NEgative prEssure Wound Therapy in Renal Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NWPT group.
- Who it may be relevant to
- Registry conditions: Transplant Complication, Renal Transplant, Wound Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial
Overview
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
- Device NWPT group
Patients submitted to negative pressure wound therapy
Primary outcome measures
- Wound dehiscence [Time frame: First 90 days after surgery]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Portugal · 1 center
- São João University Hospital — Porto
Identifiers
NCT: NCT07065734 · 351-2022