Trial Outcomes & Findings for Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization (NCT NCT01035944)
NCT ID: NCT01035944
Last Updated: 2014-07-01
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
2 days and 5 days after debridement.
Results posted on
2014-07-01
Participant Flow
Participant milestones
| Measure |
HemCon Operating Room
The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.
|
Control Operating Room
The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings.
|
HemCon Bedside
The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.
|
Control Bedside.
The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
5
|
4
|
|
Overall Study
COMPLETED
|
11
|
13
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization
Baseline characteristics by cohort
| Measure |
HemCon Operating Room
n=14 Participants
The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.
|
Control Operating Room
n=14 Participants
The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings.
|
HemCon Bedside
n=5 Participants
The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.
|
Control Bedside.
n=4 Participants
The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.43 years
STANDARD_DEVIATION 20.0 • n=5 Participants
|
51.64 years
STANDARD_DEVIATION 16.2 • n=7 Participants
|
70.80 years
STANDARD_DEVIATION 19.9 • n=5 Participants
|
64.50 years
STANDARD_DEVIATION 20.8 • n=4 Participants
|
57.05 years
STANDARD_DEVIATION 19.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
37 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 days and 5 days after debridement.Population: Zero participant data were analyzed. Study was terminated early; unable to reach enrollment milestones.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 days and 5 days after debridement.Outcome measures
Outcome data not reported
Adverse Events
HemCon Operating Room
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Operating Room
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
HemCon Bedside
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Bedside.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HemCon Operating Room
n=14 participants at risk
The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.
|
Control Operating Room
n=14 participants at risk
The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings.
|
HemCon Bedside
n=5 participants at risk
The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings.
|
Control Bedside.
n=4 participants at risk
The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.
Gauze and saline dressings.: Control for both settings will be gauze and saline dressings.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Embolism
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Acute Stroke
|
0.00%
0/14
|
0.00%
0/14
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Bleeding Wound
|
7.1%
1/14 • Number of events 3
|
7.1%
1/14 • Number of events 2
|
0.00%
0/5
|
0.00%
0/4
|
|
Infections and infestations
Significant amount of bacteria in wound
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
transfusion reaction
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Wound hematoma
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60