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Effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate
Comparison of effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate as compared to wound vacuum in high risk women and traditional border dressing in low risk women in adult women having uncomplicated cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low risk, silver impregnated | low risk, silver impregnated |
| |
| low risk, border bandage | low risk, border bandage | ||
| high-risk, silver impregnated | high-risk, silver impregnated |
| |
| high-risk, wound vacuum | high-risk, wound vacuum |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silver impregnated dressing | Device | comparison of Mepilex versus our standard techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate | rate of post operative infection | 30 days from surgery |
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Inclusion Criteria:
Exclusion Criteria:
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pregnant women
adult women requiring cesarean section
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| Name | Affiliation | Role |
|---|---|---|
| Larry Goldenberg | Regions Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55403 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Risk, Silver Impregnated | low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques |
| FG001 | Low Risk, Border Bandage | low risk, border (traditional) bandage |
| FG002 | High-risk, Silver Impregnated | high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques |
| FG003 | High-risk, Wound Vacuum | high-risk, negative-pressure wound vacuum |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Risk, Silver Impregnated | low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques |
| BG001 | Low Risk, Border (Traditional) Bandage |
| 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 | Infection Rate | rate of post operative infection | Posted | Count of Participants | Participants | 30 days from surgery |
|
180-days post delivery (6-months)
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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 | Low Risk, Silver Impregnated | low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| POST-PARTUM HOSPITALIZATION (6-months) | Reproductive system and breast disorders | Systematic Assessment | INPATIENT HOSPITALIZATIONS (Post-partum) within 6-months of delivery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial Wound Infections | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda M. Loes | HealthPartners Institute | 952-967-7862 | linda.m.loes@healthpartners.com |
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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 | Jun 12, 2019 | Apr 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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|
low risk, border (traditional) bandage
standard border wound bandage
| BG002 | High-risk, Silver Impregnated | high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques |
| BG003 | High-risk, Negative-pressure Wound Vacuum | high-risk, negative-pressure wound vacuum Commercially available negative-pressure wound vacuum |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Enrollment Parameters | Count of Participants | Participants |
|
| OG003 | High-risk, Wound Vacuum | high-risk, negative-pressure wound vacuum |
|
|
| 0 |
| 446 |
| 24 |
| 446 |
| 6 |
| 446 |
| EG001 | Low Risk, Border Bandage | low risk, (traditional) border bandage | 0 | 440 | 13 | 440 | 3 | 440 |
| EG002 | High-risk, Silver Impregnated | high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques | 0 | 95 | 5 | 95 | 2 | 95 |
| EG003 | High-risk, Wound Vacuum | high-risk, negative-pressure wound vacuum | 0 | 83 | 1 | 83 | 3 | 83 |
|
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