Surgical Wound InfectionNCT01924884
Surgical Site Infection Rate After Intra-Abdominal Surgery Using Negative Pressure Wound Therapy at Initial Closure
An observational study of Surgical Wound Infection and Wound; Abdomen, Abdominal Wall, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this study is to present a large single-institution experience reporting surgical site infection rates in patients who have undergone intra-abdominal surgery followed by wound closure with Negative Pressure Wound Therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection, Wound; Abdomen, Abdominal Wall, Surgery
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 2019
- Phase
- Observational
- 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
Study population: All patients greater than or equal to 18 years of age undergoing intra-abdominal surgery at Johns Hopkins Hospital by Dr. Frederic Eckhauser. Both men and women and members of all races and ethnic groups are eligible.
Who may be able to join
- Greater than or equal to 18 years of age
- Undergoing intra-abdominal surgery at Johns Hopkins Hospital by Dr. Frederic Eckhauser
Who cannot join
- Less than 18 years of age
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Surgical Site Infection (SSI) Rate After Intra-Abdominal Surgery Using Negative Pressure Wound Therapy (NPWT) at Initial Closure
The goal of this study is to present a large single-institution experience reporting surgical site infection rates in patients who have undergone intra-abdominal surgery followed by wound closure with Negative Pressure Wound Therapy. A retrospective review of patients' charts will be conducted to analyze surgical site infection rates between wound closure with and without Negative Pressure Wound Therapy (NPWT). American College of Surgeons National Quality Improvement Program data from previous standard of care (primary closure after colorectal surgery) will be used for comparison with newly adopted standard of care treatment regimen (wound closure with NPWT).
Data on patients who underwent intra-abdominal surgery will be retrospectively collected and a database will be created. These individuals will be identified through medical records and recontacted by mail and/or phone to collect study data.
Finally, patients newly referred to the Principal Investigator for intra-abdominal surgery will be enrolled in the database. After giving informed consent, data on surgical site infection rates and outcomes will be collected. Longitudinal outcomes will be assessed at 30 days, 6 months, and 12 months post-operatively. These patients' outcomes will be compared to a group of patients treated by the Principal Investigator who also underwent intra-abdominal surgery without Negative Pressure Wound Therapy. We hypothesize that fewer patients treated with negative pressure wound therapy following intra-abdominal surgery will develop surgical site infections than patients who had intra-abdominal surgery but were not treated with Negative Pressure Wound Therapy.
Read the detailed description
Duration of individual study participation will last approximately one year for prospectively enrolled participants. Data collection for retrospectively enrolled patients will span approximately 12 months.
Study data will not be collected on subjects until eligibility is confirmed and the patient is assigned a study number.
All information will be collected in a secure study-specific electronic registry database. The data will be reviewed for completeness and accuracy by the Principal Investigator. This is an observational registry which does not include an investigatory agent and poses minimal risk to the participants. Thus, the monitoring will be done by the study personnel - an independent board is not necessary.
This study will use the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4. Information about all adverse events, whether volunteered by the subject, discovered by the investigator, or detected through physical examination, laboratory test, or other means, will be collected, recorded, and followed as appropriate. All adverse events experienced by participants will be collected and reported from the time of consent until the Day 30 follow-up appointment, as appropriate. Thereafter, only adverse events of interest (i.e., death, additional hospitalization, surgical site infection, surgical site occurrence) will be recorded. Participants who have an ongoing adverse event related to the study procedures may continue to be periodically contacted by a member of the study staff until the event has resolved or determine to be irreversible by the principal investigator. All adverse events and serious adverse events will be reported to the Johns Hopkins Medicine Institutional Review Board.
To generate a large data set that may be used to answer various research questions, enrollment will continue for at least 10 years, generating an estimated patient sample size of n=1200. The study team anticipates enrolling 100-150 patients in the study registry per year over 10 years.
Simple descriptive statistics will be used to determine the rate of SSIs in colorectal surgery patients. This rate will be compared with the SSI rate published in literature to determine if implementation of negative pressure wound therapy wound closure following colorectal surgery decreases the rate of SSIs in colorectal surgery patients. A hypothesis test will be used to determine if there is a difference before and after adoption of negative pressure wound therapy wound closure. Enrollment of subjects over several years will enable further analyses with the possibility of stratification according to different patient characteristics.
- Keywords
- Vacuum-Assisted Closure, Topical Negative-Pressure Therapy, Negative-Pressure Dressings
- Medical subject headings
- Surgical Wound Infection, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Patients newly referred to the Principal Investigator for intra-abdominal surgery and for whom the Principal Investigator anticipates using Negative-Pressure Wound Therapy. | |
| Retrospective | Patients who underwent intra-abdominal surgery by the Principal Investigator between January 1, 2011 and May 9, 2013 will be identified through patient medical records. Living patients will be contacted via letter from the Principal Investigator introducing the study along with the study's consent form for the patients' review. Interested patients will be consented either in person at the patient's next clinic visit or via telephone by a member of the study staff. | |
| Historical Controls | Patients who underwent intra-abdominal surgery without Negative-Pressure Wound Therapy by the Principal Investigator prior to January 1, 2011 will be enrolled as Historical Controls. | |
| De-Identified Retrospective | Patients who underwent intra-abdominal surgery by the Principal Investigator between January 1, 2011 and May 9, 2013 and are deceased or do not consent to be in the study will be enrolled in the De-Identified Retrospective Case Cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection (per the 1999 Guideline for Prevention of Surgical Site Infection from the Hospital Infections Program at the National Center for Infectious Diseases, Centers for Disease Control and Prevention).
Comparing surgical site infection (per the 1999 Guideline for Prevention of Surgical Site Infection from the Hospital Infections Program at the National Center for Infectious Diseases) rates between patients treated with and without negative pressure wound therapy.
Objective: To determine if a newly adopted standard of care [negative pressure wound therapy (NPWT)] for clean, clean-contaminated, and contaminated wounds will lead to decreased rates of post-operative surgical site infection.
Measured: Up to one year
Secondary outcomes (2)
Surgical site occurrence (per the 2010 Ventral Hernia Working Group's classification and the modified hernia grading scale by Kanters et al.; 2012).
Comparing surgical site occurrence (per the 2010 Ventral Hernia Working Group's classification and the modified hernia grading scale by Kanters et al.; 2012) rates between patients treated with and without negative pressure wound therapy.
Objective: To determine if a newly adopted standard of care [negative pressure wound therapy (NPWT)] for clean, clean-contaminated, and contaminated wounds will lead to decreased rates of post-operative surgical site occurrence.
Measured: Up to one year
Quantifying post-operative morbidity and mortality rates among patients undergoing bowel surgery with or without negative pressure wound therapy.
Objective: To determine if a newly adopted standard of care [negative pressure wound therapy (NPWT)] for clean, clean-contaminated, and contaminated wounds will improve outcomes of bowel surgery patients.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Sponsor
- Investigators
- Carisa Cooney, MPH, CCRP, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924884
- Sponsor's protocol ID
- IRB00155110
- Other IDs
- NA_00052186
- Status last verified
- Jan 2020
- First submitted
- 5 Aug 2013
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pooled data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Site Infection (SSI) Rate After Intra-Abdominal Surgery Using Negative Pressure Wound Therapy (NPWT) at Initial Closure
- ClinicalTrials.gov ID
- NCT01924884
- Acronym / sponsor ID
- IRB00155110
- Keywords
- Vacuum-Assisted Closure, Topical Negative-Pressure Therapy, Negative-Pressure Dressings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- Jul 2013 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 19 Aug 2013 (estimated)
- 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 goal of this study is to present a large single-institution experience reporting surgical site infection rates in patients who have undergone intra-abdominal surgery followed by wound closure with Negative Pressure Wound Therapy. A retrospective review of patients' charts will be conducted to analyze surgical site infection rates between wound closure with and without Negative Pressure Wound Therapy (NPWT). American College of Surgeons National Quality Improvement Program data from previous standard of care (primary closure after colorectal surgery) will be used for comparison with newly adopted standard of care treatment regimen (wound closure with NPWT).
Data on patients who underwent intra-abdominal surgery will be retrospectively collected and a database will be created. These individuals will be identified through medical records and recontacted by mail and/or phone to collect study data.
Finally, patients newly referred to the Principal Investigator for intra-abdominal surgery will be enrolled in the database. After giving informed consent, data on surgical site infection rates and outcomes will be collected. Longitudinal outcomes will be assessed at 30 days, 6 months, and 12 months post-operatively. These patients' outcomes will be compared to a group of patients treated by the Principal Investigator who also underwent intra-abdominal surgery without Negative Pressure Wound Therapy. We hypothesize that fewer patients treated with negative pressure wound therapy following intra-abdominal surgery will develop surgical site infections than patients who had intra-abdominal surgery but were not treated with Negative Pressure Wound Therapy.
Detailed description
Duration of individual study participation will last approximately one year for prospectively enrolled participants. Data collection for retrospectively enrolled patients will span approximately 12 months.
Study data will not be collected on subjects until eligibility is confirmed and the patient is assigned a study number.
All information will be collected in a secure study-specific electronic registry database. The data will be reviewed for completeness and accuracy by the Principal Investigator. This is an observational registry which does not include an investigatory agent and poses minimal risk to the participants. Thus, the monitoring will be done by the study personnel - an independent board is not necessary.
This study will use the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4. Information about all adverse events, whether volunteered by the subject, discovered by the investigator, or detected through physical examination, laboratory test, or other means, will be collected, recorded, and followed as appropriate. All adverse events experienced by participants will be collected and reported from the time of consent until the Day 30 follow-up appointment, as appropriate. Thereafter, only adverse events of interest (i.e., death, additional hospitalization, surgical site infection, surgical site occurrence) will be recorded. Participants who have an ongoing adverse event related to the study procedures may continue to be periodically contacted by a member of the study staff until the event has resolved or determine to be irreversible by the principal investigator. All adverse events and serious adverse events will be reported to the Johns Hopkins Medicine Institutional Review Board.
To generate a large data set that may be used to answer various research questions, enrollment will continue for at least 10 years, generating an estimated patient sample size of n=1200. The study team anticipates enrolling 100-150 patients in the study registry per year over 10 years.
Simple descriptive statistics will be used to determine the rate of SSIs in colorectal surgery patients. This rate will be compared with the SSI rate published in literature to determine if implementation of negative pressure wound therapy wound closure following colorectal surgery decreases the rate of SSIs in colorectal surgery patients. A hypothesis test will be used to determine if there is a difference before and after adoption of negative pressure wound therapy wound closure. Enrollment of subjects over several years will enable further analyses with the possibility of stratification according to different patient characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | –Patients newly referred to the Principal Investigator for intra-abdominal surgery and for whom the Principal Investigator anticipates using Negative-Pressure Wound Therapy. |
| Retrospective | – | –Patients who underwent intra-abdominal surgery by the Principal Investigator between January 1, 2011 and May 9, 2013 will be identified through patient medical records. Living patients will be contacted via letter from the Principal Investigator introducing the study along with the study's consent form for the patients' review. Interested patients will be consented either in person at the patient's next clinic visit or via telephone by a member of the study staff. |
| Historical Controls | – | –Patients who underwent intra-abdominal surgery without Negative-Pressure Wound Therapy by the Principal Investigator prior to January 1, 2011 will be enrolled as Historical Controls. |
| De-Identified Retrospective | – | –Patients who underwent intra-abdominal surgery by the Principal Investigator between January 1, 2011 and May 9, 2013 and are deceased or do not consent to be in the study will be enrolled in the De-Identified Retrospective Case Cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients greater than or equal to 18 years of age undergoing intra-abdominal surgery at Johns Hopkins Hospital by Dr. Frederic Eckhauser. Both men and women and members of all races and ethnic groups are eligible.
Key inclusion criteria (2 listed)
- Greater than or equal to 18 years of age
- Undergoing intra-abdominal surgery at Johns Hopkins Hospital by Dr. Frederic Eckhauser
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Pregnant females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical site infection (per the 1999 Guideline for Prevention of Surgical Site Infection from the Hospital Infections Program at the National Center for Infectious Diseases, Centers for Disease Control and Prevention).
Time frame: Up to one year
Comparing surgical site infection (per the 1999 Guideline for Prevention of Surgical Site Infection from the Hospital Infections Program at the National Center for Infectious Diseases) rates between patients treated with and without negative pressure wound therapy. Objective: To determine if a newly adopted standard of care [negative pressure wound therapy (NPWT)] for clean, clean-contaminated, and contaminated wounds will lead to decreased rates of post-operative surgical site infection.
2 secondary outcomes
Surgical site occurrence (per the 2010 Ventral Hernia Working Group's classification and the modified hernia grading scale by Kanters et al.; 2012).
Time frame: Up to one year
Quantifying post-operative morbidity and mortality rates among patients undergoing bowel surgery with or without negative pressure wound therapy.
Time frame: Up to one year
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 6 Jan 2020.
- Individual participant dataSharing planned: No. Pooled data will be shared.
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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.
Carisa Cooney, MPH, CCRP principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Infection and Wound; Abdomen, Abdominal Wall, run by Johns Hopkins University at 1 site in United States.
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 2 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 6 Jan 2020. 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 United States. 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.
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 (per the 1999 Guideline for Prevention of Surgical Site Infection from the Hospital Infections Program at the National Center for Infectious Diseases, Centers for Disease Control and Prevention). (time frame: Up to one year). 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 6 Jan 2020.