Wound ComplicationIMPARTNCT03948412
Negative Pressure Wound Therapy (PREVENA) Versus Standard Dressings for Incision Management After Renal Transplant
A study testing Closed Incision Negative Pressure Wound Therapy (Prevena) in people with Wound Complication, run by Royal North Shore Hospital at 1 site in Australia.
Trial summary
This study is a multicentre, partially-blinded randomised controlled trial, with site stratified block randomisation and partial blinding of outcome assessments. Patients undergoing a renal transplant will be allocated to one of two treatment arms, where either a Prevena device of appropriate size or standard dressing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Complication
- What is being tested?
- Closed Incision Negative Pressure Wound Therapy (Prevena)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteAustralia
- Study dates
- 10 May 2019to Sep 2021
- 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
- The participant:
- is an adult ≥ 18 years old, regardless of comorbidities or BMI
- is able to provide their own informed consent
- will undergo open renal transplant surgery, including those who undergo dual renal transplant or simultaneous pancreas transplant.
- will require a surgical incision(s) likely to be able to be covered completely by one or more Prevena Incision Management Systems.
- is willing and able to return for the required follow up assessments.
- if concurrently enrolled in a clinical trial it must not impact on patient health or the surgical incision site and the study must be documented
Who cannot join
- The participant:
- has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives.
- Is not suitable for closure of the surgical wound, and as such the wound must be left open or an open NPWT device is required.
- Is not willing to comply with the study procedures.
- Has an unforseen intraoperative event mandating additional management including a planned re-exploration.
- Has obvious intraoperative contamination of the surgical site.
- Has a wound with suspected ischaemia in the incision area, or inadequate haemostasis. 7. Requires drains that cannot be covered by the Prevena dressing.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal North Shore Hospital
Sydney, New South Wales, 2065
Linda Pallot, +61294631767, Linda.Pallot@health.nsw.gov.au
About this study
Official title: Incision Management With Prevena After Renal Transplant (IMPART) Trial: Negative Pressure Wound Therapy Versus Standard Dressings for Incision Management After Renal Transplant: a Multicentre, Partially-blinded Randomised Controlled Trial
This study is a multicentre, partially-blinded randomised controlled trial, with site stratified block randomisation and partial blinding of outcome assessments. Patients undergoing a renal transplant will be allocated to one of two treatment arms, where either a Prevena device of appropriate size or standard dressing is applied to the closed incision. In the case that a patient requires bilateral incisions, both incisions will be allocated to the same treatment arm and counted as a single incision.
Primary:
The primary objective of this study is to determine if the Prevena Incision Management System reduces wound complications at the surgical site following renal transplant, when compared to standard dressings. Secondary: Secondary objectives of this study include identification of risk factors for wound complications at the surgical site, as well as re-operation, prolonged hospital stay, allograft survival, delayed graft function. This study will also assess pain, scar healing and quality of life in each treatment arm, and aim to complete a cost-benefit analysis of the Prevena device in renal transplantation.
- Conditions
- Wound Complication
- Being tested
- Closed Incision Negative Pressure Wound Therapy (Prevena), Control - Standard Dressings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Incision Negative Pressure Wound Therapy (Prevena)Device
Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation.
Control - Standard DressingsOther
Standard wound dressings applied to closed wound at completion of operation.
| Study group | Role | What they receive |
|---|---|---|
| Closed Incision Negative Pressure Wound Therapy (Prevena) | Experimental | Patients are randomised intra-operatively to either Prevena or standard dressings as long as inclusion criteria are met, and no exclusion criteria met. This is left in-situ for 7 days, unless clinically indicated. Receives: Device: Closed Incision Negative Pressure Wound Therapy (Prevena) |
| Standard Dressings | Active comparator | Patients are randomised intra-operatively to either Prevena or standard dressings as long as inclusion criteria are met, and no exclusion criteria met. Standard care wound dressings are applied for patients in this arm. These are changed as clinically appropriate whilst in hospital. Receives: Other: Control - Standard Dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Complications
Any wound infection, wound dehiscence, wound haematoma, wound collection or re-operation due to the above following renal transplantation.
Measured: 0-90 days
Secondary outcomes (8)
Length of hospital stay
Comparison of length of hospital stay between the two groups
Measured: 0-90 days
Graft function (creatinine)
Comparison of markers of graft function (creatinine) between the two groups
Measured: 0-90 days
Delayed graft function
Number of patients requiring ongoing dialysis in each group.
Measured: 0-90 days
Pain score (numeric rating scale)
Comparison of patient reported post-operative wound pain scale between groups utilising a generic numeric rating scale (NRS) for pain.
A numeric rating scale is a way a patient can report pain from 0-10, 0 being no pain, 10 being extreme pain. Minimum score is 0, maximum score is 10. It is better to have less pain, therefore 0 is the best score possible.
Measured: 0-90 days
Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)
Comparison of observer and patient reported scarring utilising the POSAS (The Patient and Observer Scar Assessment Scale: POSAS).
The observer questions are listed below and are each scored from 1 to 10, 1 being normal skin, 10 being worst scar imaginable.
- Vascularity
- Pigmentation
- Thickness
- Relief
- Pliability
- Surface area
- Overall opinon of scar The patient scale questions are listed below and are each scored from 1 to 10, 1 being normal skin, 10 being the worst scar imaginable.
- Has the scar been painful the past few weeks? 2. Has the scar been itching the past few weeks? 3. Skin Colour 4. Skin stiffness 5. Skin Thickness 6. Scar irregularity 7. Overall opinion of scar The total score for patient and observer subscales is out of 70 each, for a combined total of 140 (both subscales added together). The minimum possible score is 14 and the maximum score is 140.
Measured: 0-90 days
Quality of Life (EQ-5D-5L score)
Comparison of quality of life scores reported by patients in each group using the EQ-5D-5L quality of life scale.
The scale is split into 5 subscales;
- mobility
- self-care
- usual activities
- pain/discomfort
- anxiety/depression. Each subscale is ranked from 1 to 5, 1 being nil pain/quality of life disturbance, 5 being extreme pain/quality of life disturbance. The subscales are reported separately and are not combined.
The patient also completes an overall health assessment from 0-100, 0 being the worst health imaginable, 100 being the best health imaginable. This is also reported and analysed separately.
Measured: 0-90days
Graft function (estimated glomerular filtration rate)
Comparison of markers of graft function (creatinine) between the two groups
Measured: 0-90days
ASEPSIS wound score
Wound scoring by a wound assessor.
Scored:
0-5 for serous discharge and erythema (each), 0 being nil, 5 being significant. 0-10 for purulent exudate and separation of deep tissues (each), 0 being nil, 10 being significant.
Isolation of bacteria on wound swap, 0 for no bacterial, 10 for bacterial growth.
Further scores of 10 (for antibiotic usage), 5 (for drainage of pus under local anaesthesia), 10 (for debridement under general anaesthesia) and 5 (for prolonged inpatient stay >14 days).
All scores are added together for a total of 70, 0 being the minimum possible (best) score and 70 being the maximum possible (worst) score.
Measured: 0-90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start10 May 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Herlihy, Royal North Shore Hospital
- Investigators
- Vikram Puttaswamy, MBBS, Principal investigator, Vascular Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948412
- Sponsor's protocol ID
- RNSH-VASC-2019-1
- Acronym
- IMPART
- Status last verified
- May 2019
- First submitted
- 5 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incision Management With Prevena After Renal Transplant (IMPART) Trial: Negative Pressure Wound Therapy Versus Standard Dressings for Incision Management After Renal Transplant: a Multicentre, Partially-blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03948412
- Acronym / sponsor ID
- IMPART / RNSH-VASC-2019-1
- Conditions
- Wound Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 10 May 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 May 2019 (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.
This study is a multicentre, partially-blinded randomised controlled trial, with site stratified block randomisation and partial blinding of outcome assessments. Patients undergoing a renal transplant will be allocated to one of two treatment arms, where either a Prevena device of appropriate size or standard dressing is applied to the closed incision. In the case that a patient requires bilateral incisions, both incisions will be allocated to the same treatment arm and counted as a single incision.
Primary:
The primary objective of this study is to determine if the Prevena Incision Management System reduces wound complications at the surgical site following renal transplant, when compared to standard dressings. Secondary: Secondary objectives of this study include identification of risk factors for wound complications at the surgical site, as well as re-operation, prolonged hospital stay, allograft survival, delayed graft function. This study will also assess pain, scar healing and quality of life in each treatment arm, and aim to complete a cost-benefit analysis of the Prevena device in renal transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Incision Negative Pressure Wound Therapy (Prevena) | Experimental | Device: Closed Incision Negative Pressure Wound Therapy (Prevena)Patients are randomised intra-operatively to either Prevena or standard dressings as long as inclusion criteria are met, and no exclusion criteria met. This is left in-situ for 7 days, unless clinically indicated. |
| Standard Dressings | Active comparator | Other: Control - Standard DressingsPatients are randomised intra-operatively to either Prevena or standard dressings as long as inclusion criteria are met, and no exclusion criteria met. Standard care wound dressings are applied for patients in this arm. These are changed as clinically appropriate whilst in hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- is an adult ≥ 18 years old, regardless of comorbidities or BMI
- is able to provide their own informed consent
- will undergo open renal transplant surgery, including those who undergo dual renal transplant or simultaneous pancreas transplant.
- will require a surgical incision(s) likely to be able to be covered completely by one or more Prevena Incision Management Systems.
- is willing and able to return for the required follow up assessments.
Key exclusion criteria (7 listed)
- has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives.
- Is not suitable for closure of the surgical wound, and as such the wound must be left open or an open NPWT device is required.
- Is not willing to comply with the study procedures.
- Has an unforseen intraoperative event mandating additional management including a planned re-exploration.
- Has obvious intraoperative contamination of the surgical site.
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 |
|---|---|---|
| Closed Incision Negative Pressure Wound Therapy (Prevena)Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation. | Device | Closed Incision Negative Pressure Wound Therapy (Prevena) |
| Control - Standard DressingsStandard wound dressings applied to closed wound at completion of operation. | Other | Standard Dressings |
Primary outcome
Wound Complications
Time frame: 0-90 days
Any wound infection, wound dehiscence, wound haematoma, wound collection or re-operation due to the above following renal transplantation.
8 secondary outcomes
Length of hospital stay
Time frame: 0-90 days
Graft function (creatinine)
Time frame: 0-90 days
Delayed graft function
Time frame: 0-90 days
Pain score (numeric rating scale)
Time frame: 0-90 days
Scar quality (The Patient and Observer Scar Assessment Scale: POSAS)
Time frame: 0-90 days
Quality of Life (EQ-5D-5L score)
Time frame: 0-90days
Graft function (estimated glomerular filtration rate)
Time frame: 0-90days
ASEPSIS wound score
Time frame: 0-90days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No
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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.
Vikram Puttaswamy, MBBS principal investigator
Vascular Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Incision Negative Pressure Wound Therapy (Prevena) in people with Wound Complication, run by Royal North Shore Hospital at 1 site in Australia.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 May 2019. 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 Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Pallot (+61294631767, Linda.Pallot@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Complications (time frame: 0-90 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 14 May 2019.