Surgical Wound InfectionsNCT00953784
Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
A study testing standard operating management in people with Surgical Wound Infections and Colorectal Surgery, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infections, Colorectal Surgery
- What is being tested?
- standard operating management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2010
- Phase
- Interventional
- 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
- Scheduled VA adult elective colorectal surgery patient
Who cannot join
- Non VA adults, emergent colorectal surgery, scheduled multiple surgery procedures,pts with other infections being treated
Trial locations and contacts
1 site in 1 country.
United States1 site
VA North Texas Health Care System
Dallas, Texas, 75216
About this study
This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.
Read the detailed description
A comparison between standard operating room:
- use of pre-op bowel prep (Golytely or Phosphosoda,plus 3 doses of oral antibiotics(Erythromycin and Neomycin), and fleets enema the day before surgery
- Standard anesthesia FiO2 (approx. 30-50%)during surgery
- Standard IV fluids during surgery(greater than 200cc per hour)
- Standard post-op O2 by mask for 2 hours
To extended operating room procedures of:
- No po antibiotics or pre-op bowel prep other than enema prior to surgery
- Skin warming at least 15 minutes prior to and during surgery(core temp 36C+)
- IOBAN drapes and Plastic wound protectors used during surgery
- Restricted IV fluids less than 200cc per hour during surgery
- Increased FiO2 to 80% during surgery and 2 hours after by mask
Monitoring for post-op wound infections at discharge and up to 30days post-op
- Conditions
- Surgical Wound Infections, Colorectal Surgery
- Being tested
- standard operating management
- Keywords
- surgery, wound infections, colorectal
- Medical subject headings
- Surgical Wound Infection, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard operating managementProcedure or surgery
Also called Extended management
As previously described
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard management |
| 2 | Active comparator | Extended management: with no bowel prep except enema,restricted fluids, increased O2,body warming and use of skin protectors during surgery as previously described Receives: Procedure: standard operating management |
What is being measured
The primary outcome is the main question the study is designed to answer.
%/type Surgical wound infections rated per infection classifications of NNIS/CDC
Measured: with in 30 days post-op
Secondary outcomes (1)
%/type surgical wound infections per classifications per NNIS/CDC
Measured: at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startApr 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- James LePage, Ph.D, Study chair, ACOS for Research VANorth Tx Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953784
- Sponsor's protocol ID
- 07-025
- Status last verified
- May 2010
- First submitted
- 5 Aug 2009
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.
PubMed 21079110
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00953784
- Acronym / sponsor ID
- 07-025
- Conditions
- Surgical Wound Infections, Colorectal Surgery
- Keywords
- surgery, wound infections, colorectal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- Apr 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 6 Aug 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.
This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.
Detailed description
A comparison between standard operating room:
- use of pre-op bowel prep (Golytely or Phosphosoda,plus 3 doses of oral antibiotics(Erythromycin and Neomycin), and fleets enema the day before surgery
- Standard anesthesia FiO2 (approx. 30-50%)during surgery
- Standard IV fluids during surgery(greater than 200cc per hour)
- Standard post-op O2 by mask for 2 hours
To extended operating room procedures of:
- No po antibiotics or pre-op bowel prep other than enema prior to surgery
- Skin warming at least 15 minutes prior to and during surgery(core temp 36C+)
- IOBAN drapes and Plastic wound protectors used during surgery
- Restricted IV fluids less than 200cc per hour during surgery
- Increased FiO2 to 80% during surgery and 2 hours after by mask
Monitoring for post-op wound infections at discharge and up to 30days post-op
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard management |
| 2 | Active comparator | Procedure: standard operating managementExtended management: with no bowel prep except enema,restricted fluids, increased O2,body warming and use of skin protectors during surgery as previously described |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled VA adult elective colorectal surgery patient
Key exclusion criteria (1 listed)
- Non VA adults, emergent colorectal surgery, scheduled multiple surgery procedures,pts with other infections being treated
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 |
|---|---|---|
| standard operating managementAlso: Extended managementAs previously described | Procedure or surgery | 2 |
Primary outcome
%/type Surgical wound infections rated per infection classifications of NNIS/CDC
Time frame: with in 30 days post-op
1 secondary outcome
%/type surgical wound infections per classifications per NNIS/CDC
Time frame: at hospital discharge
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 30 Jun 2010.
- Derived from this study: PubMed 21079110Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.
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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.
James LePage, Ph.D study chair
ACOS for Research VANorth Tx Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard operating management in people with Surgical Wound Infections and Colorectal Surgery, run by Dallas VA Medical Center 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 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 30 Jun 2010. 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?
%/type Surgical wound infections rated per infection classifications of NNIS/CDC (time frame: with in 30 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953784, which also lists 1 linked publication.
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 30 Jun 2010.