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| Name | Class |
|---|---|
| Cura Surgical | UNKNOWN |
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Obese patients undergoing cesarean section are at high risk for wound complications, which occur in approximately 20% of patients. This is a randomized controlled trial designed to determine whether the risk for wound-related complications can be reduced by covering the incision with a silver-impregnated dressing in the postoperative period.
This study's purpose was to evaluate the effect of a FDA approved silver-impregnated dressing on cesarean wound complications in obese women. It was initiated and 37 women were randomized, but because of logistical barriers, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. While a small number of photographs were taken as intended, they were lost due to a technological failure prior to any analysis. Therefore no outcome data could be analyzed. Nonetheless, as patients of the University of Michigan Health System, all research subjects received health care treatment appropriate to their medical condition and circumstances.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dressing | Placebo Comparator | Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing |
|
| Silverlon | Experimental | Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silverlon | Device | Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse. All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Experience One or More Wound Complications | A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Febrile Morbidity | Febrile morbidity would be measured by number of participants who experienced fever as a sign of infection at 2 days, and overall within 6 weeks of delivery. | 2 days, 6 weeks |
| Patient Report of Pain Severity and Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Chames, MD | University of Michigan | Principal Investigator |
| Angela Liang, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Von Voigtlander Womens' Hospital | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21730792 | Background | Krieger BR, Davis DM, Sanchez JE, Mateka JJ, Nfonsam VN, Frattini JC, Marcet JE. The use of silver nylon in preventing surgical site infections following colon and rectal surgery. Dis Colon Rectum. 2011 Aug;54(8):1014-9. doi: 10.1097/DCR.0b013e31821c495d. | |
| 17961738 | Background | Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485. doi: 10.1016/j.surneu.2007.05.045. |
| Label | URL |
|---|---|
| Cura Surgical | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dressing | Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse. |
| FG001 | Silverlon | Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse. All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dressing | Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse. |
| 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 Patients Who Experience One or More Wound Complications | A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report. | For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed. | Posted | 6 weeks |
|
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The original intent was to pull adverse event data from the medical record in batches as the study progressed. Because enrollment ceased early with insufficient numbers to draw conclusions, no adverse event data was collected in study. Therefore the 0 numbers affected listed below in serious and other adverse events represent no collected data of adverse events, not a guarantee that no adverse events happened. All participants were under medical care with attending physicians at all times.
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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 | Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Chames | University of Michigan | 734 764-1406 | mchames@med.umich.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Standard Dressing | Device | Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse. |
|
Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain
| 6 weeks |
| 18927482 | Background | Huckfeldt R, Redmond C, Mikkelson D, Finley PJ, Lowe C, Robertson J. A clinical trial to investigate the effect of silver nylon dressings on mediastinitis rates in postoperative cardiac sternotomy incisions. Ostomy Wound Manage. 2008 Oct;54(10):36-41. |
| BG001 |
| Silverlon |
Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse. All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Silverlon | Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse. All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum. |
|
| Secondary | Febrile Morbidity | Febrile morbidity would be measured by number of participants who experienced fever as a sign of infection at 2 days, and overall within 6 weeks of delivery. | For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed. | Posted | 2 days, 6 weeks |
|
|
| Secondary | Patient Report of Pain Severity and Control | Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain | For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed. | Posted | 6 weeks |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Silverlon | Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse. All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum. | 0 | 19 | 0 | 19 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |