Concept of and preliminary trial protocol for adjuvant treatment of mediastinitis with immunoglobulins after cardiac surgery (ATMI): response to comments and criticism.
During the consensus-based process of protocol development external experts were invited to comment on a proposal for a trial protocol on adjuvant immunotreatment of patients with wound infection after median sternotomy (ATMI). Controversies and arguments can be divided into five main areas: 1) rationale and objectives; 2) criteria for patient selection; 3) adjuvant treatment; 4) measures of efficacy; and 5) course and timetable of the study. We present and summarise the experts comments and criticism as well as the result of the final discussion of the study group with respect to these areas.
Marggraf
G
G
Universitätsklinik, Thorax- und Kardiovaskuläre Chirurgie, Essen, Germany.
Arnold
A
A
Geiger
A
A
Gödje
O
O
Knocks
M
M
Krabatsch
T
T
Lefering
R
R
Lorenz
K
K
Neugebauer
E
E
Schmitt
D
D
Schnelle
K
K
Teebken
O
O
Tugtekin
M
M
D018806:APACHE; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D003245:Consensus Statements as Topic; D016207:Cytokines / Q000097:blood; D003646:Debridement; D004322:Drainage; D006801:Humans; D007070:Immunoglobulin A / Q000627:therapeutic use*; D007075:Immunoglobulin M / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008480:Mediastinitis / Q000628:therapy*; D018579:Patient Selection; D012107:Research Design; D018805:Sepsis / Q000628:therapy; D013249:Sternum / Q000601:surgery; D013530:Surgical Wound Infection / Q000628:therapy; D013997:Time Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D016207:Cytokines; D007070:Immunoglobulin A; D007075:Immunoglobulin M; D016756:Immunoglobulins, Intravenous; C060166:pentaglobulin