Trial Outcomes & Findings for Wound Fluid Protease Levels During Use of Novel Wound Dressing (NCT NCT01567150)

Results Overview

Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-11-25

Participant Flow

4 subjects attended only one study visit thus did not have evaluable data

Participant milestones

Participant milestones
Measure	Novel Dressing Treatment with novel dressing Novel Dressing: Topical wound dressing	Control Control is treatment without novel dressing
Overall Study STARTED	21	18
Overall Study COMPLETED	19	16
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wound Fluid Protease Levels During Use of Novel Wound Dressing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Novel Dressing n=19 Participants Treatment with novel dressing Novel Dressing: Topical wound dressing	Control n=16 Participants Control is treatment without novel dressing	Total n=35 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 14.9 • n=5 Participants	60.6 years STANDARD_DEVIATION 12.9 • n=7 Participants	58.1 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Overall mean across 8 week timeframe

Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.

Outcome measures

Outcome measures
Measure	Novel Dressing n=19 Participants Treatment with novel dressing Novel Dressing: Topical wound dressing	Control n=16 Participants Control is treatment without novel dressing
Matrix Metalloproteinase Level in Wound Fluid	0.71 mcg/ml Standard Deviation 0.78	0.88 mcg/ml Standard Deviation 0.85

SECONDARY outcome

Timeframe: 12 weeks

Population: average across 12 week time frame

change in wound area mean was calculated for each subject Mean and sd were calculated for each group

Outcome measures

Outcome measures
Measure	Novel Dressing n=19 Participants Treatment with novel dressing Novel Dressing: Topical wound dressing	Control n=16 Participants Control is treatment without novel dressing
Wound Healing	-4.99 square cm Standard Deviation 8.22	-2.49 square cm Standard Deviation 6.45

Adverse Events

Novel Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Director, Global Clinical Affairs

Hollister Incorporated

Phone: 8479183996

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60