Skip to main content

Table 6 Study outcomes by treatment group

From: Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): a multi-center randomized controlled study comparing alternative antibiotic regimens in patients undergoing tumor resections with endoprosthetic replacements—a statistical analysis plan

Study endpoint

Treatment X

N = XXX

n (%)

Treatment Y

N = XXX

n (%)

Hazard ratio (95% CI)

p value

Primary outcome

 Any surgical site infection

  Superficial incisional

    

  Deep incisional

    

  Organ/space

Secondary outcomes

 Any antibiotic-related complication

  Stomach cramps

    

  Nausea/vomiting

    

  Oral candidiasis

    

  Unusual bleeding/bruising

    

  Difficulty breathing

    

  Sore mouth/throat

    

  Allergic reaction (itching, drug fever, skin rash, anaphylaxis)

    

  Anemia/low blood counts

    

  Skin reaction

    

  Diarrhea

    

  Liver toxicity

    

  Kidney toxicity

    

  Clostridioides difficile-associated colitis

    

  Toxic megacolon

    

  Opportunistic fungal infection

    

  Indwelling catheter-related sepsis

    

  Other antibiotic-related events

    

 Any unplanned re-operation

  Implant revision

    

  Irrigation and debridement

    

  Wound flap

    

  Skin graft

    

  Bone graft

    

  Implant exchange

    

  Extensor mechanism reconstruction

    

  Repeat tumor excision

    

  Antibiotic spacer insertion

    

  Patellar reconstruction

    

  Abductor reconstruction

    

  Rotationplasty

    

  Amputation

    

  Other unplanned re-operations

    

 Any oncologic event

  Local recurrence

    

  Distant metastases

    

 Mortality due to any cause

  Mortality due to disease progression