Effect of the Negative Pressure Therapy Dressing Compared With Hydrogel Dressing.

NCT04265612 | Terminated DMC

• 1 other identifier: PICO/2019
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

Wound Infection, Surgical

Outcome Measures

Primary Outcomes (1)

• 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.

  1-3 months

Study Arms (2)

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.

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.

Procedure: Aquacel Surgical®" hydrogel dressing

Interventions

Pico®" negative pressure dressing PROCEDURE

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

Negative Pressure dressing

Aquacel Surgical®" hydrogel dressing PROCEDURE

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.

Aquacel hydrogel dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Pilar Garrido Martín

Santa Cruz de Tenerife, 38320, Spain

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rafael Martínez Sanz, PhD

  Hospital Universitario de Canarias

  STUDY DIRECTOR

• Pilar Garrido Martín, PhD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: External evaluator: care provider
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: February 11, 2020
• Study Start: November 5, 2019
• Primary Completion: July 13, 2021
• Study Completion: May 18, 2022
• Last Updated: July 21, 2023

Record last verified: 2021-02

Locations

ES (1)