TY - JOUR

T1 - PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair

T2 - Protocol for a multicenter randomized trial (PROPRESS study)

AU - Marckmann, Mads

AU - Henriksen, Nadia A.

AU - Krarup, Peter Martin

AU - Helgstrand, Frederik

AU - Vester-Glowinski, Peter

AU - Christoffersen, Mette Willaume

AU - Jensen, Kristian Kiim

N1 - Publisher Copyright: © 2024 The Authors

PY - 2024

Y1 - 2024

N2 - Background: 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. Method: 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. Conclusion: 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.

AB - Background: 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. Method: 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. Conclusion: 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.

KW - Closed incision negative pressure therapy (ciNPT)

KW - Incisional hernia

KW - Open hernia repair

KW - Quality-of-life

KW - Surgical site infection

U2 - 10.1016/j.conctc.2024.101256

DO - 10.1016/j.conctc.2024.101256

M3 - Journal article

C2 - 38298916

AN - SCOPUS:85182756728

VL - 38

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

SN - 2451-8654

M1 - 101256

ER -