| Primary | Percentage of Participants With Pre-surgical Morbidities | Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared [BMI kg/m2]) greater than (>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin [Hb] less than (>) 9 grams per deciliter [gr/dL]) or malnutrition (hypoalbuminemia). | Study population: participants with or without SSI after surgery, treated in major hospitals with general surgical units located in Spain | Posted | | Number | | percentage of participants | | Baseline (Pre-surgical) | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. | | OG001 | Control | Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery. |
| | | Title | Denominators | Categories |
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| Neoplasm | | | | Tobacco use | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | 0.881 | | | | | | 2-Sided | | | | | | | No | Superiority or Other | | | | | Chi-squared |
|
| Primary | Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis | | | Posted | | Number | | Percentage of participants | | Baseline (Pre-surgical) | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. | | OG001 | Control | Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery. |
| |
| Primary | Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery | | | Posted | | Number | | Percentage of participants | | Day 0 (day of surgery) | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. | | OG001 | Control | Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery. |
| |
| Primary | Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty | Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin. Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds. Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old. | | Posted | | Number | | Percentage of participants | | Day 0 (day of surgery) | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. | | OG001 | Control | Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery. |
| |
| Primary | Type of Surgeon | Surgical speciality of physician who performed surgery. | | Posted | | Number | | surgeon | | Day 0 (day of surgery) | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. | | OG001 | Control | Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery. |
| |
| Primary | Percentage of Participants With Infection | Microorganism infection by bacterial type. | Subset of study population with infection; N=number of participants with evaluable data | Posted | | Number | | Percentage of participants | | Day 0 (day of surgery) up to 30 days post surgery | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. |
| |
| Primary | Percentage of Participants Who Showed Clinical Improvement of SSI | Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs). | Subset of study population with infection; N=number of participants with evaluable data | Posted | | Number | | Percentage of participants | | Day 0 (day of surgery) up to 30 days post surgery | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. |
| |
| Primary | Percentage of Participants With Post-surgical Drainage | | | Posted | | Number | | Percentage of participants | | Day 0 (day of surgery) up to 30 days post surgery | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. | | OG001 | Control | Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery. |
| |
| Secondary | Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0 | Percentage of participants with NNISS score for increased preoperative risk of infection. | | Posted | | Number | | Percentage of participants | | Baseline (pre-surgical) | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. | | OG001 | Control | Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery. |
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| Secondary | ASEPSIS Classification in Participants With Serious SSI | Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay in hospital prolonged over 14 days (ASEPSIS). ASEPSIS classification is a numerical indication of wound healing progress: satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (20-30), moderate wound infection (30-40), and severe wound infection (over 40). | Subset of study population with infection | Posted | | Number | | participants | | Up to 30 days post surgery | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. |
| |
| Secondary | Classification of SSI Infection | Participants with organ-space or deep incisional SSI. | Subset of study population with infection; N=number of participants with evaluable data | Posted | | Number | | participants | | Day 0 (day of surgery) up to 30 days post surgery | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. |
| |
| Secondary | Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics) | Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued). | Subset of study population with infection; N=number of participants with evaluable data | Posted | | Number | | Percentage of participants | | Day 0 (day of surgery) up to 30 days post surgery | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. |
| |
| Secondary | Number of Participants With Antimicrobial Resistance | Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%). | Subset of study population with infection; N=number of participants with evaluable data | Posted | | Number | | Number of participants | | Day 0 (day of surgery) up to 30 days post surgery | | | | ID | Title | Description |
|---|
| OG000 | Case | Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days. |
| |