Clinical Trials Logo
  1. Home
  2. Wounds
  3. NCT01514383
  4. Details
NCT01514383 Clinical Trial

Octylseal Surgical Adhesive in General Surgery

Wounds Clinical Trial

Official title:
Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01514383
Other study ID # R11-009
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2012
Est. completion date October 2012

Study information
Verified date May 2019
Source Medline Industries
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cyanoacrylate (Octylseal )
surgical adhesive

Locations
Country Name City State
United States Jersey City Medical Center Jersey City New Jersey
United States Wyckoff Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound Length Closure Primary incision wound length treatment in adult and pediatric general surgery During Surgery
Secondary Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst At Surgery
See also
  Status Clinical Trial Phase
Completed NCT02865902 - Low-level Laser Therapy in Enhancing Wound Healing and Preserving Tissue Thickness N/A
Terminated NCT01191567 - Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life N/A
Completed NCT01227759 - Tyrosur® Gel-Investigation on Wound Healing Efficacy Phase 2
Recruiting NCT00737425 - Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery Phase 4
Completed NCT00746109 - Study of Wound Packing After Superficial Skin Abscess Drainage Phase 4
Terminated NCT00762138 - The AutoloGel™ Post-Market Surveillance (TAPS) Program N/A
Withdrawn NCT00234559 - Trial of Vacuum Assisted Closure® Therapy Versus Control Therapy in Angiogenesis N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05588583 - A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. N/A
Completed NCT02591537 - OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University N/A
Completed NCT00792688 - Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation Phase 2
Recruiting NCT05608317 - A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing N/A
Recruiting NCT02195063 - Survey Study for Pain Management, Wound Care, Scar Care or UDT Phase 4
Completed NCT01319149 - A Study of the Effects of Molecular Diagnostic Directed Wound Gels on Wound Care Outcomes N/A
Completed NCT00153452 - Workplace Productivity of Persons Who Use Controlling Behavior With Intimate Partners N/A
Completed NCT06083740 - A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
Not yet recruiting NCT02672280 - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects Phase 1/Phase 2
Withdrawn NCT02314416 - Stem Cells In Wound Healing With Collagen Matrix as a Carrier Phase 4
Recruiting NCT01454167 - Acid Base and Electrolytes Patterns in Drains Operational Wounds and Its Relation to Complications N/A