PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair: Protocol for a multicenter randomized trial (PROPRESS study)
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PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair : Protocol for a multicenter randomized trial (PROPRESS study). / Marckmann, Mads; Henriksen, Nadia A.; Krarup, Peter Martin; Helgstrand, Frederik; Vester-Glowinski, Peter; Christoffersen, Mette Willaume; Jensen, Kristian Kiim.
In: Contemporary Clinical Trials Communications, Vol. 38, 101256, 2024.Research output: Contribution to journal › Journal article › Research › peer-review
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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 -
ID: 386361475