Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis
Primary Purpose
Gangrenous Appendicitis
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
prophylaxis
therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gangrenous Appendicitis focused on measuring Acute appendicitis, Antibiotic prophylaxis, Wound infection, Nosocomial infection
Eligibility Criteria
Inclusion Criteria:
- patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study
Exclusion Criteria:
- patients under 12 or older 65 years old
- 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
Sites / Locations
- Hospital Universitario de Santander
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Antibiotic prophylaxis
Antibiotic treatment, wound infection
Arm Description
Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery)
Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery)
Outcomes
Primary Outcome Measures
wound infection
Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space
Secondary Outcome Measures
Length of the hospital stay
Duration in days from admission until discharge
Adverse effects treatment related
Adverse effects derived from the usage of antibiotics
Full Information
NCT ID
NCT01115153
First Posted
April 19, 2010
Last Updated
August 22, 2011
Sponsor
Universidad Industrial de Santander
Collaborators
Hospital Universitario de Santander
1. Study Identification
Unique Protocol Identification Number
NCT01115153
Brief Title
Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis
Official Title
Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis (Randomized, Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Industrial de Santander
Collaborators
Hospital Universitario de Santander
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gangrenous Appendicitis
Keywords
Acute appendicitis, Antibiotic prophylaxis, Wound infection, Nosocomial infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic prophylaxis
Arm Type
Experimental
Arm Description
Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery)
Arm Title
Antibiotic treatment, wound infection
Arm Type
Active Comparator
Arm Description
Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery)
Intervention Type
Other
Intervention Name(s)
prophylaxis
Intervention Description
single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV
Intervention Type
Other
Intervention Name(s)
therapy
Intervention Description
antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day
Primary Outcome Measure Information:
Title
wound infection
Description
Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Length of the hospital stay
Description
Duration in days from admission until discharge
Time Frame
30 days
Title
Adverse effects treatment related
Description
Adverse effects derived from the usage of antibiotics
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study
Exclusion Criteria:
patients under 12 or older 65 years old
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry A Uscategui, Physician
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Camacho, Physician
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario de Santander
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
097
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16516631
Citation
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.
Results Reference
background
PubMed Identifier
12516811
Citation
Gollin G, Abarbanell A, Moores D. Oral antibiotics in the management of perforated appendicitis in children. Am Surg. 2002 Dec;68(12):1072-4.
Results Reference
background
PubMed Identifier
2647050
Citation
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.
Results Reference
background
PubMed Identifier
10686977
Citation
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.
Results Reference
result
PubMed Identifier
10231213
Citation
Lemieur TP, Rodriguez JL, Jacobs DM, Bennett ME, West MA. Wound management in perforated appendicitis. Am Surg. 1999 May;65(5):439-43.
Results Reference
result
PubMed Identifier
15529837
Citation
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.
Results Reference
result
PubMed Identifier
8418785
Citation
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. Erratum In: Arch Surg 1993 Apr;128(4):410.
Results Reference
result
PubMed Identifier
11257737
Citation
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.
Results Reference
result
PubMed Identifier
16034862
Citation
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.
Results Reference
result
PubMed Identifier
15943731
Citation
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.
Results Reference
result
PubMed Identifier
15480707
Citation
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Results Reference
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PubMed Identifier
15109590
Citation
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.
Results Reference
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PubMed Identifier
10571434
Citation
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Results Reference
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7548380
Citation
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Results Reference
result
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Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis
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