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NCT04582045

Effect of Prophylactic Negative Pressure Versus Silver Impregnated Silicone Bandage on C-Section Infection Rates

Completed Results posted Last updated 19 January 2023
What this trial tests

trial testing silver impregnated dressing in D001458 in 1,064 participants. Completed in 15 June 2021.

Timeline
1 March 2019
Primary endpoint
1 March 2021
15 June 2021

Quick facts

Lead sponsorHealthPartners Institute
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,064
Start date1 March 2019
Primary completion1 March 2021
Estimated completion15 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

HealthPartners Institute

Who can join

Adults 18 to 55, female only, with D001458 or D011247. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Infection Rate Primary · 30 days from surgery

rate of post operative infection

GroupValue95% CI
Low Risk, Silver Impregnated17
Low Risk, Border Bandage18
High-risk, Silver Impregnated5
High-risk, Wound Vacuum5

Adverse events — posted to ClinicalTrials.gov

Time frame: 180-days post delivery (6-months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low Risk, Silver Impregnated
Serious: 24/446 (5%)
Deaths: 0/446
Low Risk, Border Bandage
Serious: 13/440 (3%)
Deaths: 0/440
High-risk, Silver Impregnated
Serious: 5/95 (5%)
Deaths: 0/95
High-risk, Wound Vacuum
Serious: 1/83 (1%)
Deaths: 0/83

Serious adverse events (1 terms)

ReactionSystemLow Risk, Silver ImpregnatedLow Risk, Border BandageHigh-risk, Silver Impregna…High-risk, Wound Vacuum
POST-PARTUM HOSPITALIZATION (6-months)Reproductive system and breast disorders
Other adverse events (1 terms — click to expand)

ReactionSystemLow Risk, Silver ImpregnatedLow Risk, Border BandageHigh-risk, Silver Impregna…High-risk, Wound Vacuum
Superficial Wound InfectionsSkin and subcutaneous tissue disorders

Most-reported serious reactions: POST-PARTUM HOSPITALIZATION (6-months).

Data from ClinicalTrials.gov NCT04582045 adverse events section.

Sponsor's own description

Effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Role of Silver and Silver-Based Products in Wound Management: A Review of Advances and Current Landscape.
    Du Y, Lu J, Guo X, Xia Z, et al · · 2026 · PMID 41590795 · DOI 10.3390/jfb17010027

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Other HealthPartners Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04582045.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing