Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 3:17 PM
Study NCT ID:
NCT03136159
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications
Sponsor:
Loyola University
Organization:
Study Overview
Official Title:
The Role of Adherent Occlusive Antimicrobial Absorbent Foam Dressing in Prevention of Cesarean Section Wound Complications
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-cesarean section wound infections are responsible for longer hospital stays, readmissions, and ultimately, increased costs to the healthcare system. Silver-containing dressings may prevent wound infections. The purpose of the current study is to determine if the use of a silver-impregnated dressing decreases the occurence of wound infection following cesarean delivery.
Detailed Description:
A single-centered, single-arm clinical trial was originally designed to investigate the effects of an adherent soft silicone anti-microbial occlusive foam silver-impregnated dressing in preventing surgical site infection (SSI) in women delivered by primary cesarean section (CS). We sought to determine if the incidence of SSIs, would be lower in patients who received a silver-impregnated dressing as compared to those who received a standard dressing, when used as part of the overall hospital protocol for reducing SSIs. Given the addition of adjunctive azithromycin antibiotic prophylaxis for those who labored or had rupture of membranes prior to undergoing a non-elective CS right at the time of initiation of the study to our institution perioperative bundle, we also elected to undertake further analyses of observational data on those with the same study inclusion criteria receiving standard dressing undergoing primary CS with subcuticular skin closure during the same time period, rather than limiting comparisons of our outcomes solely to our historical SSI rates. In order to have this comparison group, patients who declined participation in the experimental groups were selected as our non-randomized control group, given fiscal restraints precluded conducting a randomized clinical trial (RCT). Demographic, labor, delivery, intraoperative and postoperative characteristic data were collected in a de-identified fashion. Medical record review and data entry were conducted by trained research personnel. All study procedures were approved by the Investigational Review Board.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: