Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing. (PICO/2019)
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ClinicalTrials.gov Identifier: NCT04265612 |
Recruitment Status :
Recruiting
First Posted : February 11, 2020
Last Update Posted : February 12, 2021
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Condition or disease | Intervention/treatment | Phase |
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Wound Infection, Surgical | Procedure: Pico®" negative pressure dressing Procedure: Aquacel Surgical®" hydrogel dressing | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 304 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Masking Description: | External evaluator: care provider |
Primary Purpose: | Prevention |
Official Title: | Effect of the Negative Pressure Therapy Dressing Compared With the Hydrogel Dressing on Surgical Wound Infection in Cardiac Surgery. |
Actual Study Start Date : | November 5, 2019 |
Estimated Primary Completion Date : | July 13, 2021 |
Estimated Study Completion Date : | July 13, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Negative Pressure dressing
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.
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Procedure: Pico®" negative pressure dressing
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 |
Active Comparator: Aquacel hydrogel dressing
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.
|
Procedure: Aquacel Surgical®" hydrogel dressing
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. |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265612
Contact: Pilar Garrido Martín, PhD | +34 9226786293 | doctoragarrido@gmail.com | |
Contact: Patricia Rodríguez Fortúnez, PhD | +34 9226788117 | patricia.rodriguez@scren.es |
Spain | |
Pilar Garrido Martín | Recruiting |
Santa Cruz De Tenerife, Spain, 38320 | |
Contact: Pilar Garrido Martin, PhD, MD +34 922678293 doctoragarrido@gmail.com | |
Contact: Patricia Rodríguez Fortúnez, PhD +34 922678117 patricia.rodriguez@scren.es |
Study Director: | Rafael Martínez Sanz, PhD | Hospital Universitario de Canarias | |
Principal Investigator: | Pilar Garrido Martín, PhD | Hospital Universitario de Canarias |
Responsible Party: | Hospital Universitario de Canarias |
ClinicalTrials.gov Identifier: | NCT04265612 |
Other Study ID Numbers: |
PICO/2019 |
First Posted: | February 11, 2020 Key Record Dates |
Last Update Posted: | February 12, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections Wound Infection Surgical Wound Infection Postoperative Complications |
Pathologic Processes Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents |