Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing. (PICO/2019)

Hospital Universitario de Canarias

Status: Terminated

Conditions: Wound Infection, Surgical

Treatments: Procedure: Pico®" negative pressure dressing; Procedure: Aquacel Surgical®" hydrogel dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT04265612

PICO/2019

Details and patient eligibility

About

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".

Full 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.

Enrollment: 253 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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253 participants in 2 patient groups

Negative Pressure dressing

Experimental group

Description:

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.

Treatment:

Procedure: Pico®" negative pressure dressing

Aquacel hydrogel dressing

Active Comparator group

Description:

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.

Treatment:

Procedure: Aquacel Surgical®" hydrogel dressing