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

Not Applicable

Terminated

• Conditions: Wound Infection, Surgical
• Interventions: Procedure: Aquacel Surgical®" hydrogel dressing; Procedure: Pico®" negative pressure dressing

• Registration Number: NCT04265612
• Lead Sponsor: Hospital Universitario de Canarias

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".

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 Timeline

• Study Start: 2019-11-05
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Status Verified: 2021-02
• Primary Completion: 2021-07-13
• Study Completion: 2022-05-18
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 253

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aquacel hydrogel dressing	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.
Negative Pressure dressing	Pico®" 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.

Primary Outcome Measures

Name	Time	Method
Incidence of infection of the sternal surgical wound.	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.

Trial Locations

Locations (1)

Pilar Garrido Martín; 🇪🇸 Santa Cruz De Tenerife, Spain