Surgical Wound InfectionPhase 4PROTOPNCT03574090
Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery
A Phase 4 study testing Amoxicillin Clavulanate and Physiological Saline in people with Surgical Wound Infection and Postoperative Wound Infection, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection, Postoperative Wound Infection, Postoperative Wound Infection Superficial Incisional
- What is being tested?
- Amoxicillin Clavulanate and Physiological Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2020to 11 Jun 2023
- Phase
- Phase 4
- 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 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery
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
Read the 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.
- Conditions
- Surgical Wound Infection, Postoperative Wound Infection, Postoperative Wound Infection Superficial Incisional, Preventive Therapy
- Being tested
- Amoxicillin Clavulanate, Physiological Saline
- Keywords
- topical antibiotic, surgical wound infection, prevention of surgical wound infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin ClavulanateDrug
Also called 1000 mg amoxicillin and 200mg clavulanic acid.
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 SalineDrug
Also called 500 milliliters of 0.9% Physiological Serum
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.
| Study group | Role | What they receive |
|---|---|---|
| amoxicillin clavulanate | Experimental | 1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum. Receives: Drug: Amoxicillin Clavulanate; Drug: Physiological Saline |
| Physiological Saline | Active comparator | 500 milliliters of 0.9% Physiological Serum. Receives: Drug: Physiological Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (3)
reduction of hospital stay
Effect of the protocol of topical prophylaxis in the reduction of hospital stay
Measured: 30 days
Bacterial charge
Effect of topical prophylaxis protocol on reducing bacterial charge
Measured: 30 days
Bacterial resistance
Effect of topical prophylaxis protocol on Bacterial resistance
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 posted29 Jun 2018
- Study start20 Oct 2020
- Primary completion30 May 2023
- Study completion11 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Granollers
- Responsible party
- Principal investigator, Miquel Casal Rossell, Universitat Internacional de Catalunya
- Investigators
- Josep Maria Badia Perez, PH. D, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574090
- Sponsor's protocol ID
- 1234
- Acronym
- PROTOP
- Status last verified
- Jun 2023
- First submitted
- 30 May 2018
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
National Nosocomial Infections Surveillance (NNIS) report, data summary from October 1986-April 1996, issued May 1996. A report from the National Nosocomial Infections Surveillance (NNIS) System. Am J Infect Control. 1996 Oct;24(5):380-8. No abstract available.
PubMed 8902113Anderson DJ, Sexton DJ, Kanafani ZA, Auten G, Kaye KS. Severe surgical site infection in community hospitals: epidemiology, key procedures, and the changing prevalence of methicillin-resistant Staphylococcus aureus. Infect Control Hosp Epidemiol. 2007 Sep;28(9):1047-53. doi: 10.1086/520731. Epub 2007 Jul 12.
PubMed 17932825Simmons BP. Cdc guidelines on infection control. Infect Control. 1982 Mar-Apr;3(2 Suppl):187-96. doi: 10.1017/s0195941700056721. No abstract available.
PubMed 6918373Charalambous CP, Tryfonidis M, Swindell R, Lipsett AP. When should old therapies be abandoned? A modern look at old studies on topical ampicillin. J Infect. 2003 Oct;47(3):203-9. doi: 10.1016/s0163-4453(03)00071-9.
PubMed 12963381Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Chura JC, Boyd A, Argenta PA. Surgical site infections and supplemental perioperative oxygen in colorectal surgery patients: a systematic review. Surg Infect (Larchmt). 2007 Aug;8(4):455-61. doi: 10.1089/sur.2006.034.
PubMed 17883362Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.
PubMed 1656747Friberg O, Svedjeholm R, Soderquist B, Granfeldt H, Vikerfors T, Kallman J. Local gentamicin reduces sternal wound infections after cardiac surgery: a randomized controlled trial. Ann Thorac Surg. 2005 Jan;79(1):153-61; discussion 161-2. doi: 10.1016/j.athoracsur.2004.06.043.
PubMed 15620935Lazar HL, Ketchedjian A, Haime M, Karlson K, Cabral H. Topical vancomycin in combination with perioperative antibiotics and tight glycemic control helps to eliminate sternal wound infections. J Thorac Cardiovasc Surg. 2014 Sep;148(3):1035-8; 1038-40. doi: 10.1016/j.jtcvs.2014.06.045. Epub 2014 Jul 2.
PubMed 25129595Garner JS. CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infect Control. 1986 Mar;7(3):193-200. doi: 10.1017/s0195941700064080. No abstract available.
PubMed 3633903Abdullah KG, Attiah MA, Olsen AS, Richardson A, Lucas TH. Reducing surgical site infections following craniotomy: examination of the use of topical vancomycin. J Neurosurg. 2015 Dec;123(6):1600-4. doi: 10.3171/2014.12.JNS142092. Epub 2015 Jun 19.
PubMed 26090835Kang DG, Holekamp TF, Wagner SC, Lehman RA Jr. Intrasite vancomycin powder for the prevention of surgical site infection in spine surgery: a systematic literature review. Spine J. 2015 Apr 1;15(4):762-70. doi: 10.1016/j.spinee.2015.01.030. Epub 2015 Jan 28.
PubMed 25637469Kirby JP, Mazuski JE. Prevention of surgical site infection. Surg Clin North Am. 2009 Apr;89(2):365-89, viii. doi: 10.1016/j.suc.2009.01.001.
PubMed 19281889Krukowski ZH, Irwin ST, Denholm S, Matheson NA. Preventing wound infection after appendicectomy: a review. Br J Surg. 1988 Oct;75(10):1023-33. doi: 10.1002/bjs.1800751023.
PubMed 3064867Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
PubMed 10219875
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03574090
- Acronym / sponsor ID
- PROTOP / 1234
- Conditions
- Surgical Wound Infection, Postoperative Wound Infection, Postoperative Wound Infection Superficial Incisional, Preventive Therapy
- Keywords
- topical antibiotic, surgical wound infection, prevention of surgical wound infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Hospital de Granollers
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 11 Jun 2023 (actual)
- First posted
- 29 Jun 2018 (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.
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.
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 |
|---|---|---|
| amoxicillin clavulanate | Experimental | Drug: Amoxicillin Clavulanate, Drug: Physiological Saline1000 mg amoxicillin and potassium clavulanate equivalent to 200mg of clavulanic acid. administered topically and dissolved in 500 ml 0.9% Physiological Serum. |
| Physiological Saline | Active comparator | Drug: Physiological Saline500 milliliters of 0.9% Physiological Serum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Amoxicillin ClavulanateAlso: 1000 mg amoxicillin and 200mg clavulanic acid.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. | Drug | amoxicillin clavulanate |
| Physiological SalineAlso: 500 milliliters of 0.9% Physiological SerumTo 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. | Drug | Physiological Saline, amoxicillin clavulanate |
Primary outcome
Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI
Time frame: 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
3 secondary outcomes
reduction of hospital stay
Time frame: 30 days
Bacterial charge
Time frame: 30 days
Bacterial resistance
Time frame: 30 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 13 Jun 2023.
- Results publication: PubMed 8902113National Nosocomial Infections Surveillance (NNIS) report, data summary from October 1986-April 1996, issued May 1996. A report from the National Nosocomial Infections Surveillance (NNIS) System. Am J Infect Control. 1996 Oct;24(5):380-8. No abstract available.
- Results publication: PubMed 17932825Anderson DJ, Sexton DJ, Kanafani ZA, Auten G, Kaye KS. Severe surgical site infection in community hospitals: epidemiology, key procedures, and the changing prevalence of methicillin-resistant Staphylococcus aureus. Infect Control Hosp Epidemiol. 2007 Sep;28(9):1047-53. doi: 10.1086/520731. Epub 2007 Jul 12.
- Results publication: PubMed 6918373Simmons BP. Cdc guidelines on infection control. Infect Control. 1982 Mar-Apr;3(2 Suppl):187-96. doi: 10.1017/s0195941700056721. No abstract available.
- Results publication: PubMed 12963381Charalambous CP, Tryfonidis M, Swindell R, Lipsett AP. When should old therapies be abandoned? A modern look at old studies on topical ampicillin. J Infect. 2003 Oct;47(3):203-9. doi: 10.1016/s0163-4453(03)00071-9.
- Results publication: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Results publication: PubMed 17883362Chura JC, Boyd A, Argenta PA. Surgical site infections and supplemental perioperative oxygen in colorectal surgery patients: a systematic review. Surg Infect (Larchmt). 2007 Aug;8(4):455-61. doi: 10.1089/sur.2006.034.
- Results publication: PubMed 1656747Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.
- Results publication: PubMed 15620935Friberg O, Svedjeholm R, Soderquist B, Granfeldt H, Vikerfors T, Kallman J. Local gentamicin reduces sternal wound infections after cardiac surgery: a randomized controlled trial. Ann Thorac Surg. 2005 Jan;79(1):153-61; discussion 161-2. doi: 10.1016/j.athoracsur.2004.06.043.
- Results publication: PubMed 25129595Lazar HL, Ketchedjian A, Haime M, Karlson K, Cabral H. Topical vancomycin in combination with perioperative antibiotics and tight glycemic control helps to eliminate sternal wound infections. J Thorac Cardiovasc Surg. 2014 Sep;148(3):1035-8; 1038-40. doi: 10.1016/j.jtcvs.2014.06.045. Epub 2014 Jul 2.
- Results publication: PubMed 3633903Garner JS. CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infect Control. 1986 Mar;7(3):193-200. doi: 10.1017/s0195941700064080. No abstract available.
- Results publication: PubMed 26090835Abdullah KG, Attiah MA, Olsen AS, Richardson A, Lucas TH. Reducing surgical site infections following craniotomy: examination of the use of topical vancomycin. J Neurosurg. 2015 Dec;123(6):1600-4. doi: 10.3171/2014.12.JNS142092. Epub 2015 Jun 19.
- Results publication: PubMed 25637469Kang DG, Holekamp TF, Wagner SC, Lehman RA Jr. Intrasite vancomycin powder for the prevention of surgical site infection in spine surgery: a systematic literature review. Spine J. 2015 Apr 1;15(4):762-70. doi: 10.1016/j.spinee.2015.01.030. Epub 2015 Jan 28.
- VINCatLink provided by the sponsor.
- health preventionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 Perez, PH. D study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin Clavulanate and Physiological Saline in people with Surgical Wound Infection and Postoperative Wound Infection, run by Universitat Internacional de Catalunya 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 3 inclusion and 6 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 13 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluation of the effect of topical antibiotic prophylaxis on the incidence of SSI (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574090, which also lists 47 linked publications.
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 Jun 2023.