NCT00613769

Brief Summary

The current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first line of treatment for abdominal surgical infections. Serval Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole. The combination is economical and believed to be effective but hitherto the outcome have not been properly researched. The aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,073

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

4.3 years

First QC Date

January 31, 2008

Last Update Submit

September 27, 2012

Conditions

Infection Prophylaxis in Colo Rectal Surgery

Keywords

Surgical site infections

Outcome Measures

Primary Outcomes (1)

  • Cutaneous-,subcutaneous and intraabdominal infections

    4 weeks

Secondary Outcomes (5)

  • Non infectious wound complications

    4 weeks

  • Complications to the anastomosis

    4 weeks

  • Adverse reaction of given drug

    4 weeks

  • Other post operative infections

    During hospital stay

  • Septicaemia

    4 weeks

Study Arms (2)

ordinary per operative prophylaxis

ACTIVE COMPARATOR

cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia

Drug: cefuroxime and metronidazole

Per oral alternative

EXPERIMENTAL

Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation

Drug: trimethoprim-sulfamethoxazole + metronidazole

Interventions

trimethoprim-sulfamethoxazole + metronidazoleDRUG

trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.

Per oral alternative
cefuroxime and metronidazoleDRUG

cefuromime 1500mg i.v. + metronidazole 1500mg i.v.

ordinary per operative prophylaxis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years
  • Planned clean/clean-contaminated colorectal resection will be performed
  • Understand spoken and written swedish language

You may not qualify if:

  • Hypersensibility to the test or control drug
  • Severe liver failure
  • Blood dyscrasia
  • Ileus or gastric retention
  • Current visceral perforation
  • Current treatment with antibiotics
  • Current treatment with steroids
  • Cytotoxic or radiation therapy within 4 weeks of the planned operation
  • Active IBD (inflammatory bowel disease)
  • Incapability to swallow tablets
  • Other study interfering with this study
  • Current pregnancy
  • Bad regulated diabetes
  • Current enterocutaneous or colocutaneous fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Surgery, University hospital Sahlgrenska/Östra

Gothenburg, 416 85, Sweden

Location

Department of Surgery and oncology, Halland Hospital in Halmstad

Halmstad, 301 85, Sweden

Location

Department of surgery, Community Hospital i Karlskrona

Karlskrona, 371 85, Sweden

Location

Vrinnevi hospital

Norrköping, 601 82, Sweden

Location

Department of surgery

Skövde, 541 85, Sweden

Location

Department of Surgery, NU-hospitals

Uddevalla, 451 80, Sweden

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Trimethoprim, Sulfamethoxazole Drug CombinationMetronidazoleCefuroxime

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsNitroimidazolesNitro CompoundsImidazolesAzolesCephalosporinsbeta-LactamsLactamsThiazinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Claes Hjalmarsson, MD,PhD

    Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MDPhD

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

SE(6)