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NCT Number: NCT07065734

NEgative prEssure Wound Therapy in Renal Transplant

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.

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Key information

Conditions

Transplant Complication Renal Transplant Wound Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NWPT group

Device

Patients submitted to negative pressure wound therapy

Primary outcomes

  1. Wound dehiscence

    Time frame: First 90 days after surgery

    Wound dehiscence - superficial or deep

Secondary outcomes

  1. Wound infection

    Time frame: First 90 days after surgery

    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

  2. Pain associated with incision

    Time frame: First 90 days after surgery

    Visual analogue scale; score 0-10; higher score=worse outcome

  3. Quality of life associated with incision

    Time frame: First 90 days after surgery

    EQ-5D questionnaire (The 5-level quality of life version 5); score 0 -100 ; highest score=better outcome

  4. Scar healing

    Time frame: First 90 days after surgery

    POSAS score (The Patient and Observer Scar Assessment Scale); score 1-10; highest score=worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Silva, MD

CONTACT

[email protected]

+351225512100

Sponsors and collaborators

Lead sponsor

Centro Hospitalar De São João, E.P.E.

Other

Collaborators

  • Universidade do Porto

Registry information

Official study title

NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial

Acronym: NEWER

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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