PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair: Protocol for a multicenter randomized trial (PROPRESS study)

Negative Pressure Therapy in closed incisions (ciNPT) after surgery has shown positive effects including reduction of Surgical Site Infection (SSI) incidence. In patients undergoing elective open incisional hernia repair, however, ciNPT is not standard care, perhaps due to high-quality evidence stil...

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Bibliographic Details
Published in:Contemporary clinical trials communications 2024-04, Vol.38, p.101256, Article 101256
Main Authors: Marckmann, Mads, Henriksen, Nadia A., Krarup, Peter-Martin, Helgstrand, Frederik, Vester-Glowinski, Peter, Christoffersen, Mette Willaume, Jensen, Kristian Kiim
Format: Article
Language:English
Subjects:
Closed incision negative pressure therapy (ciNPT)
Incisional hernia
Open hernia repair
Quality-of-life
Surgical site infection
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Summary:Negative Pressure Therapy in closed incisions (ciNPT) after surgery has shown positive effects including reduction of Surgical Site Infection (SSI) incidence. In patients undergoing elective open incisional hernia repair, however, ciNPT is not standard care, perhaps due to high-quality evidence still not provided. This study hypothesizes that this patient group would benefit from ciNPT by reducing wound complications and improving postoperative quality of life. This is a multicenter Randomized Controlled Trial (RCT) including a total of 110 patients allocated in a 1:1 ratio with one intervention arm and one active control arm receiving ciNPT (i.e., Prevena™) and standard wound dressing, respectively. The primary outcome is the incidence of SSI at 30 days postoperatively and secondary outcomes are 1) pooled incidence of Surgical Site Occurrence (SSO), 2) patient-reported pain and satisfaction with the scar, and 3) hernia-related quality of life. Patients undergoing elective open incisional hernia repair are fragile with a high risk of wound complication development. This multicenter RCT seeks to deliver the high-quality evidence needed to establish the role ciNPT must play for exactly this group with the aim of reducing SSI incidence and health economic costs, and finally improving quality of life. There are no theoretical or clinical experience of unwanted consequences of this treatment.
ISSN:2451-8654
2451-8654
DOI:10.1016/j.conctc.2024.101256