Surgical Wound InfectionPrevena-CNCT03009110
Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial
A study testing Prophylactic NPWT and Standard Dressing in people with Surgical Wound Infection and Cesarean Section, run by Indiana University at 6 sites in United States.
Trial summary
The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Infection, Cesarean Section
- What is being tested?
- Prophylactic NPWT and Standard Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,624 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Feb 2017to 13 Nov 2019
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age ≥23weeks
- BMI≥30 Pre-pregnancy or BMI at first prenatal visit
- Planned or unplanned cesarean delivery
Who cannot join
- Non-availability for postoperative follow-up
- Contraindication to NPWT applicable to women undergoing cesarean: Pre-existing infection around incision site, Bleeding disorder, Therapeutic anticoagulation, Irradiated skin, Allergy to any component of the dressing (e.g. silver, acrylic, silicone, adhesive tape)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama Medical Center
Birmingham, Alabama, 35233
Eskenazi Hopsital
Indianapolis, Indiana, 46202
Methodist Hospital
Indianapolis, Indiana, 46202
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115
Barnes-Jewish Hospital
St Louis, Missouri, 63108
Mercy Hosptial St Louis
St Louis, Missouri, 63141
About this study
Official title: Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: a Multicenter Randomized Trial
The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (SSIs) in obese women.
Read the detailed description
Experimental evidence suggests that NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Obesity (body mass index [BMI] ≥30kg/m2) increases the risk for both cesarean delivery and SSIs compared to non-obese women. The increased risk of SSIs is in part due to the increased thickness of the subcutaneous space, allowing collection of exudates and increasing tension on wound edges, promoting the growth of bacteria, and leading to wound infection and breakdown. Thus, prophylactic NPWT may be particularly effective in this patient population.
During the 5-year project period, investigators from 4 collaborating perinatal centers in the United Stated (two university and two community) will randomize 2850 obese women undergoing cesarean delivery to receive either prophylactic negative pressure wound therapy with the Prevena device or standard wound dressing. Women will be followed up to 30 days postoperatively to ascertain study outcomes.
The primary outcome for the trial is superficial or deep SSI after cesarean according to the CDC's National Healthcare Safety Network definitions. The investigators will also assess other wound complications, adverse events potentially attributable to NPWT and cost-effectiveness as measured by incremental cost per case of SSI prevented and per quality-adjusted life year (QALY).
- Conditions
- Surgical Wound Infection, Cesarean Section
- Being tested
- Prophylactic NPWT, Standard Dressing
- 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.
Prophylactic NPWTDevice
Also called Prevena
The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.
Standard DressingDevice
Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic NPWT | Experimental | Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized. Receives: Device: Prophylactic NPWT |
| Standard Dressing | Active comparator | Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours. Receives: Device: Standard Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)
As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.
Measured: 30 days postoperatively
Secondary outcomes (10)
Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)
As defined according to the CDC's National Healthcare Safety Network criteria.
Measured: 30 days postoperatively
Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)
As defined according to the CDC's National Healthcare Safety Network criteria.
Measured: 30 days postoperatively
Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)
Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).
Measured: 30 days postoperatively
Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).
Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).
Measured: 30 days postoperatively
Patient Pain Score
On a scale of 0 (least) - 10 (most).
Measured: At discharge, an average of 4 days postoperatively
Patient Pain Score
On a scale of 0 (least) - 10 (most).
Measured: At postoperative day 30
Patient Satisfaction Score
On a scale of 0 (least) - 10 (most).
Measured: At discharge, an average of 4 days postoperatively
Patient Satisfaction Score
On a scale of 0 (least) - 10 (most).
Measured: At postoperative day 30
Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)
Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization).
Measured: 30 days postoperatively
Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)
Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Why it stopped: DSMB recommendation following interim analysis
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies 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
- None (open label)
- Enrolment
- 1,624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 3M
- Responsible party
- Principal investigator, David Haas, Indiana University
- Investigators
- Methodius G Tuuli, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009110
- Sponsor's protocol ID
- IRB ID #: 201603062
- Other IDs
- 1R01HD086007-01A1
- Acronym
- Prevena-C
- Status last verified
- May 2023
- First submitted
- 28 Dec 2016
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.
PubMed 24056202Swift SH, Zimmerman MB, Hardy-Fairbanks AJ. Effect of Single-Use Negative Pressure Wound Therapy on Postcesarean Infections and Wound Complications for High-Risk Patients. J Reprod Med. 2015 May-Jun;60(5-6):211-8.
PubMed 26126306Bullough, L, Wilkinson, D., Burns, S, Wan, L, Changing wound care protocols to reduce postoperative caesarean section infection and readmission, Wounds , 2014 (10), 1 : 72 - 76. 46
Chaboyer W, Anderson V, Webster J, Sneddon A, Thalib L, Gillespie BM. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT. Healthcare (Basel). 2014 Sep 30;2(4):417-28. doi: 10.3390/healthcare2040417.
PubMed 27429285Tuuli MG, Liu J, Tita ATN, Longo S, Trudell A, Carter EB, Shanks A, Woolfolk C, Caughey AB, Warren DK, Odibo AO, Colditz G, Macones GA, Harper L. Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2020 Sep 22;324(12):1180-1189. doi: 10.1001/jama.2020.13361.
PubMed 32960242
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean: a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT03009110
- Acronym / sponsor ID
- Prevena-C / IRB ID #: 201603062
- Conditions
- Surgical Wound Infection, Cesarean Section
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommendation following interim analysis
- Enrolment
- 1,624 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 3M
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (SSIs) in obese women.
Detailed description
Experimental evidence suggests that NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Obesity (body mass index [BMI] ≥30kg/m2) increases the risk for both cesarean delivery and SSIs compared to non-obese women. The increased risk of SSIs is in part due to the increased thickness of the subcutaneous space, allowing collection of exudates and increasing tension on wound edges, promoting the growth of bacteria, and leading to wound infection and breakdown. Thus, prophylactic NPWT may be particularly effective in this patient population.
During the 5-year project period, investigators from 4 collaborating perinatal centers in the United Stated (two university and two community) will randomize 2850 obese women undergoing cesarean delivery to receive either prophylactic negative pressure wound therapy with the Prevena device or standard wound dressing. Women will be followed up to 30 days postoperatively to ascertain study outcomes.
The primary outcome for the trial is superficial or deep SSI after cesarean according to the CDC's National Healthcare Safety Network definitions. The investigators will also assess other wound complications, adverse events potentially attributable to NPWT and cost-effectiveness as measured by incremental cost per case of SSI prevented and per quality-adjusted life year (QALY).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic NPWT | Experimental | Device: Prophylactic NPWTWomen assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized. |
| Standard Dressing | Active comparator | Device: Standard DressingWomen assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age ≥23weeks
- BMI≥30 Pre-pregnancy or BMI at first prenatal visit
- Planned or unplanned cesarean delivery
Key exclusion criteria (2 listed)
- Non-availability for postoperative follow-up
- Contraindication to NPWT applicable to women undergoing cesarean: Pre-existing infection around incision site, Bleeding disorder, Therapeutic anticoagulation, Irradiated skin, Allergy to any component of the dressing (e.g. silver, acrylic, silicone, adhesive tape)
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 |
|---|---|---|
| Prophylactic NPWTAlso: PrevenaThe Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure. | Device | Prophylactic NPWT |
| Standard DressingStandard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape. | Device | Standard Dressing |
Primary outcome
Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)
Time frame: 30 days postoperatively
As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.
10 secondary outcomes
Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)
Time frame: 30 days postoperatively
Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)
Time frame: 30 days postoperatively
Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)
Time frame: 30 days postoperatively
Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).
Time frame: 30 days postoperatively
Patient Pain Score
Time frame: At discharge, an average of 4 days postoperatively
Patient Pain Score
Time frame: At postoperative day 30
Patient Satisfaction Score
Time frame: At discharge, an average of 4 days postoperatively
Patient Satisfaction Score
Time frame: At postoperative day 30
Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)
Time frame: 30 days postoperatively
Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)
Time frame: 30 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24056202Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.
- Background: PubMed 26126306Swift SH, Zimmerman MB, Hardy-Fairbanks AJ. Effect of Single-Use Negative Pressure Wound Therapy on Postcesarean Infections and Wound Complications for High-Risk Patients. J Reprod Med. 2015 May-Jun;60(5-6):211-8.
- BackgroundBullough, L, Wilkinson, D., Burns, S, Wan, L, Changing wound care protocols to reduce postoperative caesarean section infection and readmission, Wounds , 2014 (10), 1 : 72 - 76. 46
- Background: PubMed 27429285Chaboyer W, Anderson V, Webster J, Sneddon A, Thalib L, Gillespie BM. Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT. Healthcare (Basel). 2014 Sep 30;2(4):417-28. doi: 10.3390/healthcare2040417.
- Derived from this study: PubMed 32960242Tuuli MG, Liu J, Tita ATN, Longo S, Trudell A, Carter EB, Shanks A, Woolfolk C, Caughey AB, Warren DK, Odibo AO, Colditz G, Macones GA, Harper L. Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2020 Sep 22;324(12):1180-1189. doi: 10.1001/jama.2020.13361.
- Individual participant dataSharing planned: No
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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.
Methodius G Tuuli, MD, MPH principal investigator
Indiana University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic NPWT and Standard Dressing in people with Surgical Wound Infection and Cesarean Section, run by Indiana University at 6 sites 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: stopped early, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 1 Jun 2023). 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?
Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) (time frame: 30 days postoperatively). 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 NCT03009110, which also lists 5 linked publications.
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 1 Jun 2023.