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Poor enrollment. No apparent treatment effect.
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| Name | Class |
|---|---|
| CAMC Health System | OTHER |
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Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study.
Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative pressure wound closure | Experimental | Negative Pressure wound closure |
|
| Standard wound closure | Active Comparator | Standard Wound Closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative pressure wound closure | Procedure | Applying negative pressure to primary wound closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Patients Experiencing a Wound Complication | Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma. | 6 Weeks post-partum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Stitely, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAMC Women and Children's Hospital | Charleston | West Virginia | 25304 | United States | ||
| West Virginia University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Pressure Wound Closure | Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound. |
| FG001 | Standard Wound Closure | Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard wound closure | Procedure | Standard wound closure |
|
| Morgantown |
| West Virginia |
| 26506 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Pressure Wound Closure | Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound. |
| BG001 | Standard Wound Closure | Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Total Number of Patients Experiencing a Wound Complication | Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma. | Posted | Number | Participants | 6 Weeks post-partum |
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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 | Negative Pressure Wound Closure | Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound. | 0 | 28 | 15 | 28 | ||
| EG001 | Standard Wound Closure | Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples. | 0 | 26 | 10 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound complication | Skin and subcutaneous tissue disorders | Systematic Assessment | Any wound complication including superficial or deep surgical site infection, wound disruption, hematoma or seroma. |
|
Slow enrollment caused the closure of the trial prior to meeting enrollment target.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael L. Stitely, MD | West Viginia University | 304-293-1566 | mstitely@hsc.wvu.edu |
| ID | Term |
|---|---|
| D013529 | Surgical Wound Dehiscence |
| D014946 | Wound Infection |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| >=65 years |
|
| Male |
|