Major Puerperal Infection, PostpartumNCT01637870
Negative Pressure Wound Therapy After Cesarean Delivery
A study testing Prevena negative pressure wound system in people with Major Puerperal Infection, Postpartum and Wound Complications, run by Abbey Hardy-Fairbanks at 1 site in United States.
Trial summary
This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Major Puerperal Infection, Postpartum, Wound Complications, Wound Seroma
- What is being tested?
- Prevena negative pressure wound system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old or older
- Having a cesarean delivery
- Has one or more of the following conditions:
- BMI > 30
- Anemia
- Preeclampsia (sever or mild)
Show all 13Show fewer
- Hemolysis, elevated liver enzymes and low platelets (HELLP)
- Urgent procedure
- Rupture of membranes prior to surgery for > 4 hours
- Chorioamnionitis
- Hypertension
- Diabetes (Gestational or pre-gestational)
- Dense adhesive disease
Who cannot join
- Age < 18 years old
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications
This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups.
It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.
Read the detailed description
Infectious complications have been found to be five times higher in women undergoing a cesarean delivery compared to a vaginal delivery. Known risk factors for wound complications are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders, emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss and preeclampsia.
This study is aimed at determining whether or not the use of a suction device placed on the wound instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The investigators will compare the results from the participants of this study to an existing data set of historical controls who underwent cesarean delivery. The study involves placing a single use, portable negative wound pressure system kept in place while in the hospital after surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound complications. The investigators will then compare the rates of wound infection and wound complications between these two groups.
- Conditions
- Major Puerperal Infection, Postpartum, Wound Complications, Wound Seroma, Caesarean Section Wound Separation, Wound Infection
- Being tested
- Prevena negative pressure wound system
- Keywords
- Cesarean delivery, Postpartum infection, Wound complications, Wound seroma, Wound separation, Wound infection, Negative pressure
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena negative pressure wound systemDevice
Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure pump | Experimental | Will have the Prevena negative pressure wound system placed at the time of surgery. Receives: Device: Prevena negative pressure wound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Complication Rate
Wound infection, separation or deep infection
Measured: Up to 6 weeks from time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Puerperal Infection, PostpartumStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbey Hardy-Fairbanks
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Sponsor-investigator, Abbey Hardy-Fairbanks, University of Iowa
- Investigators
- Sara Tikkanen, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637870
- Sponsor's protocol ID
- 201109727
- Status last verified
- Mar 2018
- First submitted
- 6 Jul 2012
- Last updated
- 18 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications
- ClinicalTrials.gov ID
- NCT01637870
- Acronym / sponsor ID
- 201109727
- Conditions
- Major Puerperal Infection, Postpartum, Wound Complications, Wound Seroma, Caesarean Section Wound Separation, Wound Infection
- Keywords
- Cesarean delivery, Postpartum infection, Wound complications, Wound seroma, Wound separation, Wound infection, Negative pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Abbey Hardy-FairbanksUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Posted 18 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups.
It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.
Detailed description
Infectious complications have been found to be five times higher in women undergoing a cesarean delivery compared to a vaginal delivery. Known risk factors for wound complications are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders, emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss and preeclampsia.
This study is aimed at determining whether or not the use of a suction device placed on the wound instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The investigators will compare the results from the participants of this study to an existing data set of historical controls who underwent cesarean delivery. The study involves placing a single use, portable negative wound pressure system kept in place while in the hospital after surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound complications. The investigators will then compare the rates of wound infection and wound complications between these two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Negative pressure pump | Experimental | Device: Prevena negative pressure wound systemWill have the Prevena negative pressure wound system placed at the time of surgery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 18 years old or older
- Having a cesarean delivery
- Has one or more of the following conditions:
- BMI > 30
- Anemia
Key exclusion criteria (2 listed)
- Age < 18 years old
- Unable to give informed consent
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 |
|---|---|---|
| Prevena negative pressure wound systemPlacement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication | Device | Negative pressure pump |
Primary outcome
Wound Complication Rate
Time frame: Up to 6 weeks from time of surgery
Wound infection, separation or deep infection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Major Puerperal Infection, Postpartum
Active, not recruiting
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
Preeclampsia, Hypertensive Disorder of Pregnancy
Not yet recruiting
Low-Sodium Diet for Postpartum Blood Pressure Control
Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Severe
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
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.
Sara Tikkanen, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena negative pressure wound system in people with Major Puerperal Infection, Postpartum and Wound Complications, run by Abbey Hardy-Fairbanks 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 13 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 18 Apr 2018. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Complication Rate (time frame: Up to 6 weeks from time of surgery). 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 18 Apr 2018.