Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Research Institutes of Sweden | OTHER |
| Göteborg University | OTHER |
| CRC Medical AB | UNKNOWN |
| Getinge AB |
Not provided
Not provided
Not provided
Not provided
In the present study we will compare bacteriological findings and the incidence of SSI in relation to laminar airflow (LAF) ventilated ORs, conventional (also called displacement or mixed) ventilated ORs and conventional ventilated ORs with the addition of tables equipped with units providing a local LAF over the surgical instruments.
The hypothesis is that there exist a correlation between number and types of airborne bacteria and bacteria in the surgical wound and on surgical instruments at the time of wound closure.
The scientific literature on the relationship between airborne bacteria and wound contamination during different conditions is scares. A study from 1982 (Whyet et al.), demonstrated that the most important and consistent source of contamination of the wound during clean surgery (in this case hip implant surgery) was via air. The study concluded that approximately one third of bacteria in the wound were caused by direct air contamination whereas the remaining number of bacteria were transferred to the wound by indirect routes such as via contaminated instruments.
The present study includes patients undergoing hemiarthroplastic surgery due to hip fracture.
During the surgery active air sampling, for microbial analysis, will be done within 30 cm from the wound.
Passive sampling of instrument tables, to measure number of depositing bacteria on the surface during the procedure, will be performed by placing sterile filters on the table surfaces before initiating the surgical procedure and collecting them at the end.
Skin and wound sampling will be performed with sterile flocked nylon swabs. The method for skin and wound sampling was decided based on a literature review and discussions with the department of Clinical microbiology at Sahlgrenska University hospital. Both aerobe and anaerobe bacteria will be analyzed.
The wound will be measured and number of personnel, door openings and clothing, at each procedure will be recorded.
Patients included in the study will be interviewed after 6 weeks and 1 year, to evaluate incidence rate of SSI.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemiarthroplasty | Hip fracture patients operated with hemiarthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional ventilation + instrumental tables with integrated laminar airflow | Device | Surgical instruments protected from contamination by local laminar airflow |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live bacterial Count (colony forming units, CFU) per meter3 air during surgery; in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | Active airsampling within 30cm from the surgical wound will be performed during surgery and number of collected aerobe and anaerobe bacteria analyzed. | 2019-2021 |
| Number of CFU in the surgical wound before closure; after surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | The entire wound is swabed before closure, aerobe and anaerobe bacteria analyzed. | 2019-2021 |
| Measure | Description | Time Frame |
|---|---|---|
| CFU/dm2 on the patients skin Before directly prior to incission, before surgery in surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | Swab sample is taken of the skin directly prior to incission, aerobe and anaerobe bacteria analyzed. | 2019-2022 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Hip fracture patients operated with hemiarthroplasty
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annette Erichsen Andersson | Contact | +46 73 725 04 58 | annette.erichsen.andersson@gu.se | |
| Henrik Malchau | Contact | +46 70 820 76 51 | henrik.malchau@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Henrik Malchau | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ortopedics, Sahlgrenska University Hospital | Recruiting | Mölndal | 43180 | Sweden |
Not provided
| UNKNOWN |
| Toul Meditech AB | UNKNOWN |
| Halmstad University | OTHER |
Not provided
Not provided
Not provided
Swab samples for microbial analysis. Samples taken from skin before surgery and from surgical wound before closure.
| Conventional ventilation + standard instrumental tables | Device | Control |
|
| Laminar airflow ventilation + standard instrumental tables | Device | Control |
|
| CFU/dm2 on the instrument tables during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables |
Passive sampling of bacteria falling down on the instrument tables during the duration of each surgical procedure will be analyzed. Aerobe and anaerobe bacteria analyzed. |
| 2019-2022 |
| Bacterial species in air collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | The bacterial species in collected samples are identified with MALDI-TOF | 2019-2022 |
| Bacterial species in wound samples collected during surgery in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | The bacterial species in collected samples are identified with MALDI-TOF | 2019-2022 |
| Number and sort of SSI in patients operated in ORs with LAF ventilation, Conventional ventilation or Conventional ventilation + local LAF above instrument tables | Patients are contacted 6 weeks and 1 year after surgery and incidense and severrensess of infection recorded | 2019-2022 |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D006620 | Hip Fractures |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided