pressure wound therapy, Glycerol Preserved Allografts (GPA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapyProcedure or surgery
NPWT changed twice a week.
Glycerol Preserved Allografts (GPA)Procedure or surgery
GPA changed every 7 to 10 days.
| Study group | Role | What they receive |
|---|---|---|
| negative pressure wound therapy (NPWT) | Active comparator | negative pressure wound therapy (NPWT) Receives: Procedure: Negative pressure wound therapy |
| Glycerol Preserved Allografts (GPA) | Active comparator | Glycerol Preserved Allografts (GPA) Receives: Procedure: Glycerol Preserved Allografts (GPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of wound bed preparation until autografting.
WHAT software, clinical assessment by plastic surgeon, Laser Doppler Imaging scan.
Measured: After 3 days
Secondary outcomes (3)
Pain assessment until autografting.
Numerical pain scale.
Measured: After 3 days
Ease of use until autografting.
Numerical scale for ease of use.
Measured: After 3 days
Cost utility until autografting.
Cost of material.
Measured: After 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2016
- Study completionOct 2016
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Soft Tissue InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stan Monstrey, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314468
- Sponsor's protocol ID
- 2013/724
- Acronym
- NPWTvsGPA
- Status last verified
- Feb 2023
- First submitted
- 30 Sep 2013
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Negative Pressure Wound Therapy and Allogeneic Human Skin Grafts for Wound Bed Preparation in Necrotising Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT02314468
- Acronym / sponsor ID
- NPWTvsGPA / 2013/724
- Conditions
- Necrotizing Soft Tissue Infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Dec 2014 (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.
Introduction Necrotising soft tissue infections (NSTI) incorporate a spectrum of pathologies, all characterized by an infectious state, typically arising after a penetrating trauma or a surgical procedure and an expeditious spreading of necrosis throughout the soft tissues of the body. It is a rare, life-threatening and devastating infection defined by a necrosis of fascia, subcutaneous tissues and skin. Aggressive surgical debridement to remove all necrotic tissue and define the extent of the disease is still the mainstay of correct treatment of NSTI.
Both negative pressure wound therapy (NPWT) and the application of allograft skin to debrided areas, are documented options for wound bed preparation which are standard in the university hospital of Gent.
NPWT is a technique for wound bed preparation involving the controlled application of sub-atmospheric pressure to the local wound environment, using a sealed wound dressing connected to a vacuum pump. Mechanisms of action attributed to NPWT include an increase in blood flow, promotion of angiogenesis, reduction in wound surface area, positive modulation of the inhibitory contents of wound fluid, induction of cell proliferation, reduction of edema, and bacterial clearance.
Allograft skin or cadaveric skin possesses many of the ideal properties of biologic dressings, and plays a major role in the surgical management of extensive wounds when autologous tissue may not be immediately available. It reduces evaporative water loss and the drainage of protein-rich fluids, prevents wound desiccation, and suppresses microbial proliferation. Wound pain is lessened and the allograft restores a physiologic barrier at the wound surface. Enhancing revascularization, and thereby creating a viable wound bed before final reconstruction, is perceived as one of the most important features of allografting.
Detailed description
Study objectives This study will compare negative pressure wound therapy versus cadaveric skin as treatment options for wound bed preparation in wounds resulting from necrotising soft tissue infection.
Methodology One arm includes a NPWT system that is used in conjunction with gauze or foam dressings. Dressing changes normally will be carried out twice a week unless otherwise indicated by the wound condition, the patients clinical presentation or a seal broken beyond repair. NPWT wound bed preparation will be ended when two experienced plastic surgeons consider the wound bed suitable for autografting. (Endpoint) The second arm includes application of cadaveric skin. The allografts normally will be changed every seven to ten days or earlier depending on adhesion of the allograft to the wound bed. In practice, the ability of the allograft to adhere to the wound bed has a diagnostic value, referred to as a 'take-test'. If the allograft does not adhere, one must consider an infection or non-viable wound surface. If the allograft adheres to the wound bed and adequate granulation tissue is suspected underneath, then the wound bed is suitable for autografting. (Endpoint)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| negative pressure wound therapy (NPWT) | Active comparator | Procedure: Negative pressure wound therapynegative pressure wound therapy (NPWT) |
| Glycerol Preserved Allografts (GPA) | Active comparator | Procedure: Glycerol Preserved Allografts (GPA)Glycerol Preserved Allografts (GPA) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Necrotising soft tissue infection
Key exclusion criteria (1 listed)
- None specific
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 |
|---|---|---|
| Negative pressure wound therapyNPWT changed twice a week. | Procedure or surgery | negative pressure wound therapy (NPWT) |
| Glycerol Preserved Allografts (GPA)GPA changed every 7 to 10 days. | Procedure or surgery | Glycerol Preserved Allografts (GPA) |
Primary outcome
Quality of wound bed preparation until autografting.
Time frame: After 3 days
WHAT software, clinical assessment by plastic surgeon, Laser Doppler Imaging scan.
3 secondary outcomes
Pain assessment until autografting.
Time frame: After 3 days
Ease of use until autografting.
Time frame: After 3 days
Cost utility until autografting.
Time frame: After 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- website hospitalLink provided by the sponsor.
Related trials for Necrotizing Soft Tissue Infection
RecruitingObservational study
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
Necrotizing Fascitis
Recruiting
Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infections
Recruiting
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Necrotizing Fascitis, Necrotizing Soft Tissue Infection
RecruitingPhase 4
Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
Necrotizing Soft Tissue Infection
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
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 study testing Negative pressure wound therapy and Glycerol Preserved Allografts (GPA) in people with Necrotizing Soft Tissue Infection, 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 1 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: withdrawn, as of the sponsor's last update on 10 Feb 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quality of wound bed preparation until autografting. (time frame: After 3 days). 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 10 Feb 2023.