Cesarean Section; Complications, Wound, Dehiscence
Conditions
Keywords
pregnancy, delivery, cesarean section, wound healing, silver-containing dressing
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.
Interventions
DEVICESilver-impregnated antimicrobial dressing
All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days.
Sponsors
Molnlycke Health Care AB
Loyola University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Consent to undergo cesarean delivery * Between the ages of 18 and 45 * Primary C-section * Subcuticular skin closure * Able to consent, fill out study documents, and complete all study procedures and follow-up visits
Exclusion criteria
* Patients with an allergy to silver * Inability to obtain informed consent * Staples * Repeat C-section * Vertical skin incision * Intrapartum fever of 100F or \>
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Disruption and/or Infection | 6 weeks postoperative | Rate of wound disruption and /or infection occurring by 6 weeks was compared to a historical control rate of 10%, and to a contemporary group who received a standard dressing |
Countries
United States
Participant flow
Recruitment details
Recruitment of all women admitted to labor and delivery or antepartum service to receive the silver-impregnated dressing should they deliver by primary csection
Participants by arm
| Arm | Count |
|---|---|
| Silver-impregnated Antimicrobial Dressing All participants undergoing primary cesarean section will receive a silver impregnated antimicrobial wound dressing (Mepilex Border AG), postoperative.
Silver-impregnated antimicrobial dressing: All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days. | 185 |
| Standard Dressing Those who had a primary csection with transverse incision and subcuticular closure but who had declined to receive the silver dressing.
Standard dressing: Telfa antimicrobial non-adherent island dressing covered with 10 sterile 4X4 gauge sponges secured wityh Tegaderm film tape. Dressing removed postop day 1 per routine. | 190 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | additional dressing | 1 | 0 |
| Overall Study | chorioamnionitis | 2 | 0 |
| Overall Study | never got dressing placed | 1 | 0 |
| Overall Study | vertical skin incision | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Dressing | Total | Silver-impregnated Antimicrobial Dressing |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 190 Participants | 375 Participants | 185 Participants |
| Age, Continuous | 29.21 years STANDARD_DEVIATION 6.23 | 29.83 years STANDARD_DEVIATION 6.31 | 30.47 years STANDARD_DEVIATION 6.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 97 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 31 Participants | 15 Participants |
| Race (NIH/OMB) White | 112 Participants | 237 Participants | 125 Participants |
| Region of Enrollment United States | 190 participants | 375 participants | 185 participants |
| Sex: Female, Male Female | 190 Participants | 375 Participants | 185 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 190 |
| other Total, other adverse events | 3 / 185 | 0 / 190 |
| serious Total, serious adverse events | 0 / 185 | 0 / 190 |
Outcome results
Primary
Number of Participants With Wound Disruption and/or Infection
Rate of wound disruption and /or infection occurring by 6 weeks was compared to a historical control rate of 10%, and to a contemporary group who received a standard dressing
Time frame: 6 weeks postoperative
Population: 185 of original 190 who received silver dressing included in analysis. Five excluded (2 with chorioamnionitis, 1 vertical incision, 1 additional dressing applied, 1 never received silver dressing)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Silver Dressing Group | Number of Participants With Wound Disruption and/or Infection | 5 Participants |
| Standard Dressing Group | Number of Participants With Wound Disruption and/or Infection | 9 Participants |