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| Name | Class |
|---|---|
| Hospital Universitario de Santander | UNKNOWN |
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A prospective, randomized controlled clinical trial was conducted at the Hospital Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous appendicitis.
Introduction: For patients with acute gangrenous appendicitis, it is common to provide antibiotics during 5-7 days in order to reduce the incidence of infection of the surgical wound; however the benefit of such treatment has not been tested. A prospective, randomized controlled clinical trial was conducted at the Hospital Universitario de Santander to test the effectiveness of providing a single 1-dose therapy of antibiotic prophylaxis versus a 5-day antibiotic therapy in patients with acute gangrenous appendicitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic prophylaxis | Experimental | Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery) |
|
| Antibiotic treatment, wound infection | Active Comparator | Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prophylaxis | Other | single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| wound infection | Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of the hospital stay | Duration in days from admission until discharge | 30 days |
| Adverse effects treatment related | Adverse effects derived from the usage of antibiotics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry A Uscategui, Physician | Universidad Industrial de Santander | Principal Investigator |
| Francisco Camacho, Physician | Universidad Industrial de Santander | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Santander | Bucaramanga | Santander Department | 097 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16516631 | Background | 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. | |
| 12516811 | Background | Gollin G, Abarbanell A, Moores D. Oral antibiotics in the management of perforated appendicitis in children. Am Surg. 2002 Dec;68(12):1072-4. |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D014946 | Wound Infection |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| therapy | Other | antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day |
|
| 30 days |
| 2647050 | Background | 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. |
| 10686977 | Result | 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. |
| 10231213 | Result | Lemieur TP, Rodriguez JL, Jacobs DM, Bennett ME, West MA. Wound management in perforated appendicitis. Am Surg. 1999 May;65(5):439-43. |
| 15529837 | Result | 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. |
| 8418785 | Result | 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. |
| 11257737 | Result | 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. |
| 16034862 | Result | 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. |
| 15943731 | Result | 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. |
| 15480707 | Result | 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. |
| 15109590 | Result | 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. |
| 10571434 | Result | 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. |
| 7548380 | Result | Almqvist P, Leandoer L, Tornqvist A. Timing of antibiotic treatment in non-perforated gangrenous appendicitis. Eur J Surg. 1995 Jun;161(6):431-3. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |