The Use of PlCO-Vacuum-System on Sternal Wounds

NCT06713629 | Completed DMC

• 1 other identifier: AZ 62/19
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

Brief Summary

The use of a vacuum-assisted wound closure system (PICO, Fa. Smith \& Nephew) is being investigated to determine whether it reduces the incidence of sternal wound healing disorders compared to conventional wound care with plaster.

Conditions

Cardiac Surgery; Wound Infection; Wound Healing Disorder

Keywords

vacuum wound dressing; PICO; sternal wound healing disorder

Outcome Measures

Primary Outcomes (1)

• Infection at 30 POD

  Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively

  until day 30 post-surgery

Secondary Outcomes (2)

• Infection at 180 Postoperative Days (POD)

  Up to 180 days post-surgery

• Patient satisfaction

  until day 7 post-surgery

Other Outcomes (1)

• Cost-Effectiveness of PICO Wound Dressing Compared to Conventional Plaster Dressing

  From surgery to day 180 post-surgery

Study Arms (2)

PICO arm

EXPERIMENTAL

PICO vacuum system for post-sternotomy wound

Procedure: cardiac surgery via median sternotomy

Control arm

ACTIVE COMPARATOR

usual commercial wound dressing

Procedure: cardiac surgery via median sternotomy

Interventions

cardiac surgery via median sternotomy PROCEDURE

For both groups, the same median sternotomy cardiac surgery procedure

Also known as: wound dressing, PlCO-Vacuum dressing

Control arm; PICO arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing cardiac surgery by means of median sternotomy and exhibiting more than one of the following risk factors:
• Diabetes mellitus (treated with oral antidiabetics and/or insulin)
• LVEF\<40%
• COPD
• Female gender
• Adipositas (BMI \> 30kg/m2)
• History of myocardial infarction (NSTEMI or STEMI) within 14 days
• Known peripheral arterial disease
• Planned BIMA surgery.

You may not qualify if:

• Planned hemisternotomy or anterolateral thoracotomy
• Emergency cases
• Lack of consent
• Active therapy with immunosuppressants (including steroids)

Sponsors & Collaborators

• University of Giessen: lead
• Smith & Nephew, Inc.: collaborator
• Kerckhoff Heart Center: collaborator

Study Sites (2)

Cardiac Surgery, Kerckhoff Heart Center

Bad Nauheim, Hesse, 61231, Germany

Location

Cardiovascular Surgery, University Hospital Giessen

Giessen, Hesse, 35392, Germany

Location

MeSH Terms

Conditions

Wound Infection

Interventions

Bandages

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

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

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: December 3, 2024
• Study Start: July 1, 2019
• Primary Completion: February 29, 2024
• Study Completion: May 30, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)