Octylseal Surgical Adhesive in General Surgery
Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series
1 other identifier
interventional
34
1 country
2
Brief Summary
The purpose of this study is to evaluate how surgical adhesive is used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2012
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 12, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
May 7, 2019
CompletedMay 7, 2019
May 1, 2019
8 months
January 12, 2012
August 28, 2017
May 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound Length Closure
Primary incision wound length treatment in adult and pediatric general surgery
During Surgery
Secondary Outcomes (1)
Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale
At Surgery
Study Arms (1)
Surgical Adhesive
EXPERIMENTALThe surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures.
Interventions
Eligibility Criteria
You may qualify if:
- Candidate for use of a topical surgical skin adhesive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
Wyckoff Hospital
New York, New York, 11237, United States
MeSH Terms
Conditions
Results Point of Contact
- Title
- Ed Drower, Clinical Project Director
- Organization
- Medline Industries, Inc
Study Officials
- STUDY DIRECTOR
Ed Drower, MS
Medline Industries
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2012
First Posted
January 23, 2012
Study Start
January 1, 2012
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
May 7, 2019
Results First Posted
May 7, 2019
Record last verified: 2019-05