Cardiac SurgeryPICO sternalNCT06713629
The Use of PlCO-Vacuum-System on Sternal Wounds
A study testing cardiac surgery via median sternotomy in people with Cardiac Surgery and Wound Infection, run by University of Giessen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery, Wound Infection, Wound Healing Disorder
- What is being tested?
- cardiac surgery via median sternotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2019to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- History of myocardial infarction (NSTEMI or STEMI) within 14 days
- Known peripheral arterial disease
- Planned BIMA surgery.
Who cannot join
- Planned hemisternotomy or anterolateral thoracotomy
- Emergency cases
- Lack of consent
- Active therapy with immunosuppressants (including steroids)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Cardiac Surgery, Kerckhoff Heart Center
Bad Nauheim, Hesse, 61231
Cardiovascular Surgery, University Hospital Giessen
Giessen, Hesse, 35392
About this study
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.
Read the detailed description
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
- Cardiac Surgery, Wound Infection, Wound Healing Disorder
- Being tested
- cardiac surgery via median sternotomy
- Keywords
- vacuum wound dressing, PICO, sternal wound healing disorder
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgery via median sternotomyProcedure or surgery
Also called wound dressing, PlCO-Vacuum dressing
For both groups, the same median sternotomy cardiac surgery procedure
| Study group | Role | What they receive |
|---|---|---|
| PICO arm | Experimental | PICO vacuum system for post-sternotomy wound Receives: Procedure: cardiac surgery via median sternotomy |
| Control arm | Active comparator | usual commercial wound dressing Receives: Procedure: cardiac surgery via median sternotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection at 30 POD
Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively
Measured: until day 30 post-surgery
Secondary outcomes (2)
Infection at 180 Postoperative Days (POD)
Rates of superficial and/or deep sternal wound healing disorders assessed using standardized clinical criteria, including infection signs (e.g., erythema, purulent discharge), radiological imaging (if indicated), microbiological culture results, and adherence to validated classification systems such as the CDC's surgical site infection (SSI) criteria.
Measured: Up to 180 days post-surgery
Patient satisfaction
Patient satisfaction with the PICO-System in comparison to conventional plasters:
The following questions were assessed to evaluate participant satisfaction:
- The wound dressing causes discomfort.
- My wound has achieved a satisfactory cosmetic appearance.
- I experienced pain during wound dressing changes.
- I am generally satisfied with the care provided.
For each question, the following response options were offered:
- Fully applies
- Partially applies
- Neutral
- Partially does not apply
- Does not apply
Measured: until day 7 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Jul 2019
- Primary completion29 Feb 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc., Kerckhoff Heart Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713629
- Sponsor's protocol ID
- AZ 62/19
- Acronym
- PICO sternal
- Status last verified
- Nov 2024
- First submitted
- 9 Apr 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of PlCO-Vacuum-System on Sternal Wounds
- ClinicalTrials.gov ID
- NCT06713629
- Acronym / sponsor ID
- PICO sternal / AZ 62/19
- Conditions
- Cardiac Surgery, Wound Infection, Wound Healing Disorder
- Keywords
- vacuum wound dressing, PICO, sternal wound healing disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc., Kerckhoff Heart Center
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICO arm | Experimental | Procedure: cardiac surgery via median sternotomyPICO vacuum system for post-sternotomy wound |
| Control arm | Active comparator | Procedure: cardiac surgery via median sternotomyusual commercial wound dressing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Planned hemisternotomy or anterolateral thoracotomy
- Emergency cases
- Lack of consent
- Active therapy with immunosuppressants (including steroids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac surgery via median sternotomyAlso: wound dressing, PlCO-Vacuum dressingFor both groups, the same median sternotomy cardiac surgery procedure | Procedure or surgery | Control arm, PICO arm |
Primary outcome
Infection at 30 POD
Time frame: until day 30 post-surgery
Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively
2 secondary outcomes
Infection at 180 Postoperative Days (POD)
Time frame: Up to 180 days post-surgery
Patient satisfaction
Time frame: until day 7 post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac surgery via median sternotomy in people with Cardiac Surgery and Wound Infection, run by University of Giessen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection at 30 POD (time frame: until day 30 post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.