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Interim analysis showed no statistical significance achieved.
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A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver-containing surgical dressing | Active Comparator | Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver |
|
| Cloth adhesive dressing | Active Comparator | Soft cloth adhesive wound dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver-containing surgical dressing | Device | Dressing placed over surgical incision and remain for 3-5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Silver Treatment Efficacy | As measured by number of patients with postop infections at 6 wks | 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate Adjusted for Maternal BMI | 6 weeks postpartum | |
| Patient Dressing Cost | Total cost of dressings per group based on 1 dressing per patient | Postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly A. Bennett, MD | Vanderbilt University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Hospital | Nashville | Tennessee | 37232 | United States |
31 patients were removed from the study after consent but prior to study start, these participants did not meet inclusion / exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Silver-containing Surgical Dressing | Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days |
| FG001 | Cloth Adhesive Dressing | Soft cloth adhesive wound dressing Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Age ranged from 16-45 but was not analyzed by treatment arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Silver-containing Surgical Dressing | Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days |
| BG001 | Cloth Adhesive Dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age not recorded in several patients from both groups. |
| 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 | Silver Treatment Efficacy | As measured by number of patients with postop infections at 6 wks | Posted | Number | participants | 6 weeks postpartum |
|
2 years
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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 | Silver-containing Surgical Dressing | Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days No adverse events |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission to hospital for Infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelly Bennett; Director of Maternal Fetal Medicine | Vanderbilt University Medical Ctr., Dept OB/GYN | 6153436275 | kelly.a.bennett@vanderbilt.edu |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Cloth adhesive dressing | Device | Cloth adhesive dressing placed over surgical incision and remains for 3-5 days |
|
|
Soft cloth adhesive wound dressing Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days |
| BG002 | Total | Total of all reporting groups |
| Number |
| years |
|
| Sex/Gender, Customized | Women Only | Number | participants |
|
| Race/Ethnicity, Customized | Race/Ethnicity was not captured on every patient. | Number | participants |
|
| Average BMI | Mean | Full Range | kg/m^2 |
|
| Tobacco use during pregnancy | Number | participants |
|
| No use of alcohol during pregnancy | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Infection Rate Adjusted for Maternal BMI | Posted | Number | 95% Confidence Interval | percentage of participants | 6 weeks postpartum |
|
|
|
|
| Secondary | Patient Dressing Cost | Total cost of dressings per group based on 1 dressing per patient | Posted | Number | dollars | Postoperative |
|
|
|
| 3 |
| 239 |
| 25 |
| 239 |
| EG001 | Cloth Adhesive Dressing | Soft cloth adhesive wound dressing Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days No adverse events | 3 | 236 | 19 | 236 |
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