Chetter, I., Arundel, C., Martin, B.C. et al. (18 more authors) (2021) Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial) : study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial. Trials, 22 (1). 739.
Abstract
Background
The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds.
Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI.
Methods
SWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months.
The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use.
Discussion
Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI.
The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres.
Trial registration
ISRCTN 26277546. Prospectively registered on 25 March 2019
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2021 The Author(s). Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
Keywords: | Negative pressure wound therapy; Randomised controlled trial; Secondary intention; Surgical wounds; Wound healing; Adult; Humans; Intention; Multicenter Studies as Topic; Negative-Pressure Wound Therapy; Quality of Life; Randomized Controlled Trials as Topic; Surgical Wound; Surgical Wound Infection; Wound Healing |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) |
Funding Information: | Funder Grant number Medical Research Council MR/K025643/1 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 01 Sep 2022 07:28 |
Last Modified: | 02 Sep 2022 22:06 |
Status: | Published |
Publisher: | BioMed Central (part of Springer Nature) |
Refereed: | Yes |
Identification Number: | 10.1186/s13063-021-05662-2 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:190479 |