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The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI > 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.
Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI > 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dressing | Active Comparator | Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery. |
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| Negative Pressure Wound Therapy Dressing | Experimental | Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Dressing | Device | Patients are randomized to the standard dressing at the time of fascial closure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment | Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. | 2 weeks post partum/post operative period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael House, MD | Tufts Medical Center, physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34058423 | Derived | Peterson AT, Bakaysa SL, Driscoll JM, Kalyanaraman R, House MD. Randomized controlled trial of single-use negative-pressure wound therapy dressings in morbidly obese patients undergoing cesarean delivery. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100410. doi: 10.1016/j.ajogmf.2021.100410. Epub 2021 May 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dressing | Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery. Standard Dressing: Patients are randomized to the standard dressing at the time of fascial closure. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 8, 2019 |
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| Negative Pressure Wound Therapy Dressing | Device | Patients are randomized to the NPWT at the time of fascial closure. |
|
| 2 weeks post partum/post operative period |
| Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment | Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation > 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management. | 2 weeks post partum/post operative period |
| Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively. | Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. | 6 weeks post partum/post operative period |
| Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. | 6 weeks post partum/post operative period |
| Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively | Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation > 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management. | 6 weeks post partum/post operative period |
| Negative Pressure Wound Therapy Dressing |
Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery. Negative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dressing | Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery. Standard Dressing: Patients are randomized to the standard dressing at the time of fascial closure. |
| BG001 | Negative Pressure Wound Therapy Dressing | Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery. Negative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| gestational age | Mean | Standard Deviation | weeks |
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| gestational diabetes | Count of Participants | Participants |
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| pregestational diabetes | Count of Participants | Participants |
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| current smoker | Count of Participants | Participants |
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| former smoker | Count of Participants | Participants |
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| chronic steroid use | Count of Participants | Participants |
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| Insulin use | Count of Participants | Participants |
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| Oral Hypoglycemic agent use | Count of Participants | Participants |
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| 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 Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment | Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. | Posted | Count of Participants | Participants | 2 weeks post partum/post operative period |
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| Secondary | Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment | The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. | Posted | Count of Participants | Participants | 2 weeks post partum/post operative period |
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| Secondary | Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment | Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation > 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management. | Posted | Count of Participants | Participants | 2 weeks post partum/post operative period |
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| Secondary | Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively. | Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. | Posted | Count of Participants | Participants | 6 weeks post partum/post operative period |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively | The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. | Posted | Count of Participants | Participants | 6 weeks post partum/post operative period |
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| Secondary | Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively | Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation > 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management. | Posted | Count of Participants | Participants | 6 weeks post partum/post operative period |
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6 weeks
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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 | Standard Dressing | Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery. Standard Dressing: Patients are randomized to the standard dressing at the time of fascial closure. | 0 | 55 | 0 | 55 | 0 | 55 |
| EG001 | Negative Pressure Wound Therapy Dressing | Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery. Negative Pressure Wound Therapy Dressing: Patients are randomized to the NPWT at the time of fascial closure. | 0 | 55 | 0 | 55 | 0 | 55 |
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Early termination secondary to slow recruitment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashley T. Peterson, MD, Study Coordinator | Tufts Medical Center | 617-636-5000 | 2382 | apeterson@tuftsmedicalcenter.org |
| Sep 3, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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