Trial Outcomes & Findings for Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing (NCT NCT00618787)

NCT ID: NCT00618787

Last Updated: 2010-04-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2010-04-15

Participant Flow

The first study subject was randomized on March 5, 2008 and the last subject visit was conducted on February 18, 2009. Subjects were screened for eligibility, consented, enrolled and randomized at two participating wound care clinics.

Participant milestones

Measure	COPA AMD Foam dressing impregnated with Polyhexamethylene Biguanide	COPA Regular foam dressing without Polyhexamethylene Biguanide
Overall Study STARTED	22	23
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	COPA AMD Foam dressing impregnated with Polyhexamethylene Biguanide	COPA Regular foam dressing without Polyhexamethylene Biguanide
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing

Baseline characteristics by cohort

Measure	COPA AMD n=22 Participants Foam dressing impregnated with Polyhexamethylene Biguanide	COPA n=23 Participants Regular foam dressing without Polyhexamethylene Biguanide	Total n=45 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	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Age Continuous	56.4 years STANDARD_DEVIATION 15.28 • n=5 Participants	55.1 years STANDARD_DEVIATION 11.01 • n=7 Participants	55.8 years STANDARD_DEVIATION 13.13 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Canada	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Weeks 0 and 4

Population: Per protocol

At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.

Outcome measures

Measure	COPA AMD n=19 Participants Foam dressing impregnated with Polyhexamethylene Biguanide	COPA n=21 Participants Regular foam dressing without Polyhexamethylene Biguanide
Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.	34.9 Percentage change Interval -74.8 to 94.7	27.8 Percentage change Interval -167.0 to 97.6

SECONDARY outcome

Timeframe: 5 weeks

Outcome measures

Outcome data not reported

Adverse Events

COPA AMD

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

COPA

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	COPA AMD n=22 participants at risk Foam dressing impregnated with Polyhexamethylene Biguanide	COPA n=23 participants at risk Regular foam dressing without Polyhexamethylene Biguanide
Cardiac disorders cardiac stent implanted	0.00% 0/22 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	4.3% 1/23 • Number of events 1 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Respiratory, thoracic and mediastinal disorders pulmonary embolus	0.00% 0/22 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	4.3% 1/23 • Number of events 1 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.

Other adverse events

Measure	COPA AMD n=22 participants at risk Foam dressing impregnated with Polyhexamethylene Biguanide	COPA n=23 participants at risk Regular foam dressing without Polyhexamethylene Biguanide
Ear and labyrinth disorders Head, eyes, ears, nose and throat	9.1% 2/22 • Number of events 2 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	0.00% 0/23 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Skin and subcutaneous tissue disorders Skin/Dermatologic (not including study wound)	9.1% 2/22 • Number of events 4 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	8.7% 2/23 • Number of events 3 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Skin and subcutaneous tissue disorders Wound Infection	0.00% 0/22 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	8.7% 2/23 • Number of events 2 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Metabolism and nutrition disorders Endocrine, metabolic and nutritional	4.5% 1/22 • Number of events 1 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	0.00% 0/23 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Endocrine disorders Allergic and immunologic	0.00% 0/22 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	4.3% 1/23 • Number of events 1 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Musculoskeletal and connective tissue disorders Musculoskeletal	0.00% 0/22 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	4.3% 1/23 • Number of events 2 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Gastrointestinal disorders Digestive/Gastrointestinal	0.00% 0/22 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	4.3% 1/23 • Number of events 1 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Renal and urinary disorders Urogenital	0.00% 0/22 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	4.3% 1/23 • Number of events 1 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.
Blood and lymphatic system disorders Hematopoietic/Lymphatic	0.00% 0/22 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.	4.3% 1/23 • Number of events 1 • One year Adverse events were assessed during each study visit (bi-weekly clinic visits) and as they occurred (e.g., adverse event is reported to the research team by subject, family member or other healthcare professional). Assessment type was a protocol specific coding system based on anticipated adverse events and physiological systems.

Additional Information

Tonya Eggleston, RN, MPH, Study Director

Tyco Healthcare Group

Phone: (508) 261-8420

Email: Tonya.Eggleston@Covidien.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place