Trial Outcomes & Findings for Topical Silver for Prevention of Wound Infection After Cesarean Delivery (NCT NCT01169064)
NCT ID: NCT01169064
Last Updated: 2017-05-30
Results Overview
As measured by number of patients with postop infections at 6 wks
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
475 participants
Primary outcome timeframe
6 weeks postpartum
Results posted on
2017-05-30
Participant Flow
31 patients were removed from the study after consent but prior to study start, these participants did not meet inclusion / exclusion criteria
Participant milestones
| Measure |
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
|
Cloth Adhesive Dressing
Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
|
|---|---|---|
|
Overall Study
STARTED
|
239
|
236
|
|
Overall Study
COMPLETED
|
239
|
236
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Silver for Prevention of Wound Infection After Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Silver-containing Surgical Dressing
n=239 Participants
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
|
Cloth Adhesive Dressing
n=236 Participants
Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
|
Total
n=475 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
16-25
|
71 years
n=5 Participants
|
88 years
n=7 Participants
|
159 years
n=5 Participants
|
|
Age, Customized
26-35
|
143 years
n=5 Participants
|
113 years
n=7 Participants
|
256 years
n=5 Participants
|
|
Age, Customized
36-45
|
24 years
n=5 Participants
|
30 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex/Gender, Customized
Women
|
239 participants
n=5 Participants
|
236 participants
n=7 Participants
|
475 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
155 participants
n=5 Participants
|
156 participants
n=7 Participants
|
311 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
43 participants
n=5 Participants
|
50 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 participants
n=5 Participants
|
10 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Average BMI
|
32.0 kg/m^2
n=5 Participants
|
32.8 kg/m^2
n=7 Participants
|
32.4 kg/m^2
n=5 Participants
|
|
Tobacco use during pregnancy
Yes
|
49 participants
n=5 Participants
|
41 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Tobacco use during pregnancy
No
|
190 participants
n=5 Participants
|
195 participants
n=7 Participants
|
385 participants
n=5 Participants
|
|
No use of alcohol during pregnancy
|
239 participants
n=5 Participants
|
236 participants
n=7 Participants
|
475 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postpartumAs measured by number of patients with postop infections at 6 wks
Outcome measures
| Measure |
Silver-containing Surgical Dressing
n=239 Participants
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
|
Cloth Adhesive Dressing
n=236 Participants
Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
|
|---|---|---|
|
Silver Treatment Efficacy
|
25 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumOutcome measures
| Measure |
Silver-containing Surgical Dressing
n=239 Participants
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
|
Cloth Adhesive Dressing
n=236 Participants
Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
|
|---|---|---|
|
Infection Rate Adjusted for Maternal BMI
|
10 percentage of participants
Interval 6.5 to 13.5
|
8 percentage of participants
Interval 4.1 to 11.9
|
SECONDARY outcome
Timeframe: PostoperativeTotal cost of dressings per group based on 1 dressing per patient
Outcome measures
| Measure |
Silver-containing Surgical Dressing
n=239 Participants
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
|
Cloth Adhesive Dressing
n=236 Participants
Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
|
|---|---|---|
|
Patient Dressing Cost
|
11,080.04 dollars
|
306.80 dollars
|
Adverse Events
Silver-containing Surgical Dressing
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Cloth Adhesive Dressing
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Silver-containing Surgical Dressing
n=239 participants at risk
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
No adverse events
|
Cloth Adhesive Dressing
n=236 participants at risk
Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
No adverse events
|
|---|---|---|
|
Infections and infestations
Readmission to hospital for Infection
|
1.3%
3/239 • Number of events 3 • 2 years
|
1.3%
3/236 • Number of events 3 • 2 years
|
Other adverse events
| Measure |
Silver-containing Surgical Dressing
n=239 participants at risk
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
No adverse events
|
Cloth Adhesive Dressing
n=236 participants at risk
Soft cloth adhesive wound dressing
Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
No adverse events
|
|---|---|---|
|
Infections and infestations
Wound Infection
|
10.5%
25/239 • Number of events 25 • 2 years
|
8.1%
19/236 • Number of events 19 • 2 years
|
Additional Information
Dr. Kelly Bennett; Director of Maternal Fetal Medicine
Vanderbilt University Medical Ctr., Dept OB/GYN
Phone: 6153436275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place