Bacterial TranslocationNCT01007487
Plastic Wound Retractors and Bacterial Translocation in Abdominal Surgery
An observational study of Bacterial Translocation and Surgical Site Infection, run by St Vincent's University Hospital, Ireland at 2 sites in Ireland.
Trial summary
Hypothesis: Plastic wound retractors reduce passage of bacteria from the abdomen to the surgical incision site in abdominal surgery Currently, plastic wound retractors are used in abdominal surgery to facilitate access to the abdominal cavity. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Bacterial Translocation, Surgical Site Infection, Abdominal Surgery
- How many people
- 250 participants
- Where
- 2 sitesIreland
- Study dates
- Jan 2008to Jul 2010
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing abdominal surgery in which a plastic wound retractor is used.
Who may be able to join
- Patients undergoing abdominal surgery in which a plastic wound retractor is used
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Mater Misericordiae University Hospital, Eccles Street
Dublin, Dublin 1
St. Vincent's University Hospital, Elm Park
Dublin
About this study
Official title: Wound Retractor or Protector? Efficacy of a Plastic Wound Retractor (Alexis®) in Impeding Translocation of Enteric Bacteria to the Surgical Incision Site in Abdominal Surgery.
Hypothesis: Plastic wound retractors reduce passage of bacteria from the abdomen to the surgical incision site in abdominal surgery
Currently, plastic wound retractors are used in abdominal surgery to facilitate access to the abdominal cavity. This study aims to establish whether they also prevent bacteria crossing from the abdominal cavity to the surgical incision site. Patients undergoing abdominal surgery in which a plastic wound retractor (Alexis®)is used are eligible for inclusion in the study. Swabs are taken from the inside and the outside of the plastic wound retractor prior to removing the retractor from the abdomen. The bacterial flora from swabs taken inside and outside the plastic wound protector are then compared to see if there is any difference between inside and outside the retractor. Bacteria are classified as 'enteric'(i.e. from the gastrointestinal tract) or 'skin' bacteria, depending on their usual location. The study aims to establish whether a plastic wound retractor (Alexis®) reduces translocation of enteric bacteria to the surgical incision site.
Read the detailed description
Plastic wound retractors are currently used in abdominal surgery for wound retraction. They allow access to intra-abdominal organs through an incision in abdominal surgery. Plastic wound retractors may also act as a barrier to bacterial translocation from the abdominal cavity to the wound. The purpose of this study was to compare microbial flora from inside and outside the plastic wound retractor to establish whether plastic wound retractors affect bacterial translocation.
METHODS This multi-centre prospective observational study is being conducted between November 2007 and January 2010. Patients undergoing elective or emergency abdominal surgery in which an Alexis® wound retractor is used are eligible for inclusion in the study. Swabs are taken from inside and outside the Alexis® wound protector immediately prior to removal of the wound protector from the abdominal cavity. Swabs undergo gram stain and culture. "Inside" the wound swab is defined as the part of the wound protector in contact with the intra-abdominal organs, "outside" is the part in contact with the skin and subcutaneous tissues. Results from inside and outside swabs are then compared to establish whether there is a difference in bacterial flora. The study aims to establish whether a plastic wound retractor (Alexis®) reduces translocation of enteric bacteria to the surgical incision site.
- Keywords
- Plastic wound protector, Plastic wound retractor, Bacterial translocation, Surgical site infection, Abdominal surgery, Wound infection
- Medical subject headings
- Surgical Wound Infection, Wound Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria.
Measured: 2 years
Secondary outcomes (1)
Comparison of bacteria isolated from intraoperative swabs and subsequent post-operative swabs (<30days post-operatively)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial TranslocationStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Investigators
- Desmond Winter, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007487
- Sponsor's protocol ID
- HMSVUH1
- Status last verified
- Nov 2009
- First submitted
- 3 Nov 2009
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Retractor or Protector? Efficacy of a Plastic Wound Retractor (Alexis®) in Impeding Translocation of Enteric Bacteria to the Surgical Incision Site in Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT01007487
- Acronym / sponsor ID
- HMSVUH1
- Keywords
- Plastic wound protector, Plastic wound retractor, Bacterial translocation, Surgical site infection, Abdominal surgery, Wound infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Nov 2009 (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.
Hypothesis: Plastic wound retractors reduce passage of bacteria from the abdomen to the surgical incision site in abdominal surgery
Currently, plastic wound retractors are used in abdominal surgery to facilitate access to the abdominal cavity. This study aims to establish whether they also prevent bacteria crossing from the abdominal cavity to the surgical incision site. Patients undergoing abdominal surgery in which a plastic wound retractor (Alexis®)is used are eligible for inclusion in the study. Swabs are taken from the inside and the outside of the plastic wound retractor prior to removing the retractor from the abdomen. The bacterial flora from swabs taken inside and outside the plastic wound protector are then compared to see if there is any difference between inside and outside the retractor. Bacteria are classified as 'enteric'(i.e. from the gastrointestinal tract) or 'skin' bacteria, depending on their usual location. The study aims to establish whether a plastic wound retractor (Alexis®) reduces translocation of enteric bacteria to the surgical incision site.
Detailed description
Plastic wound retractors are currently used in abdominal surgery for wound retraction. They allow access to intra-abdominal organs through an incision in abdominal surgery. Plastic wound retractors may also act as a barrier to bacterial translocation from the abdominal cavity to the wound. The purpose of this study was to compare microbial flora from inside and outside the plastic wound retractor to establish whether plastic wound retractors affect bacterial translocation.
METHODS This multi-centre prospective observational study is being conducted between November 2007 and January 2010. Patients undergoing elective or emergency abdominal surgery in which an Alexis® wound retractor is used are eligible for inclusion in the study. Swabs are taken from inside and outside the Alexis® wound protector immediately prior to removal of the wound protector from the abdominal cavity. Swabs undergo gram stain and culture. "Inside" the wound swab is defined as the part of the wound protector in contact with the intra-abdominal organs, "outside" is the part in contact with the skin and subcutaneous tissues. Results from inside and outside swabs are then compared to establish whether there is a difference in bacterial flora. The study aims to establish whether a plastic wound retractor (Alexis®) reduces translocation of enteric bacteria to the surgical incision site.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing abdominal surgery in which a plastic wound retractor is used.
Key inclusion criteria (1 listed)
- Patients undergoing abdominal surgery in which a plastic wound retractor is used
Key exclusion criteria (1 listed)
- N/A
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
Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria.
Time frame: 2 years
1 secondary outcome
Comparison of bacteria isolated from intraoperative swabs and subsequent post-operative swabs (<30days post-operatively)
Time frame: 3 years
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 20 Jul 2011.
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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.
Desmond Winter principal investigator
St Vincent's University Hospital, Ireland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Translocation and Surgical Site Infection, run by St Vincent's University Hospital, Ireland at 2 sites in Ireland.
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 1 inclusion and 1 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 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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?
Comparison of inside swabs positive for enteric bacteria and outside swabs positive for enteric bacteria. (time frame: 2 years). 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 20 Jul 2011.