Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries
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| ClinicalTrials.gov Identifier: NCT03859908 |
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Recruitment Status :
Recruiting
First Posted : March 1, 2019
Last Update Posted : April 9, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Surgical Site Infection | Drug: Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML Drug: Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 964 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Pragmatic, randomized controlled trial of two substances |
| Masking: | Single (Participant) |
| Masking Description: | Participant will be randomized through a selection of a sealed envelope with computer generated random numbers by the Operating Room nurse, and the substance will be applied when participant will be already with anesthesia |
| Primary Purpose: | Prevention |
| Official Title: | Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery |
| Actual Study Start Date : | April 5, 2019 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | September 2021 |
| Arm | Intervention/treatment |
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Experimental: Iodine-Povacrylex Alcohol
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
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Drug: Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML
As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
Other Name: [DuraPrep] |
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Active Comparator: Chlorhexidine Alcohol
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
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Drug: Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML
As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
Other Names:
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- 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.
- Superficial surgical site infection [ Time Frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date) ]Infection that occurs after surgery and involves only skin and subcutaneous tissue of the incision
- Deep surgical site infection [ Time Frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date) ]Infection that occurs after surgery that involves deep soft tissues of the incision (for example, fascial and muscle layers)
- Organ/space SSI [ Time Frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date) ]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
- Skin reaction [ Time Frame: Date of event occurs within 7 days after surgery (where day 1= the procedure date ]Any kind of irritation or skin reaction after applying the solution
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Elective surgery categorized as clean contaminated surgery Major abdominal
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Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859908
| Contact: Maria-Virginia Rodriguez, MD, FACS | +50371902009 | rodriguezvir_cirug@yahoo.com.mx |
| El Salvador | |
| Hospital Nacional Rosales | Recruiting |
| San Salvador, El Salvador, 0000 | |
| Contact: Salvador F Salgado Rauda, MD, FACS +50378377532 salgadosalvador@gmail.com | |
| Contact: Irene B Arevalo, MD 50372643913 ifran1792@gmail.com | |
| Principal Investigator: Salvador F Salgado Rauda, MD, FACS | |
| Sub-Investigator: Irene B Arevalo, MD | |
| Sub-Investigator: Dinora B Mancia, MD | |
| Principal Investigator: | Maria-Virginia Rodriguez, MD, FACS | Universidad de El Salvador |
| Responsible Party: | Maria-Virginia Rodriguez Funes, Clinical research coordinator, Universidad de El Salvador |
| ClinicalTrials.gov Identifier: | NCT03859908 |
| Other Study ID Numbers: |
Iodine alcohol Trial CNEIS/2018/049 ( Other Identifier: Comite Nacional de Etica de Investigacion en Salud ) |
| First Posted: | March 1, 2019 Key Record Dates |
| Last Update Posted: | April 9, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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surgery infection antisepsis |
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Surgical Wound Infection Infection Wound Infection Postoperative Complications Pathologic Processes Ethanol Chlorhexidine |
Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Disinfectants Dermatologic Agents |