Gangrenous AppendicitisNCT01115153
Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis
A study testing prophylaxis and therapy in people with Gangrenous Appendicitis, run by Universidad Industrial de Santander at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Gangrenous Appendicitis
- What is being tested?
- prophylaxis and therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteColombia
- Study dates
- Dec 2007to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario de Santander
Bucaramanga, Santander Department, 097
About this study
Official title: Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis (Randomized, Controlled Clinical Trial)
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.
Read the 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.
- Conditions
- Gangrenous Appendicitis
- Being tested
- prophylaxis, therapy
- Keywords
- Acute appendicitis, Antibiotic prophylaxis, Wound infection, Nosocomial infection
- Medical subject headings
- Appendicitis, Wound Infection, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylaxisOther
single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV
therapyOther
antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic prophylaxis | Experimental | Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery) Receives: Other: prophylaxis |
| Antibiotic treatment, wound infection | Active comparator | Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery) Receives: Other: therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection
Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space
Measured: 30 days
Secondary outcomes (2)
Length of the hospital stay
Duration in days from admission until discharge
Measured: 30 days
Adverse effects treatment related
Adverse effects derived from the usage of antibiotics
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startDec 2007
- Primary completionNov 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Gangrenous AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Industrial de Santander
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Santander
- Responsible party
- Principal investigator, Henry Uscategui Cristancho, Universidad Industrial de Santander
- Investigators
- Henry A Uscategui, Physician, Principal investigator, Universidad Industrial de SantanderFrancisco Camacho, Physician, Study director, Universidad Industrial de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115153
- Sponsor's protocol ID
- 74186942
- Status last verified
- Aug 2011
- First submitted
- 19 Apr 2010
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16516631Gollin G, Abarbanell A, Moores D. Oral antibiotics in the management of perforated appendicitis in children. Am Surg. 2002 Dec;68(12):1072-4.
PubMed 12516811Bauer 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.
PubMed 2647050Rucinski 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.
PubMed 10686977Lemieur TP, Rodriguez JL, Jacobs DM, Bennett ME, West MA. Wound management in perforated appendicitis. Am Surg. 1999 May;65(5):439-43.
PubMed 10231213Taylor 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.
PubMed 15529837Page 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.
PubMed 8418785Gorecki 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.
PubMed 11257737Andersen 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.
PubMed 16034862Mui 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.
PubMed 15943731Snelling 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.
PubMed 15480707Gleisner 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.
PubMed 15109590Hoelzer 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.
PubMed 10571434Almqvist P, Leandoer L, Tornqvist A. Timing of antibiotic treatment in non-perforated gangrenous appendicitis. Eur J Surg. 1995 Jun;161(6):431-3.
PubMed 7548380
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis With Single Versus Five Dose of Antibiotic Therapy as Treatment of Patients With Gangrenous Acute Appendicitis (Randomized, Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT01115153
- Acronym / sponsor ID
- 74186942
- Conditions
- Gangrenous Appendicitis
- Keywords
- Acute appendicitis, Antibiotic prophylaxis, Wound infection, Nosocomial infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universidad Industrial de SantanderUniversity, hospital or other
- Collaborators
- Hospital Universitario de Santander
- Study start
- Dec 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic prophylaxis | Experimental | Other: prophylaxisRate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery) |
| Antibiotic treatment, wound infection | Active comparator | Other: therapyRate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prophylaxissingle doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV | Other | Antibiotic prophylaxis |
| therapyantibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day | Other | Antibiotic treatment, wound infection |
Primary outcome
wound infection
Time frame: 30 days
Signs of surgical wound infection as heat, pain, erythema and secretion with involvement of skin,subcutaneous tissue and organ or space
2 secondary outcomes
Length of the hospital stay
Time frame: 30 days
Adverse effects treatment related
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
- Background: PubMed 16516631Ein 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.
- Background: PubMed 12516811Gollin G, Abarbanell A, Moores D. Oral antibiotics in the management of perforated appendicitis in children. Am Surg. 2002 Dec;68(12):1072-4.
- Background: PubMed 2647050Bauer 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 publication: PubMed 10686977Rucinski 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 publication: PubMed 10231213Lemieur TP, Rodriguez JL, Jacobs DM, Bennett ME, West MA. Wound management in perforated appendicitis. Am Surg. 1999 May;65(5):439-43.
- Results publication: PubMed 15529837Taylor 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 publication: PubMed 8418785Page 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.
- Results publication: PubMed 11257737Gorecki 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 publication: PubMed 16034862Andersen 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 publication: PubMed 15943731Mui 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 publication: PubMed 15480707Snelling 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.
- Results publication: PubMed 15109590Gleisner 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.
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Recruiting
Out-patiente Management for Gangrenous Acute Appendicitis: The PENDI-CSI II Randomized Clinical Trial.
Appendicitis Acute, Gangrenous Appendicitis
Recruiting
Enhanced Recovery After Surgery (ERAS) for Complicated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry A Uscategui, Physician principal investigator
Universidad Industrial de Santander
Francisco Camacho, Physician study director
Universidad Industrial de Santander
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prophylaxis and therapy in people with Gangrenous Appendicitis, run by Universidad Industrial de Santander at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01115153, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2011.