Octylseal Surgical Adhesive in General Surgery

• Sponsor: Medline Industries (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01514383
• Collaborator: (none)
• Enrollment: 34
• Locations: 2
• Arm: 1
• Duration (Months): 9
• Patients Per Site: 17
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate how surgical adhesive is used.

Condition or Disease	Intervention/Treatment	Phase
Wounds	Device: Cyanoacrylate (Octylseal )	Phase 4

Detailed Description

In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgical Adhesive The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures.	Device: Cyanoacrylate (Octylseal ); surgical adhesive; Other Names: cyanoacrylate

Outcome Measures

Primary Outcome Measures

1. Wound Length Closure [During Surgery]

   Primary incision wound length treatment in adult and pediatric general surgery

Secondary Outcome Measures

1. Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale [At Surgery]

   Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Candidate for use of a topical surgical skin adhesive

Exclusion Criteria:

• Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)

• Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history

• Subjects who present with a contraindications for product usage as per labeling

• A wound with evidence of active infection or gangrene or wounds of decubitus etiology

• Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to bodily fluids or with dense natural hair

• Subjects with known hypersensitivity to cyanoacrylate or formaldehyde

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jersey City Medical Center	Jersey City	New Jersey	United States	07302
2	Wyckoff Hospital	New York	New York	United States	11237

Sponsors and Collaborators

• Medline Industries

Investigators

• Study Director: Ed Drower, MS, Medline Industries

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medline Industries
• ClinicalTrials.gov Identifier: NCT01514383
• Other Study ID Numbers: R11-009
• First Posted: Jan 23, 2012
• Last Update Posted: May 7, 2019
• Last Verified: May 1, 2019

• Keywords provided by Medline Industries: wounds

Study Results

Participant Flow

Arm/Group Title	Surgical Adhesive
Arm/Group Description	Cyanoacrylate (Octylseal ): surgical adhesive
Period Title: Overall Study
STARTED	34
COMPLETED	34
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Octylseal
Arm/Group Description
Overall Participants	34
Age (years) [Mean (Standard Deviation) ]
Adult	47.5 (17.5)
Pediatric	11.3 (2.8)
Sex: Female, Male (Count of Participants)
Female	17 50%
Male	17 50%
Region of Enrollment (Count of Participants)
United States	34 100%

Outcome Measures

1. Primary Outcome

Title	Wound Length Closure
Description	Primary incision wound length treatment in adult and pediatric general surgery
Time Frame	During Surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wound Length Closure of Paticipants Treated With Octylseal
Arm/Group Description
Measure Participants	34
Adult	28.97 (24.68)
Pediatric	21.00 (10.98)

2. Secondary Outcome

Title	Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale
Description	Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst
Time Frame	At Surgery

Outcome Measure Data

Analysis Population Description

All 34 participants

Arm/Group Title	No Pain Reported
Arm/Group Description	Wong-Baker FACES™ Pain Rating Scale Pain Rating Scale from 0-10, with 0 =No Hurt to 10=Hurts Worst
Measure Participants	34
Count of Participants [Participants]	34 100%

Adverse Events

Time Frame	14 days
Arm/Group Title	Octylseal
Arm/Group Description
All Cause Mortality
	Octylseal
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Serious Adverse Events
	Octylseal
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	Octylseal
	Affected / at Risk (%)	# Events
Total	1/34 (2.9%)
Infections and infestations
Infection	1/34 (2.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.