Back to resultsStudy the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery (PROTOP)
Primary Purpose
Surgical Wound Infection, Postoperative Wound Infection, Postoperative Wound Infection Superficial Incisional
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Amoxicillin Clavulanate
Physiological Saline
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring topical antibiotic, surgical wound infection, prevention of surgical wound infection
Eligibility Criteria
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).
Sites / Locations
- Hospital General de Granollers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
amoxicillin clavulanate
Physiological Saline
Arm Description
1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.
500 milliliters of 0.9% Physiological Serum.
Outcomes
Primary Outcome Measures
Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI
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 Outcome Measures
reduction of hospital stay
Effect of the protocol of topical prophylaxis in the reduction of hospital stay
Bacterial charge
Effect of topical prophylaxis protocol on reducing bacterial charge
Bacterial resistance
Effect of topical prophylaxis protocol on Bacterial resistance
Full Information
NCT ID
NCT03574090
First Posted
May 30, 2018
Last Updated
June 11, 2023
Sponsor
Universitat Internacional de Catalunya
Collaborators
Hospital de Granollers
1. Study Identification
Unique Protocol Identification Number
NCT03574090
Brief Title
Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery
Acronym
PROTOP
Official Title
PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya
Collaborators
Hospital de Granollers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection, Postoperative Wound Infection, Postoperative Wound Infection Superficial Incisional, Preventive Therapy
Keywords
topical antibiotic, surgical wound infection, prevention of surgical wound infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amoxicillin clavulanate
Arm Type
Experimental
Arm Description
1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum.
Arm Title
Physiological Saline
Arm Type
Active Comparator
Arm Description
500 milliliters of 0.9% Physiological Serum.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Clavulanate
Other Intervention Name(s)
1000 mg amoxicillin and 200mg clavulanic acid.
Intervention Description
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
Intervention Name(s)
Physiological Saline
Other Intervention Name(s)
500 milliliters of 0.9% Physiological Serum
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
reduction of hospital stay
Description
Effect of the protocol of topical prophylaxis in the reduction of hospital stay
Time Frame
30 days
Title
Bacterial charge
Description
Effect of topical prophylaxis protocol on reducing bacterial charge
Time Frame
30 days
Title
Bacterial resistance
Description
Effect of topical prophylaxis protocol on Bacterial resistance
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Maria Badia Perez, PH. D
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General de Granollers
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08402
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Links:
URL
https://catsalut.gencat.cat/ca/proveidors-professionals/vincat/
Description
VINCat
URL
https://scientiasalut.gencat.cat/handle/11351/3304
Description
health prevention
Learn more about this trial
Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery
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