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Multicenter parallel randomized trial evaluating incisional negative pressure wound therapy for the prevention of surgical site infection after lower extremity bypass

Rezk, Francis LU orcid ; Åstrand, Håkan ; Svensson-Björk, Robert LU orcid ; Hasselmann, Julien LU ; Nyman, Johan LU ; Butt, Talha LU ; Bilos, Linda LU ; Pirouzram, Artai and Acosta, Stefan LU orcid (2024) In Journal of Vascular Surgery 79(4). p.4-940
Abstract

Objective: Incisional negative pressure wound therapy (iNPWT) applied over all incisions after lower extremity bypass in the prevention of surgical site infections (SSIs) is unclear. The primary and secondary aims of this study were to investigate if prophylactic iNPWT after the elective lower extremity bypass prevents SSI and other surgical wound complications. Methods: This was a multicenter, parallel, randomized controlled trial. Patients undergoing elective lower extremity bypass in 3 hospitals were randomized to either iNPWT or standard dressings. SSIs or other wound complications were assessed within the first 90 days by wound care professionals blinded to the randomized result. The validated Additional treatment, Serous... (More)

Objective: Incisional negative pressure wound therapy (iNPWT) applied over all incisions after lower extremity bypass in the prevention of surgical site infections (SSIs) is unclear. The primary and secondary aims of this study were to investigate if prophylactic iNPWT after the elective lower extremity bypass prevents SSI and other surgical wound complications. Methods: This was a multicenter, parallel, randomized controlled trial. Patients undergoing elective lower extremity bypass in 3 hospitals were randomized to either iNPWT or standard dressings. SSIs or other wound complications were assessed within the first 90 days by wound care professionals blinded to the randomized result. The validated Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) score was used to objectively assess the wounds. ASEPSIS score ≥21 is defined as an SSI. Unilateral and bilateral groups were analyzed with the Fisher exact test and the McNemar test, respectively. Results: In the unilateral group (n = 100), the incidence of SSI in the iNPWT group was 34.9% (15/43), compared with 40.3% (23/57) in the control group, according to the ASEPSIS score (P = .678). In the bilateral group (n = 7), the SSI rate was 14.3% (1/7) in the iNPWT group compared with 14.3% (1/7) in the control group (P = 1.00). In the unilateral group, there was a higher wound dehiscence rate in the control group (43.9%) compared with the iNPWT group (23.3%) (P = .0366). No serious iNPWT-related adverse events were recorded. Conclusions: There was no reduction of SSI rates in leg incisions with iNPWT compared with standard dressings in patients undergoing elective lower extremity bypass, whereas iNPWT reduced the incidence of wound dehiscence.

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author
; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Incisional negative pressure wound therapy, Lower extremity bypass, Surgical site infection, Wound dehiscence
in
Journal of Vascular Surgery
volume
79
issue
4
pages
4 - 940
publisher
Mosby-Elsevier
external identifiers
  • scopus:85181232243
  • pmid:38042513
ISSN
0741-5214
DOI
10.1016/j.jvs.2023.11.043
language
English
LU publication?
yes
id
1e24c005-3c06-4522-ac10-27f19a44b182
date added to LUP
2024-02-08 16:13:57
date last changed
2024-12-20 00:08:48
@article{1e24c005-3c06-4522-ac10-27f19a44b182,
  abstract     = {{<p>Objective: Incisional negative pressure wound therapy (iNPWT) applied over all incisions after lower extremity bypass in the prevention of surgical site infections (SSIs) is unclear. The primary and secondary aims of this study were to investigate if prophylactic iNPWT after the elective lower extremity bypass prevents SSI and other surgical wound complications. Methods: This was a multicenter, parallel, randomized controlled trial. Patients undergoing elective lower extremity bypass in 3 hospitals were randomized to either iNPWT or standard dressings. SSIs or other wound complications were assessed within the first 90 days by wound care professionals blinded to the randomized result. The validated Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay (ASEPSIS) score was used to objectively assess the wounds. ASEPSIS score ≥21 is defined as an SSI. Unilateral and bilateral groups were analyzed with the Fisher exact test and the McNemar test, respectively. Results: In the unilateral group (n = 100), the incidence of SSI in the iNPWT group was 34.9% (15/43), compared with 40.3% (23/57) in the control group, according to the ASEPSIS score (P = .678). In the bilateral group (n = 7), the SSI rate was 14.3% (1/7) in the iNPWT group compared with 14.3% (1/7) in the control group (P = 1.00). In the unilateral group, there was a higher wound dehiscence rate in the control group (43.9%) compared with the iNPWT group (23.3%) (P = .0366). No serious iNPWT-related adverse events were recorded. Conclusions: There was no reduction of SSI rates in leg incisions with iNPWT compared with standard dressings in patients undergoing elective lower extremity bypass, whereas iNPWT reduced the incidence of wound dehiscence.</p>}},
  author       = {{Rezk, Francis and Åstrand, Håkan and Svensson-Björk, Robert and Hasselmann, Julien and Nyman, Johan and Butt, Talha and Bilos, Linda and Pirouzram, Artai and Acosta, Stefan}},
  issn         = {{0741-5214}},
  keywords     = {{Incisional negative pressure wound therapy; Lower extremity bypass; Surgical site infection; Wound dehiscence}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{4--940}},
  publisher    = {{Mosby-Elsevier}},
  series       = {{Journal of Vascular Surgery}},
  title        = {{Multicenter parallel randomized trial evaluating incisional negative pressure wound therapy for the prevention of surgical site infection after lower extremity bypass}},
  url          = {{http://dx.doi.org/10.1016/j.jvs.2023.11.043}},
  doi          = {{10.1016/j.jvs.2023.11.043}},
  volume       = {{79}},
  year         = {{2024}},
}