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The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the checklist to prevent MRSA SSIs among Veterans undergoing TJA or cardiac surgery, and 2) to assess barriers and facilitators to checklist implementation.
Hypotheses:
Aims and Design: Methicillin-resistant Staphylococcus aureus (MRSA), accounts for an estimated 94,000 invasive infections and 19,000 deaths annually in the U.S. In order to prevent MRSA infections among Veterans, the VA successfully implemented the VA MRSA Prevention Initiative that has reduced patient-to-patient transmission of MRSA. However, this Initiative does not prevent most MRSA surgical site infections (SSIs) because MRSA SSIs are usually caused by MRSA transferring from a patient's nose to their own surgical incision site. Cardiac surgery and total joint arthroplasty (TJA; e.g. hip or knee surgery) are among the most common operations performed by the VA and are associated with particularly high clinical and economic impact. In order to eliminate MRSA SSIs in the VA, the study group developed a checklist based on a meta-analysis of studies that assessed methods to prevent gram-positive SSIs among TJA and cardiac surgery patients. This SSI Checklist includes preoperatively testing a surgical patient's nose for asymptomatic MRSA colonization. If the patient is MRSA colonized, s/he will be treated with prophylactic nasal mupirocin ointment, chlorhexidine gluconate baths, and antibiotic prophylaxis with both cefazolin and vancomycin. The SSI Checklist will be implemented in 10 VA Medical Centers (VAMCs). A high-quality quasi-experimental study, with a qualitative process evaluation will be performed to assess the SSI Checklist. The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the checklist to prevent MRSA SSIs among Veterans undergoing TJA or cardiac surgery, and 2) to assess barriers and facilitators to checklist implementation.
Methods: This study includes both quantitative and qualitative components. In the quantitative component, the SSI Checklist will be implemented in 10 VAMCs for 3 years and outcomes will be compared between the intervention group and two control groups: 1) 5 years of historic data from the same 10 VAMCs, 2) 8 years (5 historic year and 3 intervention years) of concurrent data from other VAMCs that did not implement the SSI Checklist. Study endpoints will include: 1) MRSA SSIs as defined by the Centers for Disease Control and Prevention (CDC); 2) SSIs caused by other pathogens; 3) cost per SSI prevented, cost per life-saved, cost per MRSA SSI prevented and cost per quality-adjusted life-year (QALY) saved. VA databases including VA National Surgical Quality Improvement Program (VASQIP), VA Decision Support System, VA Inpatient Evaluation Center (IPEC) and Veterans' Informatics & Computing Infrastructure (VINCI) will be used to collect data. Time series analysis and linear mixed effects models will be used for the statistical analysis. In the qualitative component, a process evaluation will be conducted at 6 different VAMCs, which includes collecting data before, during and after implementation, to examine the contextual factors and stakeholder perspectives that influence adoption of the SSI Checklist. Observations and semi-structured interviews will be conducted in Years 1 and 3, along with thematic content analysis, to examine facilitators and barriers to the implementation at the different study sites. The Consolidated Framework for Implementation Research will be used to guide the process evaluation and provide the foundation for a systematic evaluation of local contextual factors that influence implementation of the SSI Checklist. The products of this study include a validated SSI Checklist, a business-case analysis, an implementation toolkit, and a team experienced in checklist implementation for prevention of infections. At the end of this study period, the study team will meet with operational partners including National Infectious Disease Program Office (NIDS) and the MRSA / Multidrug-resistant Program Office (MDRO), and the National Center for Occupational Health and Infection Control (COHIC) to discuss implementing this checklist nationwide as part of the VA MRSA Prevention Initiative. This study has high potential to significantly decrease SSI, and in turn morbidity and mortality due to SSIs, in our Nation's Veterans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Site Infection Checklist | Experimental | Patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
Patient has a known negative Staph aureus pre-op screening result:
Patient was not screened or results are unknown at time of surgery:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin | Drug | Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Superficial and Deep/Organ Space MRSA Infections Within 90 Days | Participants with superficial and deep/organ space MRSA infections, 90 days postoperatively, as measured by VA electronic health data. | 90 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Superficial and Deep/Organ Space MRSA Infections Within 1 Year | The investigators chose 90-days rather than 1 year for the primary outcome measure since not all patients in the study will be able to be followed for 1 year due to the timing of the study. However, since the investigators will be able to follow 83% of the cohort for 1-year post-operatively, the investigators will perform this secondary analysis in which the investigators will include only patients who were followed for one year. However, it is unlikely that the 90-day analysis and 1 year analysis will differ significantly because over 75% of SSIs are detected within 30 days, in fact most SSI manifest within 22 days. |
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Inclusion Criteria:
Retrospective Control Group Inclusion Criteria:
Concurrent Non-equivalent Control Group Inclusion Criteria:
Exclusion Criteria:
For All Patient Groups:
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| Name | Affiliation | Role |
|---|---|---|
| Eli N. Perencevich, MD MS BS | Iowa City VA Health Care System, Iowa City, IA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami VA Healthcare System, Miami, FL | Miami | Florida | 33125 | United States | ||
| Iowa City VA Health Care System, Iowa City, IA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28593043 | Background | Carrel M, Goto M, Schweizer ML, David MZ, Livorsi D, Perencevich EN. Diffusion of clindamycin-resistant and erythromycin-resistant methicillin-susceptible Staphylococcus aureus (MSSA), potential ST398, in United States Veterans Health Administration Hospitals, 2003-2014. Antimicrob Resist Infect Control. 2017 Jun 5;6:55. doi: 10.1186/s13756-017-0212-1. eCollection 2017. | |
| 28873140 |
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For the "Concurrent Non-equivalent Control Group" there were not patients identified in VA databases as undergoing total joint arthroplasty or cardiac surgery at VA Medical Centers who were not included in the intervention group during the years of the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Retrospective Control Group | Retrospective Control Group Inclusion Criteria: • Patients identified in VA databases (e.g. VASQIP) by ICD-9 procedure codes as undergoing total joint arthroplasty or cardiac surgery at the 11 intervention VA Medical Centers during the 5 year preintervention period (2008-2013) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Retrospective Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2021 |
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| Chlorhexidine gluconate | Drug | Patients that are MRSA or MSSA positive or have unknown status will bathe in CHG daily x 5 days. Patients that are MRSA or MSSA negative will bathe with CHG the night before and morning of surgery. |
|
|
| Cefazolin | Drug | All patients will receive Cefazolin during surgery |
|
|
| Vancomycin | Drug | Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery. |
|
|
| Nasal Povidone Iodine | Drug | The purpose of this research is to evaluate a SSI checklist. This checklist includes decolonizing a patient's nose and skin and optimizing antibiotics prior to surgery. At the time that we wrote it, the predominate product to decolonize patient's noses was mupirocin. However, in 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist. |
|
|
| one year postoperatively |
| Participants Compliant With the Entire Pre-surgical Bundle and Individual Bundle Components | This will be established electronically, through measurement of mupirocin prescription, CHG prescription and swab collection, as well as utilizing the compliance information collected on patient intake on the day of surgery. | 30-days pre-surgery to day of surgery |
| Length of Postoperative Stay | Duration of postoperative stay, an expected average of 3 days. | Duration of postoperative stay, an expected average of 3 days |
| All-cause Mortality | All-cause mortality, Up to 1-year post-surgery. | Up to 1-year post-surgery |
| Readmission | Readmission, 90-days postsurgery. | 90-days postsurgery |
| Participants With Mupirocin and Chlorhexidine Resistant MRSA Positive Bacterial Isolates | The investigators will test bacterial isolates from MRSA positive patients at the 11 interventions sites. The VA is mandated to take nasal swabs from each patient preoperatively. For those patients who are MRSA positive, the investigators will have the bacterial isolates sent to the Iowa City site to be tested for resistance to mupirocin and CHG. The investigators will also collect bacterial isolates from patients who experience surgical site infections during the study. These isolates will also be tested for mupirocin and CHG resistance. The purpose of this testing is to a) ensure the investigators' study checklist does not cause mupirocin or CHG resistance by b) determining if resistance was present at the initial nasal swab, or if resistance occurred after performance of study checklist. | 30-days pre-surgery to 90-days post-surgery |
| Iowa City |
| Iowa |
| 52246-2208 |
| United States |
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417 | United States |
| Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE | Omaha | Nebraska | 68105-1873 | United States |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| South Texas Health Care System, San Antonio, TX | San Antonio | Texas | 78229 | United States |
| VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | 84148 | United States |
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin | 53705 | United States |
| Background |
| Goto M, Schweizer ML, Vaughan-Sarrazin MS, Perencevich EN, Livorsi DJ, Diekema DJ, Richardson KK, Beck BF, Alexander B, Ohl ME. Association of Evidence-Based Care Processes With Mortality in Staphylococcus aureus Bacteremia at Veterans Health Administration Hospitals, 2003-2014. JAMA Intern Med. 2017 Oct 1;177(10):1489-1497. doi: 10.1001/jamainternmed.2017.3958. |
| 25979001 | Background | Safdar N, Perencevich E. Crossing the quality chasm for Clostridium difficile infection prevention. BMJ Qual Saf. 2015 Jul;24(7):409-11. doi: 10.1136/bmjqs-2015-004344. Epub 2015 May 15. No abstract available. |
| 31737738 | Result | Singh N, Nair R, Goto M, Carvour ML, Carnahan R, Field EH, Lenert P, Vaughan-Sarrazin M, Schweizer ML, Perencevich EN. Risk of Recurrent Staphylococcus aureus Prosthetic Joint Infection in Rheumatoid Arthritis Patients-A Nationwide Cohort Study. Open Forum Infect Dis. 2019 Oct 19;6(11):ofz451. doi: 10.1093/ofid/ofz451. eCollection 2019 Nov. |
| Result | Pfeiffer CD, Williams HB, Flegal H, Klutts JS, Evans M, Jones MM. 493. Laboratory Evaluation and Epidemiology of Carbapenemase-Producing Carbapenem-Resistant Enterobacteriaceae in Department of Veterans Affairs, 2017. [Abstract]. Open forum infectious diseases. 2019 Oct 23; 6(Supplement_2):S240-S241. |
| 33618788 | Result | Suzuki H, Clore GS, Perencevich EN, Hockett-Sherlock SM, Goto M, Nair R, Branch-Elliman W, Richardson KK, Gupta K, Beck BF, Alexander B, Balkenende EC, Schweizer ML. Development of a fully automated surgical site infection detection algorithm for use in cardiac and orthopedic surgery research. Infect Control Hosp Epidemiol. 2021 Oct;42(10):1215-1220. doi: 10.1017/ice.2020.1387. Epub 2021 Feb 23. |
| 37471087 | Result | Suzuki H, Perencevich EN, Hockett Sherlock S, Clore GS, O'Shea AMJ, Forrest GN, Pfeiffer CD, Safdar N, Crnich C, Gupta K, Strymish J, Lira GB, Bradley S, Cadena-Zuluaga J, Rubin M, Bittner M, Morgan D, DeVries A, Miell K, Alexander B, Schweizer ML. Implementation of a Prevention Bundle to Decrease Rates of Staphylococcus aureus Surgical Site Infection at 11 Veterans Affairs Hospitals. JAMA Netw Open. 2023 Jul 3;6(7):e2324516. doi: 10.1001/jamanetworkopen.2023.24516. |
| 36925849 | Derived | Hockett Sherlock S, Goedken CC, Balkenende EC, Dukes KC, Perencevich EN, Reisinger HS, Forrest GN, Pfeiffer CD, West KA, Schweizer M. Strategies for the implementation of a nasal decolonization intervention to prevent surgical site infections within the Veterans Health Administration. Front Health Serv. 2022 Aug 17;2:920830. doi: 10.3389/frhs.2022.920830. eCollection 2022. |
| Surgical Site Infection Checklist |
At these VA Facilities, if patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
At these VA facilities, if patient has a known negative Staph aureus pre-op screening result:
At these VA facilities, if patient was not screened or results are unknown at time of surgery:
Nasal Povidone Iodine: In 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Intervention Period |
|
Baseline Data were not collected from participants in the "Retrospective Control Group" Arm
| ID | Title | Description |
|---|---|---|
| BG000 | Surgical Site Infection Checklist | At these VA Facilities, if patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
At these VA facilities, if patient has a known negative Staph aureus pre-op screening result:
At these VA facilities, if patient was not screened or results are unknown at time of surgery:
Nasal Povidone Iodine: replace mupirocin with povidone-iodine at 3 medical centers to assess if this overcomes the barriers to our SSI checklist. |
| Units | Counts |
|---|---|
| Participants |
|
| VA facilities |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age data were not collected from any participant. | Count of Units | VA facilities | VA facilities |
|
| |||||||||||||||||||||||
| Sex: Female, Male | Sex data were not collected from any participant. | Count of Units | VA facilities | VA facilities |
|
| |||||||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
| ||||||||||||||||||||||||
| Region of Enrollment | Number | participants | Participants |
|
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Superficial and Deep/Organ Space MRSA Infections Within 90 Days | Participants with superficial and deep/organ space MRSA infections, 90 days postoperatively, as measured by VA electronic health data. | Patients undergoing surgery at the 11 VA facilities during intervention | Posted | Number | participants | 90 days postoperatively | VA facilities | VA facilities |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Superficial and Deep/Organ Space MRSA Infections Within 1 Year | The investigators chose 90-days rather than 1 year for the primary outcome measure since not all patients in the study will be able to be followed for 1 year due to the timing of the study. However, since the investigators will be able to follow 83% of the cohort for 1-year post-operatively, the investigators will perform this secondary analysis in which the investigators will include only patients who were followed for one year. However, it is unlikely that the 90-day analysis and 1 year analysis will differ significantly because over 75% of SSIs are detected within 30 days, in fact most SSI manifest within 22 days. | Patients undergoing surgeries at 11 VA facilities during intervention period; data reported is at 90 days | Posted | Number | participants | one year postoperatively | VA facilities | VA facilities |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants Compliant With the Entire Pre-surgical Bundle and Individual Bundle Components | This will be established electronically, through measurement of mupirocin prescription, CHG prescription and swab collection, as well as utilizing the compliance information collected on patient intake on the day of surgery. | Because facilities did not collect this data, this measure was not conducted and data will not be collected in the future. | Posted | 30-days pre-surgery to day of surgery | VA Facilities | VA Facilities |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Postoperative Stay | Duration of postoperative stay, an expected average of 3 days. | Due to funding constraints, this measure was not conducted and data will not be collected in the future. | Posted | Duration of postoperative stay, an expected average of 3 days | VA facilities | VA facilities |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All-cause Mortality | All-cause mortality, Up to 1-year post-surgery. | Due to funding constraints, this measure was not conducted and data will not be collected in the future. | Posted | Up to 1-year post-surgery | VA facilities | VA facilities |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Readmission | Readmission, 90-days postsurgery. | Due to funding constraints, this measure was not conducted and data will not be collected in the future. | Posted | 90-days postsurgery | VA facilities | VA facilities |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Mupirocin and Chlorhexidine Resistant MRSA Positive Bacterial Isolates | The investigators will test bacterial isolates from MRSA positive patients at the 11 interventions sites. The VA is mandated to take nasal swabs from each patient preoperatively. For those patients who are MRSA positive, the investigators will have the bacterial isolates sent to the Iowa City site to be tested for resistance to mupirocin and CHG. The investigators will also collect bacterial isolates from patients who experience surgical site infections during the study. These isolates will also be tested for mupirocin and CHG resistance. The purpose of this testing is to a) ensure the investigators' study checklist does not cause mupirocin or CHG resistance by b) determining if resistance was present at the initial nasal swab, or if resistance occurred after performance of study checklist. | Due to funding constraints, this measure was not conducted and data will not be collected in the future. | Posted | 30-days pre-surgery to 90-days post-surgery | VA Facilities | VA Facilities |
|
30 days
Death and serious adverse events due to study product were monitored within hospital admission. Other non-serious adverse events were not assessed for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgical Site Infection Checklist | Patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
Patient has a known negative Staph aureus pre-op screening result:
Patient was not screened or results are unknown at time of surgery:
Nasal Povidone Iodine: In 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist. | 0 | 7,793 | 0 | 7,793 | 0 | 0 |
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Secondary Outcomes measures data was not available due to funding constraints.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eli N Perencevich, MD MS BS | Iowa City VA Health Care System, Iowa City, IA | 319-338-0581 | 3535 | eli.perencevich@va.gov |
| Oct 20, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016712 | Mupirocin |
| C010882 | chlorhexidine gluconate |
| D002864 | Chromogranins |
| D002437 | Cefazolin |
| D014640 | Vancomycin |
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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|
| Title | Measurements |
|---|---|
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