NCT05523713: SPRED

Development and Validation of a Predictive Score for Surgical Site Infections

Completed NA Last updated 13 March 2025

What this trial tests

NA trial testing Peripheral venous blood samples in Colon or Colorectal Resection in 283 participants. Completed in 27 January 2025.

Timeline

6 October 2022

Primary endpoint
29 November 2023

27 January 2025

Quick facts

Lead sponsor	Hopital Foch
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	283
Start date	6 October 2022
Primary completion	29 November 2023
Estimated completion	27 January 2025
Sites	4 locations across France

Drugs / interventions tested

• Peripheral venous blood samples — full drug profile →

Conditions studied

• Colon or Colorectal Resection — all drugs for Colon or Colorectal Resection →
• Partial or Total Gastrectomy — all drugs for Partial or Total Gastrectomy →
• Pancreaticoduodenectomy — all drugs for Pancreaticoduodenectomy →
• Hepatectomy — all drugs for Hepatectomy →

Sponsor

Hopital Foch — full company profile →

Who can join

Adults 18 to 99, any sex, with Colon or Colorectal Resection or Partial or Total Gastrectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

More than 8 millions surgical interventions are carried out each year in France. Postoperative complications, in particular infectious, can occur in 10 to 60% of cases and are the cause of postoperative revision in 30% of cases, an increase in mortality, length of stay, readmissions and lead to significant additional socio-economic costs. Currently, improvements in surgical practices have not reduced the incidence of surgical site complications. In this context, the development of predictive scores for the risk of post-operative complication becomes urgent in order to implement new interventions (pre-habilitation) or to modify surgical decisions (timing, approach) in order to reduce the risk of complications before surgery. Several recent studies highlights the importance of the immune response in postoperative prognosis. In particular, an imbalance between the adaptive and innate response involving MDSCs has been demonstrated in patients with postoperative complications.Thanks to new techniques for analyzing the immune system, in-depth analysis of the immune system before surgery is a very promising approach aimed at identifying predictive biomarkers of postoperative prognosis.

Our team has developed and patented a multivariate model integrating mass cytometry data, proteomics and clinical data collected before surgery to accurately predict the occurrence of a surgical site complication (AUC = 0.94, p\<10e-7) in a monocentric cohort of 43 patients to major abdominal surgery (Stanford University).

The objective of the present study is to generalize and validate this preoperative predictive score of infectious complications of the surgical site in the 30 days following major digestive surgery on a larger workforce within a multicenter cohort and to validate this score at using a machine learning method.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of postoperative complications on cost and length of stay: multicentre prospective clinical study.
   Hedou J, Mendes G, Bellan G, El Khoury D, et al · · 2025 · PMID 41544044 · DOI 10.1093/bjs/znaf290