Surgical Wound Infection, Postoperative Wound Infection, Postoperative Wound Infection Superficial Incisional, Preventive Therapy
Conditions
Keywords
topical antibiotic, surgical wound infection, prevention of surgical wound infection
Brief summary
The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery
Detailed description
Is a clinical trial phase IV prospective, blind, controlled and random allocation of treatment with the active principle of amoxicillin 1000mg and 200mg Clavulanic acid, administered topically and dissolved in 500 ml of saline 0.9%. To demonstrate its effectiveness in the surgical wound infection prophylaxis be used in contaminated surgery and be compared its effectiveness with the topical administration of normal saline only.
Interventions
To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.
DRUGPhysiological Saline
To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.
Sponsors
Hospital de Granollers
Universitat Internacional de Catalunya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
In the operating room area we will keep a notebook with the random number sheet and a box with the numbered envelopes and containing the treatment to follow: physiological saline alone or physiological saline with antibiotic. At the end of the surgery and before closing the abdominal wall, it is definitively informed to the nurse whether or not to recruit them, a case number is assigned chronologically and in the random number sheet corresponds to an envelope containing one of the two treatments. Dilution is performed with 10cc of physiological saline solution with or without antibiotic in the outside of the operating room and then it is incorporated into the 500cc bottle of physiological saline once opened in a sterile way. We used according to the usual protocol.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age. * Patients who require urgent surgical intervention and who come from the emergency service * Patients affected by complicated intra-abdominal infection with peritonitis of more than one abdominal compartment or intra-abdominal abscess requiring open surgical intervention.
Exclusion criteria
* Women patients with positive pregnancy test. * Patients with primary peritonitis and liver cirrhosis. * Patients who have received antibiotic treatment during the 72 hours prior to the surgical intervention (except that administered to UCIES as a treatment dose of the same process) * Patients allergic to the antibiotic used in the study. * Patients who have undergone a surgical procedure of recently opened abdomen (up to 30 days before surgery), a prosthesis of synthetic material (mesh) or to which the surgical wound can not be closed according to the surgeon's criteria. * Patients with an unfavorable life prognosis (ASA 5).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI | 30 days | Evaluation of the effect of topical antibiòtic ( Amoxicillin 1000mg and 200mg of Clavulanic acid dissolved in 500 milliliters of 0.9% Physiological Serum ) prophylaxis on the incidence of Surgical Site Infection in surgery due to emergency intra-abdominal infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction of hospital stay | 30 days | Effect of the protocol of topical prophylaxis in the reduction of hospital stay |
| Bacterial charge | 30 days | Effect of topical prophylaxis protocol on reducing bacterial charge |
| Bacterial resistance | 30 days | Effect of topical prophylaxis protocol on Bacterial resistance |
Countries
Spain
Outcome results
None listed