Trial Outcomes & Findings for Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin (NCT NCT01290978)

Results Overview

The peel force to remove the sample

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

30 minutes

Results posted on

2024-10-02

Participant Flow

Study was conducted between 22 Feb and 5 March 2010. Twenty-four male or female healthy volunteers between ages of 18 and 65 were screened for this study in order to ensure that at least 20 volunteers were enrolled. Volunteers were recruited from a pool of suburban men/women who met the exclusion/inclusion criteria.

Volunteers who met the exclusion/inclusion criteria were required to undergo a 1-day washout period where they were not allowed to use any moisturizing products or other skin contact materials on their backs. Two subjects were screen failures.

Participant milestones

Participant milestones
Measure	ChloraPrep, DuraPrep Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ChloraPrep , DuraPrep n=22 Participants Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
Age, Continuous	40.4 participants STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: Data analysis per protocol

The peel force to remove the sample

Outcome measures

Outcome measures
Measure	ChloraPrep n=22 Participants Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.	DuraPrep n=22 Participants Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
Drape Adhesion	78.6 grams-force Interval 68.0 to 89.2	181.3 grams-force Interval 165.8 to 196.8

SECONDARY outcome

Timeframe: 30 minutes

Population: The number of participants was determined to provide 80% power to detect a difference of 20% for the drape by prep comparisons

Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction)

Outcome measures

Outcome measures
Measure	ChloraPrep n=22 Participants Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.	DuraPrep n=22 Participants Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively Skin assessment on Ioban application site	0.67 units on a scale Standard Deviation 0.52	0.98 units on a scale Standard Deviation 0.62
Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively Skin assessment on ActiGard application site	0.31 units on a scale Standard Deviation 0.44	0.90 units on a scale Standard Deviation 0.65
Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively Skin assessment on Steri-Drape 2 application site	0.30 units on a scale Standard Deviation 0.43	0.95 units on a scale Standard Deviation 0.58

Adverse Events

ChloraPrep, DuraPrep

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

Dr. Gary Grove

cyberDERM Clinical Studies

Phone: 610-325-0112

Results disclosure agreements

Principal investigator is a sponsor employee Restriction for PI to publish trial results without review and approval by sponsor
Publication restrictions are in place

Restriction type: OTHER