Negative Pressure Wound Therapy for the Prevention of Surgical Site Infections Using Fascia Closure After EVAR-A Randomized Trial.
Journal
World journal of surgery
ISSN: 1432-2323
Titre abrégé: World J Surg
Pays: United States
ID NLM: 7704052
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
accepted:
29
08
2022
pubmed:
15
10
2022
medline:
9
11
2022
entrez:
14
10
2022
Statut:
ppublish
Résumé
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). 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). 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. 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. NCT01913132.
Sections du résumé
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.
Identifiants
pubmed: 36241857
doi: 10.1007/s00268-022-06740-5
pii: 10.1007/s00268-022-06740-5
pmc: PMC9636293
doi:
Banques de données
ClinicalTrials.gov
['NCT01913132']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3111-3120Informations de copyright
© 2022. The Author(s).
Références
Surg Infect (Larchmt). 2020 May;21(4):384-390
pubmed: 31829833
Infect Control Hosp Epidemiol. 2011 Feb;32(2):101-14
pubmed: 21460463
Ann Surg. 1972 Sep;176(3):321-33
pubmed: 4262892
Ann R Coll Surg Engl. 2019 Jan;101(1):14-16
pubmed: 30482052
Eur J Vasc Endovasc Surg. 2017 Jul;54(1):104-115
pubmed: 28438400
Br J Surg. 2019 Mar;106(4):310-318
pubmed: 30725478
J Endovasc Ther. 2011 Dec;18(6):789-96
pubmed: 22149228
Surg Infect (Larchmt). 2017 Apr;18(3):303-310
pubmed: 28128684
Cochrane Database Syst Rev. 2017 Feb 21;2:CD010185
pubmed: 28221665
Lancet. 1986 Feb 8;1(8476):311-3
pubmed: 2868173
Int J Angiol. 2018 Mar;27(1):13-22
pubmed: 29483761
Eur J Vasc Endovasc Surg. 2021 Mar;61(3):383-394
pubmed: 33309488
Br J Surg. 2018 Feb;105(3):182-191
pubmed: 29405280
J Vasc Surg. 2019 Nov;70(5):1700-1710.e6
pubmed: 31126768
Eur J Vasc Endovasc Surg. 2015 Feb;49(2):166-73
pubmed: 25549577
Int J Angiol. 2019 Jun;28(2):124-129
pubmed: 31384110
Int J Surg. 2020 Apr;76:94-100
pubmed: 32142903
Int Wound J. 2021 Apr;18(2):164-175
pubmed: 33236858
Vascular. 2020 Jun;28(3):274-284
pubmed: 31955666
Cochrane Database Syst Rev. 2022 Apr 26;4:CD009261
pubmed: 35471497