Trial Outcomes & Findings for Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section (NCT NCT01528696)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Dressing 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.	Silverlon 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 Study STARTED	18	19
Overall Study Hospital Stay (2-5 Days)	18	19
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	18	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Dressing 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.	Silverlon 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 Study See detailed description	18	19

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Dressing n=18 Participants 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.	Silverlon n=19 Participants 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 n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	19 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 days, 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain

Outcome measures

Outcome data not reported

Adverse Events

Standard Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Silverlon

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

Mark Chames

University of Michigan

Phone: 734 764-1406

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place