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NEgative prEssure Wound Therapy in Renal Transplant (NEWER)

C

Centro Hospitalar De São João, E.P.E.

Status and phase

Enrolling
Phase 4

Conditions

Wound Complication
Transplant Complication
Renal Transplant

Treatments

Device: NWPT group

Study type

Interventional

Funder types

Other

Identifiers

NCT07065734
351-2022

Details and patient eligibility

About

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.

Full 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

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

NPWT group
Active Comparator group
Description:
Patients who received negative pressure wound therapy
Treatment:
Device: NWPT group
Standard group
No Intervention group
Description:
Patients who received standard dressing

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Alberto Silva, MD

Data sourced from clinicaltrials.gov

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