Transplant ComplicationPhase 4NEWERNCT07065734
NEgative prEssure Wound Therapy in Renal Transplant
A Phase 4 study testing NWPT group in people with Transplant Complication and Renal Transplant, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
Trial summary
This is a prospective study involving patients undergoing open renal transplant. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Complication, Renal Transplant, Wound Complication
- What is being tested?
- NWPT group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2023to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- All patients submitted to kidney transplant
Who cannot join
- Pediatric patients, those requiring surgical reinterventions within the first 90 days postoperative, patients allergic to NPWT components, orthotopic transplant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
São João University Hospital
Porto
Alberto Silva, MD, +351 225 512 100, u016845@chsj.min-saude.pt
About this study
Official title: NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial
This is a prospective study involving patients undergoing open renal transplant. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings.
Read the detailed description
This is a prospective study involving patients undergoing open renal transplant between January 2023 and August 2024. Pediatric patients, those requiring surgical reinterventions within the first 3 postoperative months, and patients allergic to NPWT components were excluded from the study. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings. NPWT (PICO by Smith \& Nephew) was applied intraoperatively at 80 mmHg and maintained for 7 days. Wound evaluations were performed at 7, 14, 30, and 90 days post-operatively. If dehiscence was present, it was classified as either deep or superficial based on the involvement of the aponeurosis. Patients were assessed for wound infection using the ASEPSIS score, pain with a visual analogue scale, and quality of life using the EQ-5D questionnaire. Scar healing was also evaluated at 30 and 90 days post-operatively with the POSAS score
- Being tested
- NWPT group
- Keywords
- transplant complication, renal transplant, wound complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NWPT groupDevice
Patients submitted to negative pressure wound therapy
| Study group | Role | What they receive |
|---|---|---|
| NPWT group | Active comparator | Patients who received negative pressure wound therapy Receives: Device: NWPT group |
| Standard group | No intervention | Patients who received standard dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound dehiscence
Wound dehiscence - superficial or deep
Measured: First 90 days after surgery
Secondary outcomes (4)
Wound infection
ASEPSIS score - (Additional treatment, Serous discharge, Erythema, Purulen exudates, Separation of deep tissues, Isolation of bacteria, Stay in hospital score); 0-10 points; higher score = worse outcome
Measured: First 90 days after surgery
Pain associated with incision
Visual analogue scale; score 0-10; higher score=worse outcome
Measured: First 90 days after surgery
Quality of life associated with incision
EQ-5D questionnaire (The 5-level quality of life version 5); score 0 -100 ; highest score=better outcome
Measured: First 90 days after surgery
Scar healing
POSAS score (The Patient and Observer Scar Assessment Scale); score 1-10; highest score=worse outcome
Measured: First 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jan 2023
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto
- Responsible party
- Principal investigator, Alberto Costa Silva, Centro Hospitalar De São João, E.P.E.
- Investigators
- João Alturas Silva, PhD, Study director, São João University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065734
- Sponsor's protocol ID
- 351-2022
- Acronym
- NEWER
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon reasonable request after consideration from local Ethics Comission
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial
- ClinicalTrials.gov ID
- NCT07065734
- Acronym / sponsor ID
- NEWER / 351-2022
- Keywords
- transplant complication, renal transplant, wound complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Collaborators
- Universidade do Porto
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jul 2025 (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 is a prospective study involving patients undergoing open renal transplant. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings.
Detailed description
This is a prospective study involving patients undergoing open renal transplant between January 2023 and August 2024. Pediatric patients, those requiring surgical reinterventions within the first 3 postoperative months, and patients allergic to NPWT components were excluded from the study. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings. NPWT (PICO by Smith \& Nephew) was applied intraoperatively at 80 mmHg and maintained for 7 days. Wound evaluations were performed at 7, 14, 30, and 90 days post-operatively. If dehiscence was present, it was classified as either deep or superficial based on the involvement of the aponeurosis. Patients were assessed for wound infection using the ASEPSIS score, pain with a visual analogue scale, and quality of life using the EQ-5D questionnaire. Scar healing was also evaluated at 30 and 90 days post-operatively with the POSAS score
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPWT group | Active comparator | Device: NWPT groupPatients who received negative pressure wound therapy |
| Standard group | No intervention | –Patients who received standard dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients submitted to kidney transplant
Key exclusion criteria (1 listed)
- Pediatric patients, those requiring surgical reinterventions within the first 90 days postoperative, patients allergic to NPWT components, orthotopic transplant
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 |
|---|---|---|
| NWPT groupPatients submitted to negative pressure wound therapy | Device | NPWT group |
Primary outcome
Wound dehiscence
Time frame: First 90 days after surgery
Wound dehiscence - superficial or deep
4 secondary outcomes
Wound infection
Time frame: First 90 days after surgery
Pain associated with incision
Time frame: First 90 days after surgery
Quality of life associated with incision
Time frame: First 90 days after surgery
Scar healing
Time frame: First 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon reasonable request after consideration from local Ethics Comission
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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.
João Alturas Silva, PhD study director
São João University Hospital
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 NWPT group in people with Transplant Complication and Renal Transplant, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Silva, MD (+351225512100, u016845@chsj.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound dehiscence (time frame: First 90 days after surgery). 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 15 Jul 2025.