Surgical Site InfectionNCT04476212
Prophylaxis of Surgical Wound Infection With Topical Antibiotics
A study testing Topical antibiotic prophylaxis in people with Surgical Site Infection and Surgery--Complications, run by Hospital de Granollers at 1 site in Spain.
Trial summary
Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Surgery--Complications, Colorectal Surgery
- What is being tested?
- Topical antibiotic prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteSpain
- Study dates
- 27 Dec 2018to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted for elective abdominal wall surgery by open route
- Patients admitted for urgent or elective cesarean section
- Patients undergoing elective surgery of the colon or rectum for neoplastic pathology (open or laparoscopy)
- Patients undergoing emergency abdominal surgery (open or laparoscopy)
Who cannot join
- Patients under treatment with immunosuppressors, corticosteroids and patients on hemodialysis
- Patients with primary peritonitis and liver cirrhosis
- Patients with suspected allergy to the antibiotic used in the study
- Patients who have recently undergone open abdomen surgery (up to 30 days pre-intervention) or to which the wound can not be closed surgical according to the surgeon's criteria
- Patients with American Society of Anaesthesiology classification 5.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundació Privada Hospital Asil de Granollers
Granollers, Barcelona, 08402
Josep Maria Badia, PhD, (+34) 938 425 000 ext. 2571, jmbadia@fhag.es
Gemma Molist, PhD, (+34) 938 425 000 ext. 2973, recerca@fhag.es
About this study
Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. In experimental conditions there is evidence in favor of the efficiency wound lavage with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk of infection. Method. Project comprising several randomized double-blind clinical trials with a common methodology. Procedures with varying degrees of contamination, as emergency abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied. Follow-up will be 30 days after operation. Data will be collected anonymously and the relationships between the variables will be analyzed using Pearson's chi-square, survival analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.
Read the detailed description
Several Surgical site infection (SSI) prevention guidelines have been published over the last 10 years. Topical prophylaxis of the surgical wound with antibiotics or antiseptics is one of the most controversial measures proposed for SSI prevention. Two guidelines (British, Spanish Ministry of Health) explicitly recommend not irrigating surgical wounds with any product. The World Health Organization considers irrigation with antibiotics as an unresolved issue and, together with the Centers for Disease Control, recommends irrigation with a solution of povidone iodine. The other four guides do not mention the measure. In Catalonia, a SSI prevention bundle recommends wound irrigation with saline, with a low level of recommendation.
Therefore, topical prophylaxis with operational wound washings with different solutions has been poorly studied, evokes contradictory recommendations and is not included in the majority of clinical practice guidelines for SSI prevention.
However, there we detected a high level of use of wound irrigation at the end of an intervention in actual clinical practice. In a survey conducted by 2017 by our group and answered by 845 general surgeons of the Spanish Association of Surgeons, before closing the skin, most surgeons (80.6%) irrigate the subcutaneous layer of the wound, either with saline (51.2%), an antiseptic solution (23.8%) or an antibiotic solution (1.5%). Only 19.4% of respondents do not irrigate. In another survey in 2018, focused on colorectal surgeons of two Spanish associations, similar rates of irrigation with saline, antiseptic or antibiotic were used (55%, 28.9% and 2.2%, respectively) The hypothesis of the study is that topical prophylaxis of the surgical wound with irrigation with an antibiotic solution decreases the rate of postoperative infection in patients undergoing abdominal surgery with different levels of contamination.
The study will compare the efficacy of topical prophylaxis in the surgical wound with an irrigation with an antibiotic solution in the incidence of SSI in abdominal surgery.
It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV.
Design of studies The project includes several prospective comparative studies on the effect of irrigation of surgical wounds with an antibiotic solution on the incisional SSI rate in abdominal surgery. The studies share a unique methodology applied to various types of abdominal surgery with different expected SSI rates and different risk factors.
In the trials, the irrigation of the wound with 0.9% physiological serum will be compared with the irrigation with an active principle solution of a pharmaceutical specialty of proven efficacy by parenteral route, administered topically and dissolved in physiological serum.
Four studies on different types of operations are defined according to the risk of infection:
- Study 1. Complex abdominal wall surgery
- Study 2. Cesarean section
- Study 3. Colorectal elective surgery
- Study 4. Emergency abdominal surgery For each study two groups will be formed, the study group (irrigation with antibiotic solution) and the control group (irrigation with saline).
The project has received the Spanish Drug Agency authorization as a low intervention study, a grant from the Spanish Ministry of Health and the Ethics Committee authorization of the Hospital General of Granollers.
- Conditions
- Surgical Site Infection, Surgery--Complications, Colorectal Surgery, Cesarean Section; Infection, Hernia, Abdominal
- Being tested
- Topical antibiotic prophylaxis
- Keywords
- Surgical site infection, Prevention, Topical prophylaxis, Wound irrigation, Topical antibiotic prophylaxis, Abdominal surgery
- Medical subject headings
- Surgical Wound Infection, Infections, Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical antibiotic prophylaxisOther
The surgical wound will be irrigated with an antibiotic solution, and then we will apply the same solution using gauze for two minutes on the wound
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the experimental arm, the surgical wound will be irrigated using an antibiotic solution (amoxicillin-clavulanate) for topical prophylaxis Receives: Other: Topical antibiotic prophylaxis |
| Control | No intervention | In the control arm, the surgical wound will be irrigated with saline, which is our routine at present. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site infection rate
signs of infection at any level of surgical site
Measured: 30 days
Secondary outcomes (1)
Complications after surgery
Any complication after surgery, evaluated by the Clavien-dindo classification
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start27 Dec 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV. The irrigation of the wound with 0.9% physiological serum will be compared with the irrigation with a solution of amoxicillin-clavulanate, administered topically and dissolved in saline.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josep Maria Badia, PhD, Principal investigator, Fundació Privada Hospital Asil de GranollersFelipe Ojeda, PhD, Principal investigator, Fundació Privada Hospital Asil de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476212
- Sponsor's protocol ID
- 20171013
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Surgical Wound Infection With Topical Antibiotics
- ClinicalTrials.gov ID
- NCT04476212
- Acronym / sponsor ID
- 20171013
- Conditions
- Surgical Site Infection, Surgery--Complications, Colorectal Surgery, Cesarean Section; Infection, Hernia, Abdominal
- Keywords
- Surgical site infection, Prevention, Topical prophylaxis, Wound irrigation, Topical antibiotic prophylaxis, Abdominal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. In experimental conditions there is evidence in favor of the efficiency wound lavage with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk of infection. Method. Project comprising several randomized double-blind clinical trials with a common methodology. Procedures with varying degrees of contamination, as emergency abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied. Follow-up will be 30 days after operation. Data will be collected anonymously and the relationships between the variables will be analyzed using Pearson's chi-square, survival analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.
Detailed description
Several Surgical site infection (SSI) prevention guidelines have been published over the last 10 years. Topical prophylaxis of the surgical wound with antibiotics or antiseptics is one of the most controversial measures proposed for SSI prevention. Two guidelines (British, Spanish Ministry of Health) explicitly recommend not irrigating surgical wounds with any product. The World Health Organization considers irrigation with antibiotics as an unresolved issue and, together with the Centers for Disease Control, recommends irrigation with a solution of povidone iodine. The other four guides do not mention the measure. In Catalonia, a SSI prevention bundle recommends wound irrigation with saline, with a low level of recommendation.
Therefore, topical prophylaxis with operational wound washings with different solutions has been poorly studied, evokes contradictory recommendations and is not included in the majority of clinical practice guidelines for SSI prevention.
However, there we detected a high level of use of wound irrigation at the end of an intervention in actual clinical practice. In a survey conducted by 2017 by our group and answered by 845 general surgeons of the Spanish Association of Surgeons, before closing the skin, most surgeons (80.6%) irrigate the subcutaneous layer of the wound, either with saline (51.2%), an antiseptic solution (23.8%) or an antibiotic solution (1.5%). Only 19.4% of respondents do not irrigate. In another survey in 2018, focused on colorectal surgeons of two Spanish associations, similar rates of irrigation with saline, antiseptic or antibiotic were used (55%, 28.9% and 2.2%, respectively) The hypothesis of the study is that topical prophylaxis of the surgical wound with irrigation with an antibiotic solution decreases the rate of postoperative infection in patients undergoing abdominal surgery with different levels of contamination.
The study will compare the efficacy of topical prophylaxis in the surgical wound with an irrigation with an antibiotic solution in the incidence of SSI in abdominal surgery.
It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV.
Design of studies The project includes several prospective comparative studies on the effect of irrigation of surgical wounds with an antibiotic solution on the incisional SSI rate in abdominal surgery. The studies share a unique methodology applied to various types of abdominal surgery with different expected SSI rates and different risk factors.
In the trials, the irrigation of the wound with 0.9% physiological serum will be compared with the irrigation with an active principle solution of a pharmaceutical specialty of proven efficacy by parenteral route, administered topically and dissolved in physiological serum.
Four studies on different types of operations are defined according to the risk of infection:
- Study 1. Complex abdominal wall surgery
- Study 2. Cesarean section
- Study 3. Colorectal elective surgery
- Study 4. Emergency abdominal surgery For each study two groups will be formed, the study group (irrigation with antibiotic solution) and the control group (irrigation with saline).
The project has received the Spanish Drug Agency authorization as a low intervention study, a grant from the Spanish Ministry of Health and the Ethics Committee authorization of the Hospital General of Granollers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV. The irrigation of the wound with 0.9% physiological serum will be compared with the irrigation with a solution of amoxicillin-clavulanate, administered topically and dissolved in saline.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Topical antibiotic prophylaxisIn the experimental arm, the surgical wound will be irrigated using an antibiotic solution (amoxicillin-clavulanate) for topical prophylaxis |
| Control | No intervention | –In the control arm, the surgical wound will be irrigated with saline, which is our routine at present. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted for elective abdominal wall surgery by open route
- Patients admitted for urgent or elective cesarean section
- Patients undergoing elective surgery of the colon or rectum for neoplastic pathology (open or laparoscopy)
- Patients undergoing emergency abdominal surgery (open or laparoscopy)
Key exclusion criteria (5 listed)
- Patients under treatment with immunosuppressors, corticosteroids and patients on hemodialysis
- Patients with primary peritonitis and liver cirrhosis
- Patients with suspected allergy to the antibiotic used in the study
- Patients who have recently undergone open abdomen surgery (up to 30 days pre-intervention) or to which the wound can not be closed surgical according to the surgeon's criteria
- Patients with American Society of Anaesthesiology classification 5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical antibiotic prophylaxisThe surgical wound will be irrigated with an antibiotic solution, and then we will apply the same solution using gauze for two minutes on the wound | Other | Intervention |
Primary outcome
Surgical Site infection rate
Time frame: 30 days
signs of infection at any level of surgical site
1 secondary outcome
Complications after surgery
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Maria Badia, PhD principal investigator
Fundació Privada Hospital Asil de Granollers
Felipe Ojeda, PhD principal investigator
Fundació Privada Hospital Asil de Granollers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical antibiotic prophylaxis in people with Surgical Site Infection and Surgery--Complications, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josep Maria Badia, PhD ((+34) 938 425 000 ext. 2571, jmbadia@fhag.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site infection rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.