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Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01528696
Recruitment Status : Terminated (Insufficient Recruitment)
First Posted : February 8, 2012
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Cura Surgical
Information provided by (Responsible Party):
Mark Chames, MD, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Obesity
Complications; Caesarean Section, Wound
Interventions Device: Silverlon
Device: Standard Dressing
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Dressing Silverlon
Hide Arm/Group Description

Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing

Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing

Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.

Period Title: Overall Study
Started 18 19
Hospital Stay (2-5 Days) 18 19
Completed 0 0
Not Completed 18 19
Reason Not Completed
See detailed description             18             19
Arm/Group Title Standard Dressing Silverlon Total
Hide Arm/Group Description

Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing

Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing

Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.

Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
19
 100.0%
37
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
18
 100.0%
19
 100.0%
37
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 19 participants 37 participants
18 19 37
1.Primary Outcome
Title Number of Patients Who Experience One or More Wound Complications
Hide Description A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.
Arm/Group Title Standard Dressing Silverlon
Hide Arm/Group Description:

Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing

Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing

Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Febrile Morbidity
Hide Description Febrile morbidity would be measured by number of participants who experienced fever as a sign of infection at 2 days, and overall within 6 weeks of delivery.
Time Frame 2 days, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.
Arm/Group Title Standard Dressing Silverlon
Hide Arm/Group Description:

Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing

Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing

Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Patient Report of Pain Severity and Control
Hide Description Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.
Arm/Group Title Standard Dressing Silverlon
Hide Arm/Group Description:

Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing

Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing

Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The original intent was to pull adverse event data from the medical record in batches as the study progressed. Because enrollment ceased early with insufficient numbers to draw conclusions, no adverse event data was collected in study. Therefore the 0 numbers affected listed below in serious and other adverse events represent no collected data of adverse events, not a guarantee that no adverse events happened. All participants were under medical care with attending physicians at all times.
 
Arm/Group Title Standard Dressing Silverlon
Hide Arm/Group Description

Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing

Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing

Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.

All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.

All-Cause Mortality
Standard Dressing Silverlon
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Standard Dressing Silverlon
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Dressing Silverlon
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Chames
Organization: University of Michigan
Phone: 734 764-1406
EMail: mchames@med.umich.edu
Layout table for additonal information
Responsible Party: Mark Chames, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01528696    
Other Study ID Numbers: HUM00037674
First Submitted: February 1, 2012
First Posted: February 8, 2012
Results First Submitted: December 22, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017