Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis
NCT ID: NCT01115153
Last Updated: 2011-08-23
Study Results
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Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2007-12-31
2010-02-28
Brief Summary
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Detailed Description
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Materials and Methods: From December 2007 to November 2009, 799 patients went through surgery after being diagnosed with acute appendicitis. Out of this set, 150 patients diagnosed with acute gangrenous appendicitis, were randomly assigned to one of two groups: control group (group A: 72 patients received a 5-day antibiotic therapy), and treatment group (group B: 78 patients received a single 1-dose of antibiotic prophylaxis). The experimental outcomes included: the incidence of infection of the surgical wound, the length of the hospital stay, and the adverse effects derived from a prolonged use of antibiotics.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Antibiotic prophylaxis
Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery)
prophylaxis
single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV
Antibiotic treatment, wound infection
Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery)
therapy
antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day
Interventions
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prophylaxis
single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV
therapy
antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with possible immunosuppression such as diabetes, cancer, kidney failure, liver failure
* Pregnancy
* Patients who have received antibiotic treatment within seven days before surgery
* Patients difficult to monitor or follow up
12 Years
65 Years
ALL
No
Sponsors
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Hospital Universitario de Santander
UNKNOWN
Universidad Industrial de Santander
OTHER
Responsible Party
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Henry Uscategui Cristancho
General Surgeon
Principal Investigators
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Henry A Uscategui, Physician
Role: PRINCIPAL_INVESTIGATOR
Universidad Industrial de Santander
Francisco Camacho, Physician
Role: STUDY_DIRECTOR
Universidad Industrial de Santander
Locations
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Hospital Universitario de Santander
Bucaramanga, Santander Department, Colombia
Countries
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References
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Ein SH, Sandler A. Wound infection prophylaxis in pediatric acute appendicitis: a 26-year prospective study. J Pediatr Surg. 2006 Mar;41(3):538-41. doi: 10.1016/j.jpedsurg.2005.11.052.
Gollin G, Abarbanell A, Moores D. Oral antibiotics in the management of perforated appendicitis in children. Am Surg. 2002 Dec;68(12):1072-4.
Bauer T, Vennits B, Holm B, Hahn-Pedersen J, Lysen D, Galatius H, Kristensen ES, Graversen P, Wilhelmsen F, Skjoldborg H, et al. Antibiotic prophylaxis in acute nonperforated appendicitis. The Danish Multicenter Study Group III. Ann Surg. 1989 Mar;209(3):307-11. doi: 10.1097/00000658-198903000-00010.
Rucinski J, Fabian T, Panagopoulos G, Schein M, Wise L. Gangrenous and perforated appendicitis: a meta-analytic study of 2532 patients indicates that the incision should be closed primarily. Surgery. 2000 Feb;127(2):136-41. doi: 10.1067/msy.2000.101151.
Lemieur TP, Rodriguez JL, Jacobs DM, Bennett ME, West MA. Wound management in perforated appendicitis. Am Surg. 1999 May;65(5):439-43.
Taylor E, Berjis A, Bosch T, Hoehne F, Ozaeta M. The efficacy of postoperative oral antibiotics in appendicitis: a randomized prospective double-blinded study. Am Surg. 2004 Oct;70(10):858-62.
Page CP, Bohnen JM, Fletcher JR, McManus AT, Solomkin JS, Wittmann DH. Antimicrobial prophylaxis for surgical wounds. Guidelines for clinical care. Arch Surg. 1993 Jan;128(1):79-88. doi: 10.1001/archsurg.1993.01420130087014.
Gorecki WJ, Grochowski JA. Are antibiotics necessary in nonperforated appendicitis in children? A double blind randomized controlled trial. Med Sci Monit. 2001 Mar-Apr;7(2):289-92.
Andersen BR, Kallehave FL, Andersen HK. Antibiotics versus placebo for prevention of postoperative infection after appendicectomy. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD001439. doi: 10.1002/14651858.CD001439.pub2.
Mui LM, Ng CS, Wong SK, Lam YH, Fung TM, Fok KL, Chung SS, Ng EK. Optimum duration of prophylactic antibiotics in acute non-perforated appendicitis. ANZ J Surg. 2005 Jun;75(6):425-8. doi: 10.1111/j.1445-2197.2005.03397.x.
Snelling CM, Poenaru D, Drover JW. Minimum postoperative antibiotic duration in advanced appendicitis in children: a review. Pediatr Surg Int. 2004 Dec;20(11-12):838-45. doi: 10.1007/s00383-004-1280-x. Epub 2004 Oct 6.
Gleisner AL, Argenta R, Pimentel M, Simon TK, Jungblut CF, Petteffi L, de Souza RM, Sauerssig M, Kruel CD, Machado AR. Infective complications according to duration of antibiotic treatment in acute abdomen. Int J Infect Dis. 2004 May;8(3):155-62. doi: 10.1016/j.ijid.2003.06.003.
Hoelzer DJ, Zabel DD, Zern JT. Determining duration of antibiotic use in children with complicated appendicitis. Pediatr Infect Dis J. 1999 Nov;18(11):979-82. doi: 10.1097/00006454-199911000-00009.
Almqvist P, Leandoer L, Tornqvist A. Timing of antibiotic treatment in non-perforated gangrenous appendicitis. Eur J Surg. 1995 Jun;161(6):431-3.
Other Identifiers
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74186942
Identifier Type: -
Identifier Source: org_study_id
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