Prophylactic use of incisional negative pressure wound therapy for groin incisions in vascular surgery: randomized clinical trial.

Background: The efficacy of incisional negative pressure wound therapy (iNPWT) in preventing surgical site infections (SSIs) after infrainguinal vascular surgery remains unclear. This study compared iNPWT with standard gauze dressings to determine the effects on SSI incidence and quality of life.

Methods: Patients undergoing infrainguinal vascular surgery were recruited to a regional randomized clinical trial. All patients had a groin incision for either thromboendarterectomy only with a vein or synthetic patch or hybrid procedures with thromboendarterectomy and concurrent endovascular treatment. The control and intervention groups received sterile gauze and iNPWT dressings, respectively. The primary endpoint was the incidence of SSIs within 30 days, measured using the Additional treatment, Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and inpatient Stay (ASEPSIS) scoring protocol. Secondary endpoints were scores on the Wound Quality of Life and EQ-5D™ three-level (EQ-5D-3L™) questionnaires.

Results: Of the 123 patients randomized, 109 (89%) completed the study. The incidence of SSI was similar in the intervention and control groups (15% versus 25%, respectively; P = 0.340), but was higher in patients with a body mass index (BMI) ≥ 25 kg/m2 than in those with a BMI < 25 kg/m2 (52% versus 21%, respectively). Wound Quality of Life mean scores were similar in the control and intervention groups (10.60 versus 12.85, respectively; P = 0.322); however, the intervention group reported a larger negative impact on everyday life than the control group (7.40 versus 4.91 for the everyday life domain, respectively; P = 0.048). There were no significant differences between the two groups in EQ-5D-3L™ scores.

Conclusion: The similar distribution of SSIs regardless of the type of wound dressing, in addition to the negative impact on everyday life, does not support the general use of iNPWT in this or similar patient cohorts. The unique aspect of this trial is the patient perspective on the use of iNPWT, revealing a divergence between the views of patients and healthcare providers regarding optimal wound care. In the setting of individualized care, there may be a place for iNPWT in selected patients with a high BMI and excessive perioperative bleeding, which are associated with a higher SSI risk.

Registration number: NCT03395613 (https://clinicaltrials.gov).