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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD086007-01A1 | U.S. NIH Grant/Contract | View source |
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DSMB recommendation following interim analysis
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| 3M | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic NPWT | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days postoperatively |
| Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) |
| Measure | Description | Time Frame |
|---|---|---|
| Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus | Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus. | 30 days postoperatively |
| Incremental Cost Per SSI Prevented |
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Methodius G Tuuli, MD, MPH | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Medical Center | Birmingham | Alabama | 35233 | United States | ||
| Eskenazi Hopsital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24056202 | Background | 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. | |
| 26126306 | Background | Swift 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prophylactic NPWT | 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. Prophylactic NPWT: 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. |
| FG001 | Standard Dressing | 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. Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prophylactic NPWT | 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. Prophylactic NPWT: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 30 days postoperatively |
|
30 days
Occurring within data collection period, to be reported within 24 hours of learning of the event:
Serious Adverse Events - Death or Life-threatening situations:
Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission
Abnormal findings in labs or assessments will not be reported as adverse events.
Adverse Events of special interest will be reported - mild/moderate reactions:
Skin blisters Wound bleeding Allergic skin reaction
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prophylactic NPWT | 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. Prophylactic NPWT: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal ICU admission | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blisters | Skin and subcutaneous tissue disorders | Systematic Assessment |
The trial was stopped following a planned interim analysis, raising the possibility that it may be underpowered.
The clinical team could not be blinded to the intervention, raising the possibility of bias.
No adjustment was made for multiple comparisons, thus secondary end points could have occurred by chance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Graham Hogg | Indiana University School of Medicine | 317-962-0415 | gahogg@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2019 | Jan 14, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2019 | Jan 14, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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|
|
| Standard Dressing | Device | Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape. |
|
As defined according to the CDC's National Healthcare Safety Network criteria. |
| 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). | 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). | 30 days postoperatively |
| Patient Pain Score | On a scale of 0 (least) - 10 (most). | At discharge, an average of 4 days postoperatively |
| Patient Pain Score | On a scale of 0 (least) - 10 (most). | At postoperative day 30 |
| Patient Satisfaction Score | On a scale of 0 (least) - 10 (most). | At discharge, an average of 4 days postoperatively |
| Patient Satisfaction Score | On a scale of 0 (least) - 10 (most). | 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). | 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). | 30 days postoperatively |
Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.
| 30 days postoperatively |
| Incremental Cost Per Quality-Adjusted Life-year | Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data. | 30 days postoperatively |
| Risk Factors for Surgical Site Infections in Obese Women | Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data. | 30 days postoperatively |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | 70115 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63108 | United States |
| Mercy Hosptial St Louis | St Louis | Missouri | 63141 | United States |
| Background | Bullough, 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 |
| 27429285 | Background | 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. |
| 32960242 | Derived | Tuuli 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. |
| BG001 | Standard Dressing | 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. Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | body mass index (kg/m^2) | Mean | Standard Deviation | kg / m^2 |
|
| OG001 | Standard Dressing | 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. Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days postoperatively |
|
|
|
| Secondary | Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | As defined according to the CDC's National Healthcare Safety Network criteria. | Posted | Count of Participants | Participants | 30 days postoperatively |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 30 days postoperatively |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 30 days postoperatively |
|
|
|
| Secondary | Patient Pain Score | On a scale of 0 (least) - 10 (most). | Posted | Median | Inter-Quartile Range | score on a scale | At discharge, an average of 4 days postoperatively |
|
|
|
| Secondary | Patient Pain Score | On a scale of 0 (least) - 10 (most). | Posted | Median | Inter-Quartile Range | score on a scale | At postoperative day 30 |
|
|
|
| Secondary | Patient Satisfaction Score | On a scale of 0 (least) - 10 (most). | Posted | Median | Inter-Quartile Range | score on a scale | At discharge, an average of 4 days postoperatively |
|
|
|
| Secondary | Patient Satisfaction Score | On a scale of 0 (least) - 10 (most). | Posted | Median | Inter-Quartile Range | score on a scale | At postoperative day 30 |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 30 days postoperatively |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 30 days postoperatively |
|
|
|
| Other Pre-specified | Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus | Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus. | Not Posted | 30 days postoperatively | Participants |
| Other Pre-specified | Incremental Cost Per SSI Prevented | Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data. | Not Posted | 30 days postoperatively | Participants |
| Other Pre-specified | Incremental Cost Per Quality-Adjusted Life-year | Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data. | Not Posted | 30 days postoperatively | Participants |
| Other Pre-specified | Risk Factors for Surgical Site Infections in Obese Women | Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data. | Not Posted | 30 days postoperatively | Participants |
| 0 |
| 806 |
| 4 |
| 806 |
| 56 |
| 806 |
| EG001 | Standard Dressing | 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. Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape. | 0 | 802 | 5 | 802 | 5 | 802 |
| Maternal Sepsis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Postpartum hysterectomy | Reproductive system and breast disorders | Systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |