Wound Infection
Conditions
Keywords
Wound infection prevention, Silver-containing surgical dressing, Cesarean delivery infection prevention
Brief summary
A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.
Interventions
DEVICESilver-containing surgical dressing
Dressing placed over surgical incision and remain for 3-5 days
DEVICECloth adhesive dressing
Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Cesarean delivery with pfannenstiel incision
Exclusion criteria
* Incision other than pfannenstiel * Silver allergy * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Silver Treatment Efficacy | 6 weeks postpartum | As measured by number of patients with postop infections at 6 wks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection Rate Adjusted for Maternal BMI | 6 weeks postpartum | — |
| Patient Dressing Cost | Postoperative | Total cost of dressings per group based on 1 dressing per patient |
Countries
United States
Participant flow
Pre-assignment details
31 patients were removed from the study after consent but prior to study start, these participants did not meet inclusion / exclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| Silver-containing Surgical Dressing Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days | 239 |
| Cloth Adhesive Dressing Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days | 236 |
| Total | 475 |
Baseline characteristics
| Characteristic | Silver-containing Surgical Dressing | Cloth Adhesive Dressing | Total |
|---|---|---|---|
| Age, Customized 16-25 | 71 years | 88 years | 159 years |
| Age, Customized 26-35 | 143 years | 113 years | 256 years |
| Age, Customized 36-45 | 24 years | 30 years | 54 years |
| Average BMI | 32.0 kg/m^2 | 32.8 kg/m^2 | 32.4 kg/m^2 |
| No use of alcohol during pregnancy | 239 participants | 236 participants | 475 participants |
| Race/Ethnicity, Customized African American | 43 participants | 50 participants | 93 participants |
| Race/Ethnicity, Customized Caucasian | 155 participants | 156 participants | 311 participants |
| Race/Ethnicity, Customized Hispanic | 20 participants | 16 participants | 36 participants |
| Race/Ethnicity, Customized Other | 17 participants | 10 participants | 27 participants |
| Sex/Gender, Customized Women | 239 participants | 236 participants | 475 participants |
| Tobacco use during pregnancy No | 190 participants | 195 participants | 385 participants |
| Tobacco use during pregnancy Yes | 49 participants | 41 participants | 90 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 239 | 19 / 236 |
| serious Total, serious adverse events | 3 / 239 | 3 / 236 |
Outcome results
Primary
Silver Treatment Efficacy
As measured by number of patients with postop infections at 6 wks
Time frame: 6 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Silver-containing Surgical Dressing | Silver Treatment Efficacy | 25 participants |
| Cloth Adhesive Dressing | Silver Treatment Efficacy | 19 participants |
p-value: 0.365Chi-squared
Secondary
Infection Rate Adjusted for Maternal BMI
Time frame: 6 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Silver-containing Surgical Dressing | Infection Rate Adjusted for Maternal BMI | 10 percentage of participants |
| Cloth Adhesive Dressing | Infection Rate Adjusted for Maternal BMI | 8 percentage of participants |
p-value: 0.282Mixed Models Analysis
Secondary
Patient Dressing Cost
Total cost of dressings per group based on 1 dressing per patient
Time frame: Postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Silver-containing Surgical Dressing | Patient Dressing Cost | 11,080.04 dollars |
| Cloth Adhesive Dressing | Patient Dressing Cost | 306.80 dollars |