Cesarean SectionNCT00696462
The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
A study testing forced-air warming in people with Cesarean Section, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- forced-air warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Apr 2009
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years old) female subjects who will undergo cesarean delivery regardless of indication.
- Subjects who have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Patients scheduled to receive prophylactic antibiotic therapy.
Who cannot join
- Patients who are undergoing a true emergent cesarean section that does not allow placement of the warming devices.
- Patients undergoing general anesthesia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
The purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.
Read the detailed description
Given the physiologic and experimental evidence regarding temperature regulation; it remains convincing that forced air warming is protective against the development of SSI. We will set out to prospectively study the effect of forced air warming on patients undergoing cesarean section.
- Conditions
- Cesarean Section
- Being tested
- forced-air warming
- Keywords
- forced-air warming, Bair Hugger, cesarean section, postoperative infection, surgical site infections
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
forced-air warmingDevice
Also called Bair Hugger device
forced-air warming device
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities |
| B | Active comparator | Patients in Group B will have a forced-air warming device applied to the upper body above the waist at the 43 degree Celsius setting. Receives: Device: forced-air warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment effects on wound infection
Measured: As is current standard of care post procedure
Secondary outcomes (1)
treatment effects on endometritis
Measured: as is current standard of care post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Study terminated for lack of funds to initiate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Curtis Baysinger, Vanderbilt University
- Investigators
- Curtis L Baysinger, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696462
- Sponsor's protocol ID
- 70346
- Status last verified
- Sep 2012
- First submitted
- 2 Jun 2008
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Forced Air Warming During Cesarean Section on Postoperative Infectious Morbidity
- ClinicalTrials.gov ID
- NCT00696462
- Acronym / sponsor ID
- 70346
- Conditions
- Cesarean Section
- Keywords
- forced-air warming, Bair Hugger, cesarean section, postoperative infection, surgical site infections
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated for lack of funds to initiate study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 12 Jun 2008 (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 purpose of this study will be to assess whether forced air warming decreases the rate of surgical site infections following cesarean section.
Detailed description
Given the physiologic and experimental evidence regarding temperature regulation; it remains convincing that forced air warming is protective against the development of SSI. We will set out to prospectively study the effect of forced air warming on patients undergoing cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Patients in Group A will undergo passive warming with a warmed cotton blanket placed over their upper extremities |
| B | Active comparator | Device: forced-air warmingPatients in Group B will have a forced-air warming device applied to the upper body above the waist at the 43 degree Celsius setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (≥ 18 years old) female subjects who will undergo cesarean delivery regardless of indication.
- Subjects who have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Patients scheduled to receive prophylactic antibiotic therapy.
Key exclusion criteria (2 listed)
- Patients who are undergoing a true emergent cesarean section that does not allow placement of the warming devices.
- Patients undergoing general anesthesia.
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 |
|---|---|---|
| forced-air warmingAlso: Bair Hugger deviceforced-air warming device | Device | B |
Primary outcome
treatment effects on wound infection
Time frame: As is current standard of care post procedure
1 secondary outcome
treatment effects on endometritis
Time frame: as is current standard of care post procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
- Vanderbilt University Medical Center Department of AnesthesiologyLink provided by the sponsor.
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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.
Curtis L Baysinger, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing forced-air warming in people with Cesarean Section, run by Vanderbilt 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 3 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: withdrawn, as of the sponsor's last update on 13 Sep 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
treatment effects on wound infection (time frame: As is current standard of care post procedure). 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 13 Sep 2012.