Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 May;106(5):418-424.
doi: 10.1308/rcsann.2023.0011. Epub 2023 Jul 12.

Effectiveness of incisional negative pressure wound therapy after major lower extremity amputation: a randomised controlled trial

V V Vaddavalli  1 , B Girdhani  1 , A Savlania  1 , A Behera  1 , A Rastogi  1 , L Kaman  1 , K Abuji  1
Affiliations
Randomized Controlled Trial

Effectiveness of incisional negative pressure wound therapy after major lower extremity amputation: a randomised controlled trial

V V Vaddavalli et al. Ann R Coll Surg Engl. 2024 May.

Abstract

Introduction: The aim was to study the effect of incisional negative pressure wound therapy (iNPWT) in wound healing compared with standard sterile gauze dressings after major lower extremity amputation in patients with peripheral arterial disease (PAD).

Methods: This prospective, randomised controlled trial included 50 patients undergoing major lower extremity amputations for PAD. Patients were randomised into iNPWT and standard dressing groups. The patency of blood vessels at the level of the stump was ensured with or without revascularisation. The primary outcome was wound-related complications such as surgical site infection (SSI), wound dehiscence, seroma/haematoma formation or the need for revision amputation. The secondary outcome was the time taken for the eligibility of prosthesis placement.

Results: It was found that only 12% of the patients in the iNPWT group had SSI compared with 36% in the standard dressing group (p = 0.047). Rates of wound dehiscence, seroma/haematoma formation and revision amputation were decreased in the iNPWT group but this was not statistically significant (p > 0.05). There was a significant reduction in the time taken for eligibility of prosthesis placement in the iNPWT group (5.12 ± 1.53 vs 6.8 ± 1.95 weeks, p = 0.002).

Conclusions: iNPWT is effective in reducing the incidence of SSI and the time taken for rehabilitation in patients undergoing major lower limb amputation due to PAD.

Keywords: Amputation; PAD; RCT; Stump dehiscence; Surgical site infection; iNPWT.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow chart showing the study design
Figure 2
Figure 2
Wound-related complications between incisional negative pressure wound therapy and standard dressing groups
See this image and copyright information in PMC

References

    1. Van der Meij WKN. No leg to stand on. Historical relation between amputations. Surg Prostheseol 1995; 1: 1–256.
    1. Advanced Amputee Solutions. Amputee Statistics. https://advancedamputees.com/amputee-statistics-you-ought-know (cited April 2024).
    1. Norgren L, Hiatt WR, Dormandy JAet al. . The next 10 years in the management of peripheral artery disease: perspectives from the ‘PAD 2009’Conference. Eur J Vasc Endovasc Surg 2010; 40: 375–380. - PubMed
    1. Berridge DC, Slack RC, Hopkinson BR, Makin GS. A bacteriological survey of amputation wound sepsis. J Hosp Infect 1989; 13: 167–172. - PubMed
    1. Perkins P. Surgical wounds. Wound dehiscence: causes and care. Nurs Stand Spec Suppl 1992; 34: 12–14. - PubMed

Publication types