Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery
NCT ID: NCT03574090
Last Updated: 2023-06-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
268 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-10-20
Study Completion Date
2023-06-11
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Surgical Wound Infection
Postoperative Wound Infection
Postoperative Wound Infection Superficial Incisional
Preventive Therapy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
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.
Study Groups
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amoxicillin clavulanate
1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.
Group Type
EXPERIMENTAL
Amoxicillin Clavulanate
Intervention Type
DRUG
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.
Physiological Saline
Intervention Type
DRUG
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.
Physiological Saline
500 milliliters of 0.9% Physiological Serum.
Group Type
ACTIVE_COMPARATOR
Physiological Saline
Intervention Type
DRUG
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.
Interventions
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Amoxicillin Clavulanate
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.
Intervention Type
DRUG
Physiological 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.
Intervention Type
DRUG
Other Intervention Names
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1000 mg amoxicillin and 200mg clavulanic acid.
500 milliliters of 0.9% Physiological Serum
Eligibility Criteria
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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.
* 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).
* 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).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital de Granollers
OTHER
Sponsor Role
collaborator
Universitat Internacional de Catalunya
OTHER
Sponsor Role
lead
Responsible Party
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Miquel Casal Rossell
General Surgeon
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Josep Maria Badia Perez, PH. D
Role: STUDY_DIRECTOR
Universitat Internacional de Catalunya
Locations
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Hospital General de Granollers
Granollers, Barcelona, Spain
Site Status
Countries
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Spain
References
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Related Links
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Other Identifiers
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1234
Identifier Type: -
Identifier Source: org_study_id
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