Trial Outcomes & Findings for Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days (NCT NCT01203046)

NCT ID: NCT01203046

Last Updated: 2012-08-10

Results Overview

The patients were evaluated up to 10 days with close observation of surgical site. We concluded as surgical site infection when inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption was observed.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

56 participants

Primary outcome timeframe

10 days

Results posted on

2012-08-10

Participant Flow

The data was collected between December 2010 and November 2011 including patients with penetrating abdominal trauma admitted at Dr. Miguel Perez Carreño Hospital emergency room.

We were behind schedule to start the trial waiting for institutional approve.

Participant milestones

Participant milestones
Measure	GROUP A: 7 DAYS ANTIBIOTIC THERAPY Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial. Group A will be treated with Ertapenem during the following four days.	GROUP B: 3 DAYS ANTIBIOTIC THERAPY Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial. Group B will be treated with placebo during the following four days.
Overall Study STARTED	28	28
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GROUP A: 7 DAYS ANTIBIOTIC THERAPY n=28 Participants Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial. Group A will be treated with Ertapenem during the following four days.	GROUP B: 3 DAYS ANTIBIOTIC THERAPY n=28 Participants Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial. Group B will be treated with placebo during the following four days.	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	26.2857 years STANDARD_DEVIATION 9.5450 • n=5 Participants	28.5000 years STANDARD_DEVIATION 9.8639 • n=7 Participants	27.3929 years STANDARD_DEVIATION 9.6929 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Type of trauma GSW	24 participants n=5 Participants	22 participants n=7 Participants	46 participants n=5 Participants
Type of trauma SW	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Population: All patients with inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption observed at surgical site were included.

Outcome measures

Outcome measures
Measure	GROUP A: 7 DAYS THERAPY n=28 Participants Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial. Group A will be treated with Ertapenem during the following four days.	GROUP B - 3 DAYS THERAPY n=28 Participants Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial. Group B will be treated with placebo during the following four days.
Surgical Site Infection	6 participants	3 participants

PRIMARY outcome

Timeframe: 10 days

Population: Patients who presented any complication different of surgical site infection after surgery

Patients with complications different to surgical site infection.

Outcome measures

Outcome measures
Measure	GROUP A: 7 DAYS THERAPY n=28 Participants Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial. Group A will be treated with Ertapenem during the following four days.	GROUP B - 3 DAYS THERAPY n=28 Participants Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial. Group B will be treated with placebo during the following four days.
Other Complications	8 participants	5 participants

Adverse Events

GROUP A: 7 DAYS ANTIBIOTIC THERAPY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GROUP B: 3 DAYS ANTIBIOTIC THERAPY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Silvia M. Pinango L.

Dr. Silvia M. Pinango L

Phone: +584169267988

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place