Trial Outcomes & Findings for Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions (NCT NCT02212977)

Results Overview

To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

3 months

Results posted on

2016-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Suture Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture	Octylcyanoacrylate Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate
Overall Study STARTED	55	54
Overall Study COMPLETED	50	48
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suture n=55 Participants Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture	Octylcyanoacrylate n=54 Participants Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate	Total n=109 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 7.5 • n=5 Participants	58.3 years STANDARD_DEVIATION 7.6 • n=7 Participants	58.7 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	35 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	19 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.

Outcome measures

Outcome measures
Measure	Suture n=50 Participants Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture	Octylcyanoacrylate n=48 Participants Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate
Number of Participants With Complication of Wound Dehiscence	0 participants	0 participants

PRIMARY outcome

Timeframe: 3 months

To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.

Outcome measures

Outcome measures
Measure	Suture n=50 Participants Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture	Octylcyanoacrylate n=48 Participants Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate
Number of Participants With Complication of Infection	2 participants	1 participants

SECONDARY outcome

Timeframe: 3 months

Population: Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis.

To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.

Outcome measures

Outcome measures
Measure	Suture n=45 Participants Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture	Octylcyanoacrylate n=41 Participants Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate
Healing-incision Cosmesis Score by Visual Analogue Scale	4.46 units on a scale Standard Deviation 2.4	4.4 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline

To compare closure time and associated costs between these two methods of skin closure.

Outcome measures

Outcome measures
Measure	Suture n=55 Participants Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture	Octylcyanoacrylate n=54 Participants Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate
Closure Time	8.6 minutes Standard Deviation 3.7	1.6 minutes Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline

Per unit cost for suture and octylcyanoacrylate

Outcome measures

Outcome measures
Measure	Suture n=55 Participants Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture	Octylcyanoacrylate n=54 Participants Skin incision closure with topic skin adhesive Octylcyanoacrylate Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate
Closure Materials Cost	2.54 dollars	25.92 dollars

Adverse Events

Suture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Octylcyanoacrylate

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. Charles Kim

Duke University Medical Center

Phone: 9196847424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place