Robert Svensson-Björk1, Julien Hasselmann2,3, Giuseppe Asciutto2,4, Moncef Zarrouk2,3, Jonas Björk5,6, Linda Bilos7, Artai Pirouzram7, Stefan Acosta2,3. 1. Vascular Diseases Research Unit, Department of Clinical Sciences, Lund University, Ruth Lundskogs gata 10, 205 02, Malmö, Sweden. Robert.Svensson_Bjork@med.lu.se. 2. Vascular Diseases Research Unit, Department of Clinical Sciences, Lund University, Ruth Lundskogs gata 10, 205 02, Malmö, Sweden. 3. Vascular Center, Skane University Hospital, Malmö, Sweden. 4. Department of Vascular Surgery, Uppsala University Hospital, Uppsala, Sweden. 5. Division of Occupational and Environmental Medicine, Lund University, Lund, Sweden. 6. Clinical Studies Sweden, Lund University, Forum South, Lund, Sweden. 7. Vascular Surgery Unit, Department of Cardiothoracic and Vascular Surgery, Linköping University Hospital, Linköping, Sweden.
Abstract
BACKGROUND: Surgical site infections (SSI) in the groin after vascular surgery are common. The aim of the study was to evaluate the effect of negative pressure wound therapy (NPWT) on SSI incidence when applied on closed inguinal incisions after endovascular aneurysm repair (EVAR). METHODS: A multicenter randomized controlled trial (RCT). Between November 2013 and December 2020, 377 incisions (336 bilateral and 41 unilateral) from elective EVAR procedures with the primary intent of fascia closure were randomized and included, receiving either NPWT or a standard dressing. In bilateral incisions, each incision randomly received the opposite dressing of the other side, thereby becoming each other's control. The primary endpoint was SSI incidence at 90 days postoperatively, analyzed on an intention-to-treat basis. Uni and bilaterally operated incisions were analyzed separately, and their respective p-values combined using Fisher's method for combining P-values. Study protocol (NCT01913132). RESULTS: The SSI incidence at 90 days postoperatively in bilateral incisions was 1.8% (n = 3/168) in the NPWT and 4.8% (n = 8/168) in the standard dressing group, and in unilateral incisions 13.3% (n = 2/15) and 11.5% (n = 3/26), respectively (combined p = 0.49). In all SSIs, bacteria were isolated from incisional wound cultures. No additional SSIs were diagnosed between 90 days and 1 year follow-up. CONCLUSIONS: No evidence of difference in SSI incidence was seen in these low-risk inguinal incisions when comparing NPWT with standard dressings after EVAR with the primary intent of fascia closure. CLINICAL TRIALS: NCT01913132.
BACKGROUND: Surgical site infections (SSI) in the groin after vascular surgery are common. The aim of the study was to evaluate the effect of negative pressure wound therapy (NPWT) on SSI incidence when applied on closed inguinal incisions after endovascular aneurysm repair (EVAR). METHODS: A multicenter randomized controlled trial (RCT). Between November 2013 and December 2020, 377 incisions (336 bilateral and 41 unilateral) from elective EVAR procedures with the primary intent of fascia closure were randomized and included, receiving either NPWT or a standard dressing. In bilateral incisions, each incision randomly received the opposite dressing of the other side, thereby becoming each other's control. The primary endpoint was SSI incidence at 90 days postoperatively, analyzed on an intention-to-treat basis. Uni and bilaterally operated incisions were analyzed separately, and their respective p-values combined using Fisher's method for combining P-values. Study protocol (NCT01913132). RESULTS: The SSI incidence at 90 days postoperatively in bilateral incisions was 1.8% (n = 3/168) in the NPWT and 4.8% (n = 8/168) in the standard dressing group, and in unilateral incisions 13.3% (n = 2/15) and 11.5% (n = 3/26), respectively (combined p = 0.49). In all SSIs, bacteria were isolated from incisional wound cultures. No additional SSIs were diagnosed between 90 days and 1 year follow-up. CONCLUSIONS: No evidence of difference in SSI incidence was seen in these low-risk inguinal incisions when comparing NPWT with standard dressings after EVAR with the primary intent of fascia closure. CLINICAL TRIALS: NCT01913132.
Authors: Gill Norman; Chunhu Shi; En Lin Goh; Elizabeth Ma Murphy; Adam Reid; Laura Chiverton; Monica Stankiewicz; Jo C Dumville Journal: Cochrane Database Syst Rev Date: 2022-04-26