Research

Objectives

Quality performance of clinical therapeutic trails, according to International Conference of Harmonization Guidelines and Good Clinical Practice, South African, FDA.

Ethics Committee

The Research Unit operates under the supervision of the Committee for Research on Human Subjects of the University of the Witwatersrand. The Ethics Committee is constituted according to GCP and FDA regulations

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Our staff members are experienced in performing various aspects of clinical trials.

Contract Research

• I6424-203a. A Phase 2, Randomised, Double-blind, Parallel-group, Multinational Trial of Intravenous TD-6424 for treatment of Staphylococcus aureus Bacteremias.
• 2004 ? current
  HEM-0125 A Single-Center Study to Evaluate the Safety and Tolerability of Hemoglobin Based Oxygen Carrier-201 (HBOC-201) in Trauma Subjects (Phase II ? Safety and Tolerability)
• 2004-2004
  FG-463-21-08 ? A Multicenter, double blind, comparative, randomised study to evaluate the efficacy and safety of Micafungin (FK463) versus Liposomal Amphotericin B (Ambisome) in the treatment of invasive Candidiasis and Candidemia
• 2002-2003
  F7Trauma-2159 - A multi-centre, randomised, double-blind, parallel group, placebo controlled trial to evaluate the efficacy and safety of activated recombinant factor VII (rFVIIa/NovoSeven) in the treatment of bleeding in severely injured trauma subjects .

This unit was the lead unit for the trial

Original Research

Published /presented papers - 2001-2004:

• Boffard KD, Bybee C, Sawyer B, Ferguson L.
  The Management of Near Drowning
  Trauma 2001; 2; 269-276
• Boffard KD, Bybee C, Sawyer B, Ferguson L.
  The Management of Near Drowning
  Trauma 2001; 2; 269-276
• Boffard KD, Bybee C, Sawyer B, Ferguson L.
  The Management of Near Drowning
  J R Army Med Corps 2001; 147: 135-141
• Bowley DMG, Boffard KD
  Penetrating lung hernia with pulmonary evisceration
  J Trauma 2001; 50(3): 560-561
• Degiannis E, Khelif K, Leandros E, Boffard K and S dia R.
  Gunshot injuries of the Extrahepatic Biliary Ducts
  Eur J Surg; 2001 167: 618-621
• Degiannis E, Brink J, H gensen M, Williams P, and Boffard KD
  Rupture of the Auricle of the Right Atrium of the Heart and Pericardium after Blunt Trauma
  Eur J Surg 2001; 167:473-474
• Bowley DMG, Boffard KD, Goosen J, Bebington BD and Plani F.
  Evolving concepts in the management of colonic injury.
  Injury 2001; 32:435-439
• Degiannis E, Brink J, H genson M, Williams P, and Boffard KD.
  Rupture of the auricle of the right atrium of the heart and pericardium after blunt trauma.
  Eur. J. Surg 2001; 167:472 ? 474.
• Hersman G, Barker P, Bowley DM and Boffard KD.
  The management of penetrating neck injuries.
  Int Surg. 2001; Apr-Jun; 86(2): 82 ? 89
• Bowley DMG, Barker P and Boffard KD
  Small Bowel Evisceration: The Image of Trauma
  J Trauma 2001; 51(6); 1217
• Bowley DMG and Boffard KD
  Das penetrierende Trauma des K?rstamms (Penetrating Trauma of the torso)
  Unfallchirurg: German Trauma Journal. 2001; 104(11): 1032-1042
• Moeng MS and Boffard KD.
  Penetrating Neck Injuries
  Scandinavian J Surg 2002; 91(1): 34 ? 40
• Degiannis E and Boffard KD
  Critical Decisions in trauma of the Thoracic Aorta
  Injury. 2002; 33(4):317 - 322.
• Bowley DMG, Buchan C, Khulu L, and Boffard KD
  Acute renal failure after punishment beatings.
  J. Roy Soc Med. 2002; 95: 300 ? 301
• Bowley D, Cherry R, Snyman T, Vellema J, Rein P, Moeng S, and Boffard KD.
  Seroprevalence of the human immunodeficiency virus in major trauma patients in Johannesburg
  S Afr Med J. 2002 Oct; 92(10): 792 ? 793
• Bowley DM, Khavandi A, Boffard KD, Macnab C, Eales J, Vellema J, Schoon H, and Goosen J.
  The malignant epidemic ? changing patterns of trauma
  S Afr Med J. 2002 Oct; 92(10): 798 ? 802
• Brooks A, Bowley DM and Boffard KD.
  Bullet markers ? a simple technique to assist in the evaluation of penetrating trauma.
  J R Army Med Corps. 2002 Sep; 148(3): 259 ? 261.
• Bowley DM, Saeed M, Somwe D, Boffard KD, Naidoo K, David SC.
  Off-pump cardiac revascularization after a complex stb wound.
  Ann Thorac Surg. 2002 Dec;74(6):2192-3.
  PMID; 12643425 [PubMed ? indexed for MEDLINE]
• Bowley DM, Daeed M, Somwe D, Naidoo K, Davis S, and Boffard KD.
  Off-pump cardiac revascularisation after a complex stab wound.
  Ann Thoracic Surg. 2002; 74: 2192-2193
• Penetrating Neck injuries ? Scandanaviah Journal of Surgery 91:34-40, 2002
• Tai NR, Nielson S, Boffard KD
  Host should also protect students on electives from HIV.
  BMJ. 2003 Feb 8;326(7384):338. No abstract available.
• Bowley DM, Gordon MP, Boffard KD
  Thoracic impalement after ultralight aircraft crash.
  J Thoracic Cardiovasc Surg. 2003 Apr;125(4):954-5. No abstract available.
  PMID: 12698163 [PubMed ? indexed for MEDLINE]
• Tai NR, Boffard KD, Goosen J, Plani F.
  A 10-year experience of complex liver trauma (Br J Surg 2002; 89: 1532 ?1537)
  Br J Surg. 2003 Apr:90(4):486-7. No abstract available.
  PMID: 12673755 [PubMed ? indexed for MEDLINE]
• Bowley DM, Boffard KD
  Unrecognized coarctation of the aorta predisposes to aortic rupture after blunt trauma.
  J Trauma. 2003 Aug:55(2):372-4. No abstract available.
  PMID: 12913653 [PubMed ? indexed for MEDLINE]
• Plani F, Bowley DM, Goosen J.
  Death and injury on duty ?a study of South African police officers.
  S Sfr Med J 2003 Nov; 93(11):851
• Joshipura M, Mock C, Goosen J, Peden M.
  Essential Trauma Care: strengthening trauma care round the world.
  Injury, Int J. Care Injured (2003). In press
• Bowley DM, Rein P, Cherry R, Vellema J, Snyman T, Boffard KD.
  Substance abuse and major trauma in Johannesburg.
  S Afr J Surg. 2004 Feb; 42(1):7-10
  PMID: 15181707 [PubMed ? indexed for MEDLINE]
• Mock C, Joshipura M, Goosen J.
  Editorial: Strengthening the care of the injured globally.
  Bulletin of the World Health Organization 2004 Apr. (In press)
• Bowley DM, Parmar NK, Boffard KD
  Burdens of dideade in southern Africa.
  Lancet. 2004 May 8,363(9420):1508. No abstract available
  PMID:12913653 [PubMed ? indexed for medline]
• Goosen J, Plani F, Degiannis E.
  Trauma in South Africa. Injury