Skin Incision Adhesive in Pediatrics

• Sponsor: Medline Industries (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01514396
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 17.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).

Condition or Disease	Intervention/Treatment	Phase
Wounds	Device: Surgiseal	N/A

Detailed Description

Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Surgiseal as a Topical Emergency Department Skin Incision Adhesive in Pediatrics A Case Series
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgical Glue Surgiseal	Device: Surgiseal; surgical glue

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Wound Closure [baseline to 14 days]

   wound closure measured baseline to 14 days

Secondary Outcome Measures

1. Adverse Events Related to Wound Closure [14 days]

   Adverse events reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Between the ages of 5 and 18 years of age, inclusive

• Candidate for use of a topical surgical skin adhesive

• Informed consent by a parental guardian

Exclusion Criteria:

• 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 body fluids or dense natural hair

• Subjects with known hypersensitivity to cyanoacrylate or formaldehyde

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akron Children's Hospital Emergency Department	Akron	Ohio	United States	44308

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: NCT01514396
• Other Study ID Numbers: R11-018
• First Posted: Jan 23, 2012
• Last Update Posted: Dec 4, 2018
• Last Verified: Aug 1, 2017

• Keywords provided by Medline Industries: Pediatric; Wounds

Study Results

Participant Flow

Arm/Group Title	Surgical Glue
Arm/Group Description	Surgiseal Surgiseal: surgical glue To determine if SurgiSeal™ can effectively seal epidermal wounds in children while not causing any adverse events.
Period Title: Overall Study
STARTED	8
COMPLETED	8
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Surgical Glue
Arm/Group Description	Surgiseal Surgiseal: surgical glue
Overall Participants	8
Age (Count of Participants)
<=18 years	8 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 25%
Male	6 75%
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Wound Closure
Description	wound closure measured baseline to 14 days
Time Frame	baseline to 14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Wound Closure
Arm/Group Description	Number of Participants with Wound Closure baseline to 14 days from discharge
Measure Participants	8
Number [participants]	8 100%

2. Secondary Outcome

Title	Adverse Events Related to Wound Closure
Description	Adverse events reported
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adverse Events Related to Wound Closure
Arm/Group Description	Adverse Events related to wound closure with study product
Measure Participants	8
Number [participants]	0 0%

Adverse Events

Time Frame	baseline to 14 days
Arm/Group Title	Surgical Glue
Arm/Group Description	Surgiseal Surgiseal: surgical glue
All Cause Mortality
	Surgical Glue
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Serious Adverse Events
	Surgical Glue
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Surgical Glue
	Affected / at Risk (%)	# Events
Total	0/8 (0%)

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.