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The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.
Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of > 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients.
This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Wound Closure | Active Comparator | Standard surgical closure of the fascia and skin. |
|
| Negative Pressure Wound Therapy | Experimental | Standard surgical closure as used by the standard of care group plus placement of the Prevenaâ„¢ Incision Management System over the closed incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Wound Closure | Procedure | The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if >2 cm deep, followed by staple or suture closure of the skin. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection) | one month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies | up to 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deanna G. Teoh, M.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
93 participants originally consented, one withdrew consent and 11 did not return updated HIPAA forms and therefore could not be included in the analysis
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Wound Closure | Standard surgical closure of the fascia and skin. |
| FG001 | Negative Pressure Wound Therapy | Standard surgical closure as used by the standard of care group plus placement of the Prevenaâ„¢ Incision Management System over the closed incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Wound Closure | Standard surgical closure of the fascia and skin. |
| BG001 | Negative Pressure Wound Therapy | Standard surgical closure as used by the standard of care group plus placement of the Prevenaâ„¢ Incision Management System over the closed incision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Who Experience Wound Complications (Wound Dehiscence or Infection) | Follow up data is not available for 2 participants | Posted | Count of Participants | Participants | one month after surgery |
|
Upto 12 weeks after surgery
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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 Wound Closure | Standard surgical closure of the fascia and skin. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postop ileus | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital-acquired pneumonia | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deanna GK Teoh | Masonic Cancer Center, University of Minnesota | 612-626-3111 | dkteoh@umn.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 | Dec 9, 2013 | Jun 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D009765 | Obesity |
| D005833 | Genital Neoplasms, Female |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
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|
| Prevenaâ„¢ Incision Management System | Device | At the close of surgery, the Prevenaâ„¢ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital. |
|
| BG002 | Total | Total of all reporting groups |
| 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 | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies | Only those participants who received adjuvant therapies were analyzed in both arms. Rest of the patients didn't have cancer that required subsequent therapies. | Posted | Median | Full Range | days | up to 20 weeks |
|
|
|
| 38 |
| 7 |
| 38 |
| 5 |
| 38 |
| EG001 | Negative Pressure Wound Therapy | Standard surgical closure as used by the standard of care group plus placement of the Prevenaâ„¢ Incision Management System over the closed incision. | 0 | 43 | 17 | 43 | 3 | 43 |
| pulmonary embolism | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Anastomotic leak | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vaginal cuff dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| atrial fibrillation with rapid ventricular response | Cardiac disorders | Non-systematic Assessment |
|
| Postop hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Pelvic abscess | Infections and infestations | Non-systematic Assessment |
|
| malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Superficial wound infection, requiring readmission | Infections and infestations | Non-systematic Assessment |
|
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Bowel perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Postop hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Genital yeast infection | Infections and infestations | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Superficial wound infection | Infections and infestations | Non-systematic Assessment |
|
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| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |