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NEgative prEssure Wound Therapy in Renal Transplant

NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07065734
Acronym
NEWER
Enrollment
150
Registered
2025-07-15
Start date
2023-01-01
Completion date
2026-06-30
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplant, Transplant Complication, Wound Complication

Keywords

transplant complication, renal transplant, wound complication

Brief 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.

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

Interventions

DEVICENWPT group

Patients submitted to negative pressure wound therapy

Sponsors

Universidade do Porto
CollaboratorOTHER
Centro Hospitalar De São João, E.P.E.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients submitted to kidney transplant

Exclusion criteria

* Pediatric patients, those requiring surgical reinterventions within the first 90 days postoperative, patients allergic to NPWT components, orthotopic transplant

Design outcomes

Primary

MeasureTime frameDescription
Wound dehiscenceFirst 90 days after surgeryWound dehiscence - superficial or deep

Secondary

MeasureTime frameDescription
Wound infectionFirst 90 days after surgeryASEPSIS 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
Pain associated with incisionFirst 90 days after surgeryVisual analogue scale; score 0-10; higher score=worse outcome
Quality of life associated with incisionFirst 90 days after surgeryEQ-5D questionnaire (The 5-level quality of life version 5); score 0 -100 ; highest score=better outcome
Scar healingFirst 90 days after surgeryPOSAS score (The Patient and Observer Scar Assessment Scale); score 1-10; highest score=worse outcome

Countries

Portugal

Contacts

Primary ContactAlberto Silva, MD
u016845@chsj.min-saude.pt+351225512100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026