NCT01115153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
Last Updated

August 23, 2011

Status Verified

August 1, 2011

Enrollment Period

1.9 years

First QC Date

April 19, 2010

Last Update Submit

August 22, 2011

Conditions

Gangrenous Appendicitis

Keywords

Acute appendicitisAntibiotic prophylaxisWound infectionNosocomial infection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Length of the hospital stay

    30 days

  • Adverse effects treatment related

    30 days

Study Arms (2)

Antibiotic prophylaxis

EXPERIMENTAL

Rate of Wound infection in patients with gangrenous appendicitis with single doses of antibiotic (before surgery)

Other: prophylaxis

Antibiotic treatment, wound infection

ACTIVE COMPARATOR

Rate of Wound infection in patients with gangrenous appendicitis with five days antibiotic therapy (after surgery)

Other: therapy

Interventions

prophylaxisOTHER

single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV

Antibiotic prophylaxis
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

Antibiotic treatment, wound infection

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Santander

Bucaramanga, Santander Department, 097, Colombia

Location

Related Publications (14)

  • 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.

    PMID: 16516631BACKGROUND

  • Gollin G, Abarbanell A, Moores D. Oral antibiotics in the management of perforated appendicitis in children. Am Surg. 2002 Dec;68(12):1072-4.

    PMID: 12516811BACKGROUND

  • 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.

    PMID: 2647050BACKGROUND

  • 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.

    PMID: 10686977RESULT

  • Lemieur TP, Rodriguez JL, Jacobs DM, Bennett ME, West MA. Wound management in perforated appendicitis. Am Surg. 1999 May;65(5):439-43.

    PMID: 10231213RESULT

  • 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.

    PMID: 15529837RESULT

  • 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.

    PMID: 8418785RESULT

  • 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.

    PMID: 11257737RESULT

  • 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.

    PMID: 16034862RESULT

  • 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.

    PMID: 15943731RESULT

  • 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.

    PMID: 15480707RESULT

  • 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.

    PMID: 15109590RESULT

  • 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.

    PMID: 10571434RESULT

  • Almqvist P, Leandoer L, Tornqvist A. Timing of antibiotic treatment in non-perforated gangrenous appendicitis. Eur J Surg. 1995 Jun;161(6):431-3.

    PMID: 7548380RESULT

MeSH Terms

Conditions

AppendicitisWound InfectionCross Infection

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henry A Uscategui, Physician

    Universidad Industrial de Santander

    PRINCIPAL INVESTIGATOR

  • Francisco Camacho, Physician

    Universidad Industrial de Santander

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

April 19, 2010

First Posted

May 4, 2010

Study Start

December 1, 2007

Primary Completion

November 1, 2009

Study Completion

February 1, 2010

Last Updated

August 23, 2011

Record last verified: 2011-08

Locations

CO(1)