Wound Infection, SurgicalPICO/2019NCT04265612
Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing.
A study testing Pico®" negative pressure dressing and Aquacel Surgical®" hydrogel dressing in people with Wound Infection, Surgical, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
The objective of the study is to measure the efficacy of the use of single-use portable negative pressure therapy (PICO ®) in the prevention of surgical wound infections (SSI) from cardiac surgery under extracorporeal circulation compared to single-use hydrocolloid dressings "Aquacel Surgical". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection, Surgical
- What is being tested?
- Pico®" negative pressure dressing and Aquacel Surgical®" hydrogel dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2019to 18 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective or emergency cardiac surgery with extracorporeal circulation heart surgery who will have a median sternotomy.
- Who signs Informed Consent after agreeing to participate in the microbiological study.
Who cannot join
- Patients undergoing emergency cardiac surgery that does not time to randomization and/or coding.
- Patients with immunocompromised haematological diseases.
- Patients who are allergic or present some hypersensitivity to the dressing or excipient.
- Patients who are participating in another experimental study.
- Patients who, due to their fragility or comorbidity, the surgeon considers that they should not undergo randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery.
The objective of the study is to measure the efficacy of the use of single-use portable negative pressure therapy (PICO ®) in the prevention of surgical wound infections (SSI) from cardiac surgery under extracorporeal circulation compared to single-use hydrocolloid dressings "Aquacel Surgical".
Read the detailed description
Negative pressure therapy is a type of physical therapy for wound healing that is based on the application of a negative pressure (void) in the wound bed.
Negative pressure therapy is based on the application of a subatmospheric pressure in the wound bed to trigger a whole series of mechanisms, and that to a greater or lesser degree, and in a synergistic manner, act by creating or improving the conditions for the healing process to develop (negative pressure therapy).
All these mechanisms act by diminishing the possibility of creating an appropriate medium for the growth of pathogenic germs.
Today, negative pressure therapy is also used to create ideal conditions in surgical wounds to prevent or reduce the risk of local complications, is what we call incisional negative pressure therapy.
- Conditions
- Wound Infection, Surgical
- Being tested
- Pico®" negative pressure dressing, Aquacel Surgical®" hydrogel dressing
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pico®" negative pressure dressingProcedure or surgery
Pico®" negative pressure dressing that will be placed in the operating room in both sternal wound and saphenectomy.The dressing will remain on for 7 days without waking up, unless it is saturated, in which case only the dressing will be changed
Aquacel Surgical®" hydrogel dressingProcedure or surgery
Aquacel Surgical®" hydrogel dressing that will be placed in the operating room in both sternal wound and saphenectomy. This dressing will remain in place for 7 days without getting up, unless it has become saturated, in which case, only the dressing will be changed.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure dressing | Experimental | Pico®" negative pressure dressing that will be placed in the operating room in both sternal wound and saphenectomy. This dressing will remain in place for 7 days without getting up, unless it has become saturated, in which case, only the dressing will be changed. Receives: Procedure: Pico®" negative pressure dressing |
| Aquacel hydrogel dressing | Active comparator | Aquacel Surgical®" hydrogel dressing that will be placed in the operating room in both sternal wound and saphenectomy. This dressing will remain in place for 7 days without getting up, unless it has become saturated, in which case, only the dressing will be changed. Receives: Procedure: Aquacel Surgical®" hydrogel dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infection of the sternal surgical wound.
The state of the surgical wound will be assessed and recorded on the wound care data collection sheet. Note whether the wound looks good or not and whether there are any complications: exudate, appearance of the wound, necrosis of the wound edges, redness, maceration of the wound or wound dehiscence.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start5 Nov 2019
- Primary completion13 Jul 2021
- Study completion18 May 2022
Why it stopped: Lack of funds preventing further payment of the trial insurance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Infection, SurgicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Martínez Sanz, PhD, Study director, Hospital Universitario de CanariasPilar Garrido Martín, PhD, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265612
- Sponsor's protocol ID
- PICO/2019
- Acronym
- PICO/2019
- Status last verified
- Feb 2021
- First submitted
- 5 Nov 2019
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT04265612
- Acronym / sponsor ID
- PICO/2019 / PICO/2019
- Conditions
- Wound Infection, Surgical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funds preventing further payment of the trial insurance
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 11 Feb 2020 (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 objective of the study is to measure the efficacy of the use of single-use portable negative pressure therapy (PICO ®) in the prevention of surgical wound infections (SSI) from cardiac surgery under extracorporeal circulation compared to single-use hydrocolloid dressings "Aquacel Surgical".
Detailed description
Negative pressure therapy is a type of physical therapy for wound healing that is based on the application of a negative pressure (void) in the wound bed.
Negative pressure therapy is based on the application of a subatmospheric pressure in the wound bed to trigger a whole series of mechanisms, and that to a greater or lesser degree, and in a synergistic manner, act by creating or improving the conditions for the healing process to develop (negative pressure therapy).
All these mechanisms act by diminishing the possibility of creating an appropriate medium for the growth of pathogenic germs.
Today, negative pressure therapy is also used to create ideal conditions in surgical wounds to prevent or reduce the risk of local complications, is what we call incisional negative pressure therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure dressing | Experimental | Procedure: Pico®" negative pressure dressingPico®" negative pressure dressing that will be placed in the operating room in both sternal wound and saphenectomy. This dressing will remain in place for 7 days without getting up, unless it has become saturated, in which case, only the dressing will be changed. |
| Aquacel hydrogel dressing | Active comparator | Procedure: Aquacel Surgical®" hydrogel dressingAquacel Surgical®" hydrogel dressing that will be placed in the operating room in both sternal wound and saphenectomy. This dressing will remain in place for 7 days without getting up, unless it has become saturated, in which case, only the dressing will be changed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing elective or emergency cardiac surgery with extracorporeal circulation heart surgery who will have a median sternotomy.
- Who signs Informed Consent after agreeing to participate in the microbiological study.
Key exclusion criteria (5 listed)
- Patients undergoing emergency cardiac surgery that does not time to randomization and/or coding.
- Patients with immunocompromised haematological diseases.
- Patients who are allergic or present some hypersensitivity to the dressing or excipient.
- Patients who are participating in another experimental study.
- Patients who, due to their fragility or comorbidity, the surgeon considers that they should not undergo randomization.
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 |
|---|---|---|
| Pico®" negative pressure dressingPico®" negative pressure dressing that will be placed in the operating room in both sternal wound and saphenectomy.The dressing will remain on for 7 days without waking up, unless it is saturated, in which case only the dressing will be changed | Procedure or surgery | Negative Pressure dressing |
| Aquacel Surgical®" hydrogel dressingAquacel Surgical®" hydrogel dressing that will be placed in the operating room in both sternal wound and saphenectomy. This dressing will remain in place for 7 days without getting up, unless it has become saturated, in which case, only the dressing will be changed. | Procedure or surgery | Aquacel hydrogel dressing |
Primary outcome
Incidence of infection of the sternal surgical wound.
Time frame: 1-3 months
The state of the surgical wound will be assessed and recorded on the wound care data collection sheet. Note whether the wound looks good or not and whether there are any complications: exudate, appearance of the wound, necrosis of the wound edges, redness, maceration of the wound or wound dehiscence.
Results and safety
The study was stopped early (reason given: Lack of funds preventing further payment of the trial insurance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
Rafael Martínez Sanz, PhD study director
Hospital Universitario de Canarias
Pilar Garrido Martín, PhD principal investigator
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pico®" negative pressure dressing and Aquacel Surgical®" hydrogel dressing in people with Wound Infection, Surgical, run by Hospital Universitario de Canarias at 1 site in Spain.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 was stopped early (reason given: Lack of funds preventing further payment of the trial insurance). Results are not available in the source record.
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?
Incidence of infection of the sternal surgical wound. (time frame: 1-3 months). 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 21 Jul 2023.