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| Name | Class |
|---|---|
| Irrimax Corporation | INDUSTRY |
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This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irrisept | Experimental | The experimental arm will receive irrigation solution Irrisept administered through a proprietary bottle (jet lavage) following the closure of the fascia in Cesarean section. |
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| Normal Saline | Active Comparator | The active comparator arm will receive the standard of care irrigation solution, normal saline, administered via standard pour over following the closure of the fascia in Cesarean section. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irrisept | Device | 450ml low concentration (0.05%) Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite wound evaluation scale after caesarean delivery | Wound Evaluation scale will be used to evaluate appropriate healing in the following categories: redness, bruising, discharge, tissue breakdown, wound infection | Up to 8 weeks postop |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikia Gray-Hutto, AS | Contact | 9095584000 | 44428 | nhutto@llu.edu |
| Ashra Denise Tugung, BS | Contact | 9096515580 | atugung@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ruofan Yao, MD, MPH | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Recruiting | Loma Linda | California | 92354 | United States |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline | Drug | 450mL |
|