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Table 4 Surgical and peri-operative management details

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

Characteristic

Treatment X

N = XXX

Treatment Y

N = XXX

Surgical details

 Length of procedure [min], mean (SD)

  

 Type of skin sterilization, n (%)

  Iodine

  

  Alcohol

  

  Others (specify)

  

 Length of incision [cm], mean (SD)

  

 Laminar flow, n (%)

  No

  

  Yes

  

 Spacesuit worn, n (%)

  No

  

  Yes

  

 Type of resection, n (%)

  Intra-articular

  

  Extra-articular

  

 Length of bone resected, n (%)

  < 5 cm

  

  5–10 cm

  

  > 10 cm

  

 Skin excised, n (%)

  None

  

  Small (< 5 cm2)

  

  Moderate (5–10 cm2)

  

  Large (> 10 cm2)

  

 Muscle excised, n (%)

  Small (< 50 cm3)

  

  Moderate (50–100 cm3)

  

  Large (> 100 cm3)

  

 Fascial tissue excised, n (%)

  None

  

  Small (< 1 cm2)

  

  Moderate (1–5 cm2)

  

  Large (> 5 cm2)

  

 Type of fixation, n (%)

  Press-fit

  

  Cement

  

   With antibiotic

  

   Without antibiotic

  

  Cerclage

  

   Wire

  

   Cable

  

   Synthetic

  

 Bone grafting performed, n (%)

  No

  

  Yes

  

   Synthetic bone graft

  

   Autograft

  

    Cortical

  

    Cancellous

  

    Vascularized cancellous

  

   Allograft

  

    Cortical

  

    Cancellous

  

 Vascular reconstruction, n (%)

  No

  

  Yes

  

   < 5 cm

  

   5–10 cm

  

   > 10 cm

  

 Intra-operative prophylaxis, n (%)

  No

  

  Yes

  

   IV heparin

  

   Tranexamic acid

  

   Others (specify)

  

 Antibiotic or silver-coated prosthesis, n (%)

  No

  

  Yes

  

   Antibiotic (specify)

  

   Silver

  

 Antibiotic impregnated sponge or antibiotic powder implanted, n (%)

  No

  

  Yes

  

   Gentamicin

  

   Tobramycin

  

   Cefazolin

  

   Vancomycin

  

   Others (specify)

  

 Irrigation performed at the end of the procedure, n (%)

  No

  

  Yes, pulsed irrigation

  

  Yes, antibiotics in irrigation

  

 Mode of skin closure, n (%)

  Primary closure

  

  Local fasciocutaneous flap

  

  Local muscle flap and split

  

  Thickness skin graft

  

  Free flap

  

Peri-operative management details

 Post-operative thromboprophylaxis, n (%)

  No

  

  Yes

  

   Coumadin

  

   Heparin

  

   Fractionated heparin

  

   Oral

  

 Suction drain, n (%)

  No

  

  Yes

  

   Duration

  

 Urinary catheter, n (%)

  No

  

  Yes

  

   Duration

  

 No. of patients in a hospital room, n (%)

  1

  

  2

  

  3

  

  4

  

  > 4

  

 Time to first post-operative wound dressing change [days], mean (SD)

  

 Negative-pressure wound therapy (wound vac), n (%)

  No

  

  Yes

  

   Duration

  

 Length of post-operative hospital stay [days], mean (SD)

  

 Discharge location, n (%)

  

  Home

  

  Rehabilitation facility

  

  Other hospitals

  

  Others (specify)