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Randomized Controlled Trial
. 2025 Jun 6;15(1):19960.
doi: 10.1038/s41598-025-02533-7.

A prospective randomized study that compares three different dressings for the prevention of surgical site infections following major heart surgery

María Jesús Pérez-Granda  1   2   3   4 , Gregorio Cuerpo  5 , José María Barrio  6   7 , Maricela Valerio  8   6 , Patricia Muñoz  8   6   9 , Ángel González Pinto  5   9 , Dominique Encarnación Valencia  5 , Félix Sánchez Vicario  5 , Emilio Bouza  10   11   12 ; Cardiovascular Infection Study Group
Collaborators, Affiliations
Randomized Controlled Trial

A prospective randomized study that compares three different dressings for the prevention of surgical site infections following major heart surgery

María Jesús Pérez-Granda et al. Sci Rep. .

Abstract

Surgical site infection (SSI) is among the most common complication of major heart surgery patients with incidences ranging from 0.5 to 16.5%. Our aim was to compare the incidence, etiology and prognosis of surgical wound infection in three groups of patients with three different type of wound dressing used in a large cohort of patients undergoing cardiac surgery requiring median sternotomy (MHS). This was a randomized, prospective clinical study conducted in 900 adults undergoing MHS at our center from October 10, 2019 to February 22, 2022. Before surgical closure, patients were randomized to 3 different wound dressing groups (300 patients per group): A) conventional gauze (Mepore®), B) Absorbent: polyurethane foam (Mepilex®), or C) Vacuum-negative-pressure therapy (NPWT) wound dressing (PICO®, Smith & Nephew S.A.). Overall, 900 patients were randomized as follows: 300 patients in each group received conventional, absorbent or vacuum wound dressing respectively. Rates of SSI in groups A, B and C were respectively 2.3%, 3% and 3% for superficial SSI (sSSI) (p = 0.848) and 2%, 2% and 0.7% for postsurgical mediastinitis (PSM) (p = 0.313). Mortality in the whole group was 4.4% there being no significant differences between the three groups (4.7%, 5.7% and 3% respectively; p = 0.277). The NPWT system was better at preventing PSM than the other dressings only in the subgroup of patients undergoing coronary artery bypass graft surgery (CABG) with mammary artery grafts. We have not been able to demonstrate significant differences in the incidence of SSI in the whole series with any of the different dressings. The newer, more expensive, NPWT dressing were more effective only at preventing Post-Surgical Mediastinitis in patients undergoing CABG with internal mammary artery grafts. ClinicalTrials.gov identifier (NCT number): NCT03905213.

Keywords: Major heart surgery; Prevention; Surgical wound infection.

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Conflict of interest statement

Declarations. Ethical approval: The Ethics Committee of our institution (Hospital Gregorio Marañon) approved the study (code MICRO.HGUGM.2018–008) and all patients gave their written informed consent before inclusion in this study. Consent was obtained on admission to hospital prior to surgery. Competing interests: The authors declare that they have no conflicts of interest.

Figures

Fig. 1
Fig. 1
a.Consort diagram b. Patient recruitmen.
Fig. 2
Fig. 2
Cumulative incidence of mediastinitis.
Fig. 3
Fig. 3
Etiology of the episodes of mediastinitis.
See this image and copyright information in PMC

References

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    1. Pérez-Granda, M. J. et al. Infectious complications following major heart surgery from the day of the surgery to hospital discharge. BMC Infect Dis.24(1), 73 (2024). - PMC - PubMed

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