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Recruiting NCT07065734

NEgative prEssure Wound Therapy in Renal Transplant

Phase IV Interventional Transplant Complication Renal Transplant Wound Complication

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗