Trial Outcomes & Findings for Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery (NCT NCT03887299)
NCT ID: NCT03887299
Last Updated: 2021-10-05
Results Overview
We will be assessing through a survey patient satisfaction concerning dressing received and assess the quality of life while receiving either intervention (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
154 participants
Primary outcome timeframe
Postpartum wound care visit (up to 10days postpartum)
Results posted on
2021-10-05
Participant Flow
Participant milestones
| Measure |
Standard Wound Care
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
Standard Wound Care: Wound care will be administered as standard protocol in our institution
|
CHG Wound Care
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
COMPLETED
|
77
|
77
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Standard Wound Care
n=77 Participants
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
Standard Wound Care: Wound care will be administered as standard protocol in our institution
|
CHG Wound Care
n=77 Participants
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
n=93 Participants
|
29 years
n=4 Participants
|
29 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
154 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=93 Participants
|
77 participants
n=4 Participants
|
154 participants
n=27 Participants
|
|
Medical Condition
|
27 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Delivery complications
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Vertical Skin incision
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Skin closure with staples
|
44 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Postpartum wound care visit (up to 10days postpartum)We will be assessing through a survey patient satisfaction concerning dressing received and assess the quality of life while receiving either intervention (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.
Outcome measures
| Measure |
Standard Wound Care
n=77 Participants
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
Standard Wound Care: Wound care will be administered as standard protocol in our institution
|
CHG Wound Care
n=77 Participants
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
|
|---|---|---|
|
Satisfaction and QoL Questionnaire
|
49 Score
Interval 20.0 to 55.0
|
52 Score
Interval 12.0 to 55.0
|
SECONDARY outcome
Timeframe: 30 days postpartumDefined as presence of any of the following within 30 days from surgery: Wound infection: Presence of either superficial or deep incisional SSI described as cellulitis/erythema and induration around the incision or purulent discharge from the incision site, with or without fever, such as necrotizing fasciitis (diagnosed based on necrotizing wound infection). Wound hematoma, seroma, or breakdown alone. (yes or No)
Outcome measures
| Measure |
Standard Wound Care
n=77 Participants
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
Standard Wound Care: Wound care will be administered as standard protocol in our institution
|
CHG Wound Care
n=77 Participants
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
|
|---|---|---|
|
Number of Participants With Composite Wound Complication
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 days postpartumOpening of wound incision documented in the chart at the provider's discretion(Yes or No)
Outcome measures
| Measure |
Standard Wound Care
n=77 Participants
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
Standard Wound Care: Wound care will be administered as standard protocol in our institution
|
CHG Wound Care
n=77 Participants
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
|
|---|---|---|
|
Number of Participants With Wound Breakdown
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 days postpartumDeath of participant during hospital stay (Yes or No)
Outcome measures
| Measure |
Standard Wound Care
n=77 Participants
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
Standard Wound Care: Wound care will be administered as standard protocol in our institution
|
CHG Wound Care
n=77 Participants
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
|
|---|---|---|
|
Number of Participants That Resulted in Maternal Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 days postpartumTemperature \> 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)
Outcome measures
| Measure |
Standard Wound Care
n=77 Participants
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
Standard Wound Care: Wound care will be administered as standard protocol in our institution
|
CHG Wound Care
n=77 Participants
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
|
|---|---|---|
|
Number of Participants With Puerperal Fever
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Postpartum wound care visit (up to 10days postpartum)Assessing health care providers opinion on the dressing care (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.
Outcome measures
| Measure |
Standard Wound Care
n=77 Participants
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.
Standard Wound Care: Wound care will be administered as standard protocol in our institution
|
CHG Wound Care
n=77 Participants
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.
ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG): Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
|
|---|---|---|
|
Provider Satisfaction
|
17 Score
Interval 5.0 to 25.0
|
21 Score
Interval 5.0 to 25.0
|
Adverse Events
Standard Wound Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHG Wound Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Antonio F Saad
University of Texas Medical Branch Galveston
Phone: 4097476646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place