NCT07065734

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
2mo left

Started Jan 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2023Jun 2026

Study Start

First participant enrolled

January 1, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

3.4 years

First QC Date

June 23, 2025

Last Update Submit

July 10, 2025

Conditions

Transplant ComplicationRenal TransplantWound Complication

Keywords

transplant complicationrenal transplantwound complication

Outcome Measures

Primary Outcomes (1)

  • Wound dehiscence

    Wound dehiscence - superficial or deep

    First 90 days after surgery

Secondary Outcomes (4)

  • Wound infection

    First 90 days after surgery

  • Pain associated with incision

    First 90 days after surgery

  • Quality of life associated with incision

    First 90 days after surgery

  • Scar healing

    First 90 days after surgery

Study Arms (2)

NPWT group

ACTIVE COMPARATOR

Patients who received negative pressure wound therapy

Device: NWPT group

Standard group

NO INTERVENTION

Patients who received standard dressing

Interventions

NWPT groupDEVICE

Patients submitted to negative pressure wound therapy

NPWT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients submitted to kidney transplant

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São João University Hospital

Porto, Portugal

RECRUITING

Study Officials

  • João Alturas Silva, PhD

    São João University Hospital

    STUDY DIRECTOR

Central Study Contacts

Alberto Silva, MD

CONTACT

+351225512100u016845@chsj.min-saude.pt

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 15, 2025

Study Start

January 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations

PT(1)