Effects of Preventive Negative Pressure Wound Therapy With PICO on Surgical Wounds of Kidney Transplant Patients

NCT02558764 | Withdrawn

• 1 other identifier: 001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Advances in surgical techniques and immunosuppression (IS) have led to an appreciable reduction in postoperative complications following kidney transplantation. However, surgical site events (SSE) including surgical site infections (SSI) and other wound complications are still very common and they can limit these improved outcomes and result in prolonged hospitalization, hospital readmission and reoperation, consequently increasing overall transplant cost. Negative pressure wound therapy (NPWT) is a concept introduced initially to assist in the treatment of chronic open wounds. This technique uses a negative pressure unit and specific dressings that help to hold the incision edges together, redistribute lateral tension, reduce edema, stimulate perfusion and protect the surgical site from external infectious sources. Thus, it provides faster wound healing and shortens hospital stay. Recently, there has been growing interest in using portable NPWT devices on closed incisions after surgery to prevent potential SSI and other wound complications in high-risk patients. Investigations regarding this technique in various surgical settings have shown that it can reduce the risk of SSI and other wound complications. These studies concluded that any patient undergoing transplantation should be considered as 'high-risk' and should receive this treatment. To date, no studies are reported in literature exploring the effects of preventive use of portable NPWT devices on surgical wounds in the setting of organ transplantation. The aim of our study is to compare a portable NPWT device (PICO, Smith \& Nephew, London UK) to conventional gauze dressings in patients undergoing kidney transplantation (KT) surgery.

Conditions

Wound Complications

Outcome Measures

Primary Outcomes (1)

• post-kidney transplant wound complication rates

  Primary outcome of this study will be 'post- KT wound complication (superficial wound dehiscence, evisceration, seromas, incisional hernias, wound infections and wound necrosis) rates'. The potential relation of these complications with PICO application will be assessed.

  up to 12 months

Study Arms (2)

Control

NO INTERVENTION

No intervention; basic wound contact absorbent dressings will be used as per current standard of care.

PICO

OTHER

PICO device will be used for prevention of wound complications. This is a portable negative pressure wound treatment device. Patients will have the device for 7 days after undergoing kidney transplant surgery.

Device: portable (pocket) negative pressure wound treatment device

Interventions

portable (pocket) negative pressure wound treatment device DEVICE

PICO device will be applied to the surgical wounds of kidney transplant patients who are enrolled in the PICO group. These patients will have this device on for 7 days after undergoing kidney transplant surgery.

Also known as: PICO, Smith & Nephew, London UK

PICO

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years of age)
• female/male cadaveric kidney transplant recipients who have a preoperative order for standard induction immunosuppression protocol (basiliximab and methylprednisolone) and give written consent will be included in this study.

You may not qualify if:

• Patients who have a pre-operative order for a non-standard induction immunosuppression regimen
• Patients deemed not capable to take care for the PICO device
• Multi-organ transplant recipients (simultaneous liver-kidney transplant, simultaneous kidney-pancreas transplant)
• Dual KT recipients (simultaneous kidney-kidney transplant)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 24, 2015
• Study Start: December 7, 2016
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: October 28, 2022

Record last verified: 2015-09