Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

GHERT, M.; BHANDARI, M.; DEHESHI, B.; GUYATT, G.; HOLT, G.; O'SHEA, T.; RANDALL, R. L.; THABANE, L.; WUNDER, J.; EVANIEW, N.; MCKAY, P.; SCHNEIDER, P.; TURCOTTE, R.; MADDEN, K.; SCOTT, T.; SPRAGUE, S.; SIMUNOVIC, N.; SWINTON, M.; RACANO, A.; HEELS-ANSDELL, D.; BUCKINGHAM, L.; ROSE, P.; BRIGMAN, B.; PULLENAYEGUM, E.; SOBHI, G.; CHAN, R.; BILJAN, M.; FERGUSON, P.; GRIFFIN, A.; MANTAS, I.; WYLIE, A.; HAN, A.; GREWAL, G.; GOULDING, K.; DANDACHLI, F.; MATTE, G.; WERIER, J.; ABDELBARY, H.; PAQUIN, K.; COSGROVE, H.; DUGAL, A-M.; FETZER, S.; AIKENS, W.; CLARKSON, P.; WANG, B.; KONDO, L.; YIP, J.; ISLER, M.; MOTTARD, S.; BARRY, J.; YVES, H. St; QUACH, M.; ASSAYAG, H.; DAOUST, K.; GOYETTE, K.; PROJEAN, D.; DION, N.; ARTEAU, A.; TURMEL, S.; BERTRAND, A.; GAGNON, N.; LABBE, V.; HALPERN, J.; SCHWARTZ, H.; ATKINSON, A.; DANIELS, J.; MOORE, M. S.; ANDERSON, M.; GEBHARDT, M.; WAGNER, K.; PATEL, H.; JOLIN, H.; ALLAR, B.; NAQVI, M.; BENNETT, J.; ALBUQUERQUE, S.; JONES, K.; CRABTREE, S.; DAVIS, R.; SORENSON, S.; HEALEY, J. H.; GALLE, J.; O'NEILL, G.; CORRAL, B. Del; LOPEZ, S.; SERRA, M. Galli; PARIZZIA, W.; PODRZAJ, A.; TORRES, M. Foa; CLAYER, M.; CHAI, Y.; SLOBODIAN, P.; BALACH, T.; COYLE, K.; LACASSE, R.; ABRAHAM, J.; MORRISON, T.; ANGELOS, M.; SAILOR, L.; SADAKA, R.; MILLER, B.; MILHEM, M.; MCCURDY, N.; KAIN, J.; NOHR, J.; JOHNSON, K.; MERRISS, A.; CHENG, E.; LUKE, D. G.; SCHARSCHMIDT, T. J.; CRIST, M. K.; DIMEO, A.; MARMON, L.; REIMER, N.; MONSON, D.; OSKOUEI, S.; LOMBA, C.; ROGERS, S.; AVEDIAN, R.; JORDAN, L.; CHINN, S.; HAMILTON, M.; BIL-JAN, M.; YVES, H. St.; GOYETTE, Kristine; TRAN, N.; GELLER, D.; HOANG, B.; TINGLING, J.; SOLORZANO, C.; PULOSKI, S.; MONUMENT, M.; CARCARY, K.; CAMERON, C.; ABOULAFIA, A.; LOO-MIS, M.; BOSLEY, J.; BONVEGNA, R.; KASSA, M.; DAMRON, T.; CRAIG, T.; REALE, M.; GOODMAN, H. J.; CULBERTSON, M. Deza; CARUSO, P.; GARLING, E.; SCHWAB, J.; FIORE, A.; PHUKAN, R.; PARK, C.; JOSHI, L.; WALLACE, M.; FLACK, J.; VAUGHAN, K.; AVERGAS, A.; BRADY, M.; BROWN, S.; SCHADIE, N.; BATTERSBY, R.; WEISS, K.; GOODMAN, M.; HEYL, A.; YESCHKE, C. A.; SUMIC, P.; DUDGEON, M.; PROSSER, R.; KORENOSKI, C.; DICAPRIO, M.; PALMER, B.; CIOPPA, E.; SCHAEFFER, T. M.; PAUL, P.; TORESON, J.; CUMMINGS, J.; SCHWARTZ, L.; ZAHNER, B.; MORRIS, C.; LALJANI, V.; MESKO, N.; JOYCE, M.; LIETMAN, S.; WUSTRACK, R.; O'DONNELL, R.; STEVENSON, C.; CARMODY, E.; TYLER, W.; MCINTYRE, A.; SPIGUEL, A.; SCARBOROUGH, M.; GIBBS, C. P.; STESHYN, J.; NUNN, B.; ROSENTHAL, H.; HAYNES, K.; LEDDY, L.; WALTON, Z.; DOUNG, Y-C.; HAYDEN, J.; VELEZ, R.; AGUIRRE, M.; PEREZ, M.; BARRERA, S.; LOPEZ, A. Garca; GRIMER, R.; DUNN, K.; VIRDEE, H.; RANKIN, K.; BECKINGSALE, T.; GERRAND, C.; CAMPBELL, I.; ALLEN, M.; KHAN, S. Alam; BAKSHI, S.; RASTOGI, S.; POUDEL, R.; KUMAR, V. Sampath; RAI, A.; BAPTISTA, A. M.; CAMARGO, O. P. de; MARAIS, L.; RODSETH, R.; FERREIRA, N.; RAJAH, C.; GUMEDE, S.; GORTZAK, Y.; STERNHEIM, A.; BICKELS, J.; KOLANDER, Y.; LEV, S.; HETTWER, W.; PETERSEN, M. M.; GRUM-SCHWENSEN, T.; JUTTE, P.; PLOEGMAKERS, J. J. W.; STEVENS, M.; MAHENDRA, A.; GUPTA, S.; BERGOVEC, M.; LEITHNER, A.; FUNOVICS, P.; DIJKSTRA, P. D. S.; SANDE, M. Van De; HOOGENSTRAATEN, A.; LEIJERZAPF, N.; STEADMAN, P.; BOFFANO, M.; PIANA, R.; MARONE, S.; ALBERTINI, U.; BOUX, E.; MAIELLO, A.; REPSA, L.; ZILE, S.; ASTON, W.; POLLOCK, R.; COOL, P.; GIBBONS, M.; WHIT-WELL, D.; COSKER, T.; HEMINGWAY, J.; PORTER, D.; PATTON, S.; NAVIA, J.; BETANCUR, A. F.; LAITENEN, M.; PAKARINEN, K.; NIEMINEN, J.; YLA-MONONEN, S.; RAUTIAINEN, S.; FIORENZA, F.

Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

Arquivos

art_GHERT_Prophylactic_antibiotic_regimens_in_tumour_surgery_PARITY_A_2015.PDF (252.05 KB)

Citações na Scopus

25

Tipo de produção

article

Data de publicação

2015

DOI

Scopus

Web of Science

PubMed

Editora

BRITISH EDITORIAL SOC BONE JOINT SURGERY

Autores

GHERT, M.

BHANDARI, M.

DEHESHI, B.

GUYATT, G.

HOLT, G.

O'SHEA, T.

RANDALL, R. L.

THABANE, L.

WUNDER, J.

EVANIEW, N.

Citação

BONE & JOINT RESEARCH, v.4, n.9, p.154-162, 2015

Resumo

Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-day regimen of post-operative antibiotics, in comparison to a 24-hour regimen, decreases surgical site infections in patients undergoing endoprosthetic reconstruction for lower extremity primary bone tumours. Methods We performed a pilot international multi-centre RCT. We used central randomisation to conceal treatment allocation and sham antibiotics to blind participants, surgeons, and data collectors. We determined feasibility by measuring patient enrolment, completeness of follow-up, and protocol deviations for the antibiotic regimens. Results We screened 96 patients and enrolled 60 participants (44 men and 16 women) across 21 sites from four countries over 24 months (mean 2.13 participants per site per year, standard deviation 2.14). One participant was lost to follow-up and one withdrew consent. Complete data were obtained for 98% of eligible patients at two weeks, 83% at six months, and 73% at one year (the remainder with partial data or pending queries). In total, 18 participants missed at least one dose of antibiotics or placebo post-operatively, but 93% of all postoperative doses were administered per protocol. Conclusions It is feasible to conduct a definitive multi-centre RCT of post-operative antibiotic regimens in patients with bone sarcomas, but further expansion of our collaborative network will be critical. We have demonstrated an ability to coordinate in multiple countries, enrol participants, maintain protocol adherence, and minimise losses to follow-up.

Palavras-chave

Orthopaedic oncology, bone sarcoma, randomised controlled trials, antibiotics, pilot study

URI

https://observatorio.fm.usp.br/handle/OPI/12747

Referências

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Coleções

Artigos e Materiais de Revistas Científicas - FM/MOT
Artigos e Materiais de Revistas Científicas - HC/IOT
Artigos e Materiais de Revistas Científicas - LIM/41
Artigos e Materiais de Revistas Científicas - ODS/03

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