Surgical Site InfectionPhase 4NCT03859908
Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries
A Phase 4 study testing Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML and Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML in people with Surgical Site Infection, run by Universidad de El Salvador at 1 site in El Salvador.
Trial summary
Pragmatic randomized clinical trial comparing Iodine Povacrylex based on alcohol to Chlorhexidine also based on alcohol in efficacy and security to diminish frequency of surgical site infections in major abdominal elective clean contaminated wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML and Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEl Salvador
- Study dates
- 5 Apr 2019to 27 Jan 2021
- 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
- Elective surgery categorized as clean contaminated surgery Major abdominal
- -
Who cannot join
- American Society of Anesthesia III-IV
- Laparoscopic cholecystectomy
- Inguinal hernias classification I, II
- Obese subjects with Body Mass Index more than 35 or malnourished
- immunocompromised subjects
- neoplasia Preoperative hospital stay more than 7 days allergic to any of the solutions used in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery
Pragmatic randomized clinical trial comparing Iodine Povacrylex based on alcohol to Chlorhexidine also based on alcohol in efficacy and security to diminish frequency of surgical site infections in major abdominal elective clean contaminated wounds. Will be held in a third level university, high volume national public hospital in San Salvador, El Salvador.
Read the detailed description
Preoperative antiseptic Chlorhexidine based on alcohol has been established as gold standard of care for clean contaminated wounds. It was compared to Iodine solutions non-alcohol based. There is a question about alcohol based solution was a confounder in the comparison. The aim of this study is to compare the efficacy of both solutions alcohol based, 0.7% iodine povacrylex plus 74% alcohol, against gluconate chlorhexidine 2% plus 70% alcohol, in clean contaminated wounds, in major abdominal elective surgeries, in a wider range than colorectal surgeries, Materials and methods. With a pragmatic randomized, phase 4, controlled clinical trial. Comparison of two antiseptic solutions, using manufacturer (3M) sterile appliers' for both products, Food and Drugs Agency approved.
Quality of data will be assured by first training all surgeons and residents besides researchers in the study protocol for protocol compliance in subject identification, randomization moment, and follow up. There is a plan for weekly monitoring of protocol compliance, and monthly data monitoring and auditing from Faculty of Medicine Research Unit.
Monitoring and auditing will comply protocol compliance and data integrity against subject's medical records and random interviews of patients in their post-surgical control.
Surgical Site Infection definitions are those taken from Centers for Disease Control definitions.
Standard Operating Procedures will be established in all moments of the trial, from subject identification, informed consent, recruitment, randomization process in the operating room, and data collection in pre specified files for data collection and data management. Protocol compliance and Standard Operating Procedures compliance will be monitored by Principal Investigator constantly. Report of adverse events will be done in accordance to Salvadoran National ethics committee Standard Operating Procedures as also any other communication such as protocol deviance or amendments. Previous research has not reported adverse events, but we will be expectant to their appearance.
Sample size was calculated for a total of 964 subjects, 482 in each group, using statistics software, were we established a statistic significant level for a bilateral hypothesis of 95% and a power of 80%, based on previous research of comparison of both solutions to get a probability of SSI of 4.2% in Chlorhexidine group against 8.6% in Iodine povacrylex group.
We will establish a strict follow up of patients in the 30 days considered as post-operative time, by enabling the whole public health system to integrate in subjects´, surgical care (primary care) to diminish the probability of missing data.
Data analysis will be done following "intention to treat" analysis principle. Primary outcome will be any kind of Surgical Site Infection, categorical variable, will be analyzed with chi square for a bilateral hypothesis, and also measure the difference with risk ratio and its 95% confidence interval.
- Conditions
- Surgical Site Infection
- Being tested
- Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML, Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML
- Keywords
- surgery, infection, antisepsis
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/MLDrug
Also called [DuraPrep]
As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/MLDrug
Also called SoluPrep, ChloraPrep
As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
| Study group | Role | What they receive |
|---|---|---|
| Iodine-Povacrylex Alcohol | Experimental | Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of Iodine-povacrylex 7mg/ml plus isopropyl alcohol 0.74 ml/ml (DuraPrep) , fabricated by 3M, as the experimental intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Centers of Disease Control Receives: Drug: Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML |
| Chlorhexidine Alcohol | Active comparator | Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of chlorhexidine 20 mg/ml plus isopropyl alcohol 0.7 ml/ml (SoluPrep), fabricated by 3M, as the control intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Center of Disease Control Receives: Drug: Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
infections of the incision or organ or space that occur after surgery.
Measured: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Secondary outcomes (4)
Superficial surgical site infection
Infection that occurs after surgery and involves only skin and subcutaneous tissue of the incision
Measured: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Deep surgical site infection
Infection that occurs after surgery that involves deep soft tissues of the incision (for example, fascial and muscle layers)
Measured: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Organ/space SSI
Infection that occurs after surgery that involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during the operative procedure
Measured: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Skin reaction
Any kind of irritation or skin reaction after applying the solution
Measured: Date of event occurs within 7 days after surgery (where day 1= the procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start5 Apr 2019
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Why it stopped: Difficulties for recruitment due to COVID-19 pandemia and expiration of the material
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, randomized controlled trial of two substances
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de El Salvador
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria-Virginia Rodriguez Funes, Universidad de El Salvador
- Investigators
- Maria-Virginia Rodriguez, MD, FACS, Principal investigator, Universidad de El Salvador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859908
- Sponsor's protocol ID
- Iodine alcohol Trial
- Other IDs
- CNEIS/2018/049
- Status last verified
- May 2023
- First submitted
- 26 Feb 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: If we decide to share IPD, it will be: study protocol, statistical analysis. Criteria to share: for systematic reviews we could share also individual data collected, after the study is published. The study was stopped for recruitment due to COVID-19 emergency and elective surgeries diminished, and then the product used expired. Couldn't achieve not even 2% of Sample size
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery
- ClinicalTrials.gov ID
- NCT03859908
- Acronym / sponsor ID
- Iodine alcohol Trial
- Conditions
- Surgical Site Infection
- Keywords
- surgery, infection, antisepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties for recruitment due to COVID-19 pandemia and expiration of the material
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidad de El SalvadorUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 1 Mar 2019 (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.
Pragmatic randomized clinical trial comparing Iodine Povacrylex based on alcohol to Chlorhexidine also based on alcohol in efficacy and security to diminish frequency of surgical site infections in major abdominal elective clean contaminated wounds. Will be held in a third level university, high volume national public hospital in San Salvador, El Salvador.
Detailed description
Preoperative antiseptic Chlorhexidine based on alcohol has been established as gold standard of care for clean contaminated wounds. It was compared to Iodine solutions non-alcohol based. There is a question about alcohol based solution was a confounder in the comparison. The aim of this study is to compare the efficacy of both solutions alcohol based, 0.7% iodine povacrylex plus 74% alcohol, against gluconate chlorhexidine 2% plus 70% alcohol, in clean contaminated wounds, in major abdominal elective surgeries, in a wider range than colorectal surgeries, Materials and methods. With a pragmatic randomized, phase 4, controlled clinical trial. Comparison of two antiseptic solutions, using manufacturer (3M) sterile appliers' for both products, Food and Drugs Agency approved.
Quality of data will be assured by first training all surgeons and residents besides researchers in the study protocol for protocol compliance in subject identification, randomization moment, and follow up. There is a plan for weekly monitoring of protocol compliance, and monthly data monitoring and auditing from Faculty of Medicine Research Unit.
Monitoring and auditing will comply protocol compliance and data integrity against subject's medical records and random interviews of patients in their post-surgical control.
Surgical Site Infection definitions are those taken from Centers for Disease Control definitions.
Standard Operating Procedures will be established in all moments of the trial, from subject identification, informed consent, recruitment, randomization process in the operating room, and data collection in pre specified files for data collection and data management. Protocol compliance and Standard Operating Procedures compliance will be monitored by Principal Investigator constantly. Report of adverse events will be done in accordance to Salvadoran National ethics committee Standard Operating Procedures as also any other communication such as protocol deviance or amendments. Previous research has not reported adverse events, but we will be expectant to their appearance.
Sample size was calculated for a total of 964 subjects, 482 in each group, using statistics software, were we established a statistic significant level for a bilateral hypothesis of 95% and a power of 80%, based on previous research of comparison of both solutions to get a probability of SSI of 4.2% in Chlorhexidine group against 8.6% in Iodine povacrylex group.
We will establish a strict follow up of patients in the 30 days considered as post-operative time, by enabling the whole public health system to integrate in subjects´, surgical care (primary care) to diminish the probability of missing data.
Data analysis will be done following "intention to treat" analysis principle. Primary outcome will be any kind of Surgical Site Infection, categorical variable, will be analyzed with chi square for a bilateral hypothesis, and also measure the difference with risk ratio and its 95% confidence interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pragmatic, randomized controlled trial of two substances
| Arm | Type | Receives |
|---|---|---|
| Iodine-Povacrylex Alcohol | Experimental | Drug: Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/MLIodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of Iodine-povacrylex 7mg/ml plus isopropyl alcohol 0.74 ml/ml (DuraPrep) , fabricated by 3M, as the experimental intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Centers of Disease Control |
| Chlorhexidine Alcohol | Active comparator | Drug: Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/MLChlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of chlorhexidine 20 mg/ml plus isopropyl alcohol 0.7 ml/ml (SoluPrep), fabricated by 3M, as the control intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Center of Disease Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective surgery categorized as clean contaminated surgery Major abdominal
- -
Key exclusion criteria (6 listed)
- American Society of Anesthesia III-IV
- Laparoscopic cholecystectomy
- Inguinal hernias classification I, II
- Obese subjects with Body Mass Index more than 35 or malnourished
- immunocompromised subjects
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 |
|---|---|---|
| Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/MLAlso: [DuraPrep]As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis | Drug | Iodine-Povacrylex Alcohol |
| Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/MLAlso: SoluPrep, ChloraPrepAs preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis | Drug | Chlorhexidine Alcohol |
Primary outcome
Surgical site infection
Time frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
infections of the incision or organ or space that occur after surgery.
4 secondary outcomes
Superficial surgical site infection
Time frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Deep surgical site infection
Time frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Organ/space SSI
Time frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Skin reaction
Time frame: Date of event occurs within 7 days after surgery (where day 1= the procedure date
Results and safety
The study was stopped early (reason given: Difficulties for recruitment due to COVID-19 pandemia and expiration of the material). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No. If we decide to share IPD, it will be: study protocol, statistical analysis. Criteria to share: for systematic reviews we could share also individual data collected, after the study is published. The study was stopped for recruitment due to COVID-19 emergency and elective surgeries diminished, and then the product used expired. Couldn't achieve not even 2% of Sample size
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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.
Maria-Virginia Rodriguez, MD, FACS principal investigator
Universidad de El Salvador
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 Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML and Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML in people with Surgical Site Infection, run by Universidad de El Salvador at 1 site in El Salvador.
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 2 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: stopped early, as of the sponsor's last update on 10 May 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 El Salvador. 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 was stopped early (reason given: Difficulties for recruitment due to COVID-19 pandemia and expiration of the material). Results are not available in the source record.
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 (time frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)). 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 10 May 2023.