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The Use of PlCO-Vacuum-System on Sternal Wounds

NCT ID: NCT06713629

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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Median sternotomy remains the standard surgical approach for most cardiac surgeries. However, postoperative wound infections can occur and may progress to mediastinitis, a life-threatening complication with significant mortality. This risk is particularly pronounced in cases where sternal perfusion is compromised, such as when one or both internal mammary arteries are harvested during coronary artery bypass grafting. In such scenarios, the incidence of sternal wound healing disturbances is estimated to range from 2% to 7%.

Several strategies aim to reduce the risk of sternal wound infections. One approach involves external stabilization using a thoracic vest, which has been shown to significantly decrease sternal instability and healing disorders when implemented early in the postoperative period. Another approach utilizes negative pressure wound therapy, which has demonstrated efficacy in reducing sternal wound healing complications in prior studies involving systems like Prevena (Fa. KCI).

The PICO-System operates with a distinct vacuum pressure mechanism and a unique film design compared to the Prevena system. To date, no prospective randomized studies have evaluated the PICO-System for its effectiveness in reducing sternal healing disturbances, sternal instability, and mediastinitis. This study aims to compare conventional plaster wound care with the PICO vacuum system in a randomized, prospective design, assessing outcomes up to six months postoperatively.

Conditions

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Cardiac Surgery Wound Infection Wound Healing Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PICO arm

PICO vacuum system for post-sternotomy wound

Group Type EXPERIMENTAL

cardiac surgery via median sternotomy

Intervention Type PROCEDURE

For both groups, the same median sternotomy cardiac surgery procedure

Control arm

usual commercial wound dressing

Group Type ACTIVE_COMPARATOR

cardiac surgery via median sternotomy

Intervention Type PROCEDURE

For both groups, the same median sternotomy cardiac surgery procedure

Interventions

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cardiac surgery via median sternotomy

For both groups, the same median sternotomy cardiac surgery procedure

Intervention Type PROCEDURE

Other Intervention Names

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wound dressing PlCO-Vacuum dressing

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role collaborator

Kerckhoff Heart Center

OTHER

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardiac Surgery, Kerckhoff Heart Center

Bad Nauheim, Hesse, Germany

Site Status

Cardiovascular Surgery, University Hospital Giessen

Giessen, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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AZ 62/19

Identifier Type: -

Identifier Source: org_study_id