Postoperative wound infections are among the most common hospital-acquired infections and represent a major medical and economic burden, causing prolonged hospital stays, additional surgeries, implant replacements, and increased healthcare costs. In orthopedic and trauma surgery, where implants are frequently used, even minimal bacterial contamination during surgery can result in severe and difficult-to-treat infections. However, it remains insufficiently understood when and where such contamina
Conditions
Interventions
Group 1: Prospectively investigates the spatial and temporal development of bacterial contamination in the orthopedic surgical field during musculoskeletal operations lasting over 90 minutes. Surface
Sponsors
Universitätsklinikum RWTH Aachen, Abteilung für Orthopädie, Unfall- und Wiederherstellungschirurgie, Abteilung für Endoprothetik und Tumororthopädie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: In study arm 1, adult patients undergoing orthopedic or trauma-related musculoskeletal surgery with an expected duration of at least 90 minutes will be included. Only patients without clinical or microbiological evidence of an existing infection in the surgical area are eligible. All participants must be capable of providing informed consent and must sign a written consent form prior to inclusion. In study arm 2, adult patients with an acute or chronic periprosthetic joint infection of the hip or knee who are scheduled for revision surgery including debridement and prosthesis exchange will be enrolled. As in study arm 1, participants must be able to provide informed consent and give written authorization to participate in the study.
Exclusion criteria
Exclusion criteria: In study arm 1, patients will be excluded if there is a pre-existing infection in the surgical area or if the procedure is performed for a septic indication. Further exclusion criteria include an expected surgical duration of less than 90 minutes, systemic infection (e.g., sepsis), use of experimental or non-standardized surgical techniques, lack of capacity to provide informed consent, or absence of written consent. In study arm 2, exclusion criteria are the absence of a confirmed periprosthetic infection or a revision procedure performed for aseptic reasons only. Patients who are unable to provide informed consent or do not sign the consent form are also excluded. Additional exclusion criteria include a general health condition or comorbidities that preclude safe intraoperative sampling, as well as situations in which postoperative follow-up cannot be reliably ensured.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For arm 1 the primary endpoint is the change in bacterial contamination rate of the surgical field over time. Sampling is performed at the beginning of surgery (before incision) and every 30 minutes thereafter until just before wound closure using standardized RODAC contact plates at predefined sites within the surgical field. The outcome is quantified by colony-forming units (CFU) after 14 days of incubation. For arm 2 the primary endpoint is the bacterial contamination rate after renewal of surgical drapes and instruments during septic prosthesis revision surgery. Sampling is conducted twice intraoperatively: 1) At the end of the septic phase (after debridement and removal of infected tissue and prosthetic material), and 2) after renewal of drapes, gloves, gowns, instruments, and suction system, before wound closure. Colony-forming units (CFU) are quantified after 14 days of incubation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study include, in study arm 1, the correlation between the degree of bacterial contamination and the occurrence of postoperative wound infections within 90 days after surgery. Furthermore, the type and frequency of bacterial species as well as their spatial distribution across the different sampling sites of the surgical field will be analyzed. An additional secondary endpoint is the long-term clinical outcome, particularly the occurrence of wound infections or implant-associated complications at the 24-month follow-up. In study arm 2, secondary endpoints comprise the reinfection rate after septic prosthesis revision surgery in comparison with published reference data, the type and frequency of bacterial species detected before and after renewal of surgical drapes and instruments, and the relationship between intraoperative reduction of bacterial contamination and the postoperative clinical course. The occurrence of reinfection at the 24-month follow-up is also defined as a secondary endpoint. | — |
Countries
Germany
Contacts
Public ContactUlf Krister Hofmann
Universitätsklinikum RWTH Aachen, Abteilung für Orthopädie, Unfall- und Wiederherstellungschirurgie, Abteilung für Endoprothetik und Tumororthopädie
Outcome results
None listed