Postoperative HerniaPhase 3(PROTOP-PAR)NCT05508152
Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR)
A Phase 3 study testing Wound irrigation with amoxicillin-clavulanate in saline solution and Wound irrigation with a saline solution in people with Postoperative Hernia, 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
- Postoperative Hernia
- What is being tested?
- Wound irrigation with amoxicillin-clavulanate in saline solution and Wound irrigation with a saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 30 Jun 2023
- Phase
- Phase 3
- 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 who require an elective surgical procedure due to an abdominal wall incisional hernia.
Who cannot join
- Emergency surgery
- Parastomal hernia
- Patients under treatment with immunosuppressants, corticosteroids and patients on hemodialysis.
- Patients with liver cirrhosis.
- Patients with suspected allergy to bata-lactams antibiotics.
- Patients who have undergone a recent open abdomen surgical technique (up to 30 days pre-intervention), placement of a prosthesis made of synthetic material (mesh) or in which the wound cannot be closed surgery at the discretion of the surgeon.
- Patients defined as grade 5 of the American Association of Anaesthesiologists classification (ASA 5).
Trial locations and contacts
1 site in 1 country.
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 incisional hernia repair after abdominal surgery.
Method. Randomized double-blind clinical trial comparing two groups of topical prophylaxis. Follow-up will be 90 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, a high level of use of wound irrigation at the end of an intervention in actual clinical practice has been observed. In a survey conducted by 2017 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).
SSI rates after complex incisional hernia repair are higher than previously reported. In a recent paper, this research team observed that patients with SSI after hernia repair showed more prolonged surgical procedures, and a higher one-year recurrence rate. Multivariable analysis revealed the only identified risk factor for SSI to be post-operative sero-hematomas. Patients who developed an SSI required antibiotic agents and daily treatment from one to five months. One of these required the removal of the mesh. SSI rates were high for incisional hernia surgery (16%), and were associated with local complications.
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 incisional hernia surgery with different levels of contamination.
The study will compare the efficacy of topical prophylaxis with saline with a solution of amoxicillin-clavulanate in the incidence of SSI in incisional hernia repair.
It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV.
Design of study The irrigation of the wound with 0.9% saline will be compared with the irrigation with an active principle solution of a pharmaceutical specialty of proven efficacy (amoxicillin-clavulanate) by parenteral route, administered topically and dissolved in saline.
The two groups of the study will be named: Study Group (irrigation with antibiotic solution) and 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
- Postoperative Hernia
- Being tested
- Wound irrigation with amoxicillin-clavulanate in saline solution, Wound irrigation with a saline solution
- Keywords
- Surgical site infection, Incisional hernia, Topical prophylaxis, Wound irrigation, Topical antibiotic prophylaxis
- Medical subject headings
- Incisional Hernia, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound irrigation with amoxicillin-clavulanate in saline solutionDrug
Also called Antibiotic
Randomization will be made by means of the RedCap online program. At the arrival of the patient in the surgical area, the nursing team will be informed whether or not the patient has entered the protocol of the studio.
For each included case, the perioperative nurse will access RedCap and will proceed to include and randomize the case.
Once the patient's data has been introduced, the circulating nurse will enter the intervention group in a registration database, keeping it blinded to the surgical team.
In the experimental arm of the study, the circulating nurse will prepare a solution of amoxicillin-clavulanate acid (1000 mg of antibiotic in 500 mL of saline) outside the operating room. In case of open surgery, the thickness of the subcutaneous fat layer will be measured and recorded. After the closure of the aponeurosis, and before the closure of the skin, the wound will be irrigated with the antibiotic solution, and the soaked gauze placed on the wound for 3 minutes.
Wound irrigation with a saline solutionDrug
Also called Saline
Randomization will be made by means of the RedCap online program. At the arrival of the patient in the surgical area, the nursing team will be informed whether or not the patient has entered the protocol of the studio. For each included case, the perioperative nurse will access RedCap and will proceed to include and randomize the case.
Once the patient's data has been introduced, the circulating nurse will enter the intervention group in a registration database, keeping it blinded to the surgical team.
If the case belongs to the sham group, at the end of the intervention, the circulating nurse will prepare a sham solution contaning only normal saline outside the operating room. In case of open surgery, the thickness of the subcutaneous fat layer will be measured and recorded. After the closure of the aponeurosis, and before the closure of the skin, the wound will be irrigated with saline, and the soaked gauze placed on the wound for 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Wound irrigation with saline | Sham comparator | After the closure of the aponeurosis, and before the closure of the skin, the subcutaneous layer of the wound will be rinsed with a determined volume (depending on the diameter of the incision) of a saline solution. Then, a gauze soaked with the same solution will be placed in the wound for 3 minutes. Receives: Drug: Wound irrigation with a saline solution |
| Wound irrigation with antibiotic | Experimental | After the closure of the aponeurosis, and before the closure of the skin, the subcutaneous layer of the wound will be rinsed with a determined volume (depending on the diameter of the incision) of amoxicillin-clavulanate in saline solution. Then, a gauze soaked with the same solution will be placed in the wound for 3 minutes. Receives: Drug: Wound irrigation with amoxicillin-clavulanate in saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection rate
The primary study end point will be the development of a Surgical Site Infection (SSI) within 90 days of operation, according to the definitions of the Centres for Disease Control and Prevention (CDC).
SSI will be defined as superficial incisional (S-SSI), deep incisional (D-SSI) or organ-space (O/S-SSI).
The incidence of SSI will be measured as events per 100 included procedures.
Measured: 90 days
Secondary outcomes (3)
Hospital stay
To study the effect of topical antibiotic prophylaxis on hospital stay.
Measured: 90 days
Healthcare cost
To study the effect of topical antibiotic prophylaxis on healthcare costs. Using the existing computer systems in the participating hospitals, hospital analytical accounting tools will be used to compare the costs of healthcare between the two groups. Among other items, the costs for hospital stay, surgical interventions, drugs (especially the use of antibiotics), readmissions, medical supplies and staff costs will be analysed.
Measured: 90 days
Bacterial resistance
To analyze the effect of topical antibiotic prophylaxis on the resistance patterns of the flora causing SSI. The percentages of multiresistant bacteria will be compared in the year prior to the start of the study against the period of development of the study in the clinical services participating in the trial. In addition, if there are postoperative infections with positive microbiology results, the percentage of multiresistant bacteria in the sham group will be compared with the intervention group.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Feb 2021
- Primary completion30 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HerniaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508152
- Sponsor's protocol ID
- PROTOP-PAR
- Acronym
- (PROTOP-PAR)
- Status last verified
- Aug 2022
- First submitted
- 4 May 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be provided at request
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR)
- ClinicalTrials.gov ID
- NCT05508152
- Acronym / sponsor ID
- (PROTOP-PAR) / PROTOP-PAR
- Conditions
- Postoperative Hernia
- Keywords
- Surgical site infection, Incisional hernia, Topical prophylaxis, Wound irrigation, Topical antibiotic prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Aug 2022 (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 incisional hernia repair after abdominal surgery.
Method. Randomized double-blind clinical trial comparing two groups of topical prophylaxis. Follow-up will be 90 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, a high level of use of wound irrigation at the end of an intervention in actual clinical practice has been observed. In a survey conducted by 2017 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).
SSI rates after complex incisional hernia repair are higher than previously reported. In a recent paper, this research team observed that patients with SSI after hernia repair showed more prolonged surgical procedures, and a higher one-year recurrence rate. Multivariable analysis revealed the only identified risk factor for SSI to be post-operative sero-hematomas. Patients who developed an SSI required antibiotic agents and daily treatment from one to five months. One of these required the removal of the mesh. SSI rates were high for incisional hernia surgery (16%), and were associated with local complications.
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 incisional hernia surgery with different levels of contamination.
The study will compare the efficacy of topical prophylaxis with saline with a solution of amoxicillin-clavulanate in the incidence of SSI in incisional hernia repair.
It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV.
Design of study The irrigation of the wound with 0.9% saline will be compared with the irrigation with an active principle solution of a pharmaceutical specialty of proven efficacy (amoxicillin-clavulanate) by parenteral route, administered topically and dissolved in saline.
The two groups of the study will be named: Study Group (irrigation with antibiotic solution) and 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
| Arm | Type | Receives |
|---|---|---|
| Wound irrigation with saline | Sham comparator | Drug: Wound irrigation with a saline solutionAfter the closure of the aponeurosis, and before the closure of the skin, the subcutaneous layer of the wound will be rinsed with a determined volume (depending on the diameter of the incision) of a saline solution. Then, a gauze soaked with the same solution will be placed in the wound for 3 minutes. |
| Wound irrigation with antibiotic | Experimental | Drug: Wound irrigation with amoxicillin-clavulanate in saline solutionAfter the closure of the aponeurosis, and before the closure of the skin, the subcutaneous layer of the wound will be rinsed with a determined volume (depending on the diameter of the incision) of amoxicillin-clavulanate in saline solution. Then, a gauze soaked with the same solution will be placed in the wound for 3 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who require an elective surgical procedure due to an abdominal wall incisional hernia.
Key exclusion criteria (7 listed)
- Emergency surgery
- Parastomal hernia
- Patients under treatment with immunosuppressants, corticosteroids and patients on hemodialysis.
- Patients with liver cirrhosis.
- Patients with suspected allergy to bata-lactams antibiotics.
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 |
|---|---|---|
| Wound irrigation with amoxicillin-clavulanate in saline solutionAlso: AntibioticRandomization will be made by means of the RedCap online program. At the arrival of the patient in the surgical area, the nursing team will be informed whether or not the patient has entered the protocol of the studio. For each included case, the perioperative nurse will access RedCap and will proceed to include and randomize the case. Once the patient's data has been introduced, the circulating nurse will enter the intervention group in a registration database, keeping it blinded to the surgical team. In the experimental arm of the study, the circulating nurse will prepare a solution of amoxicillin-clavulanate acid (1000 mg of antibiotic in 500 mL of saline) outside the operating room. In case of open surgery, the thickness of the subcutaneous fat layer will be measured and recorded. After the closure of the aponeurosis, and before the closure of the skin, the wound will be irrigated with the antibiotic solution, and the soaked gauze placed on the wound for 3 minutes. | Drug | Wound irrigation with antibiotic |
| Wound irrigation with a saline solutionAlso: SalineRandomization will be made by means of the RedCap online program. At the arrival of the patient in the surgical area, the nursing team will be informed whether or not the patient has entered the protocol of the studio. For each included case, the perioperative nurse will access RedCap and will proceed to include and randomize the case. Once the patient's data has been introduced, the circulating nurse will enter the intervention group in a registration database, keeping it blinded to the surgical team. If the case belongs to the sham group, at the end of the intervention, the circulating nurse will prepare a sham solution contaning only normal saline outside the operating room. In case of open surgery, the thickness of the subcutaneous fat layer will be measured and recorded. After the closure of the aponeurosis, and before the closure of the skin, the wound will be irrigated with saline, and the soaked gauze placed on the wound for 3 minutes. | Drug | Wound irrigation with saline |
Primary outcome
Surgical Site Infection rate
Time frame: 90 days
The primary study end point will be the development of a Surgical Site Infection (SSI) within 90 days of operation, according to the definitions of the Centres for Disease Control and Prevention (CDC). SSI will be defined as superficial incisional (S-SSI), deep incisional (D-SSI) or organ-space (O/S-SSI). The incidence of SSI will be measured as events per 100 included procedures.
3 secondary outcomes
Hospital stay
Time frame: 90 days
Healthcare cost
Time frame: 90 days
Bacterial resistance
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No. Data will be provided at request
Related trials for Postoperative Hernia
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Not yet recruiting
The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
Ventral Hernia, Ventral Incisional Hernia
Recruiting
Effect of Anterior Iliac Block on Postoperative Analgesia and Patient Satisfaction in Inguinal Hernia Repair Surgery
Anterior Ilıac Block, Hernia Surgery
Not yet recruiting
Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
Inguinal Hernia Unilateral, Postoperative Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Wound irrigation with amoxicillin-clavulanate in saline solution and Wound irrigation with a saline solution in people with Postoperative Hernia, 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 22 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection rate (time frame: 90 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 22 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.