184 Participants Needed

Tissue Adhesives for Surgical Port Closure

AR
JH
Overseen ByJulie Holihan
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment 2-Octylcyanoacrylate (Dermabond) for surgical port closure?

Research shows that 2-Octylcyanoacrylate (Dermabond) is effective for closing surgical skin incisions, providing a strong barrier against microorganisms, and offering cosmetic results comparable to traditional methods. It has been successfully used in various procedures, including laparoscopic surgeries and circumcisions, with faster closure times and good cosmetic outcomes.12345

Is Dermabond (2-octyl cyanoacrylate) generally safe for use in humans?

Dermabond is generally safe for use in humans, but some people may experience allergic reactions, such as skin rashes and itching, after its application. In a study, about 6.6% of patients developed an allergic reaction, so it's important to be aware of this possibility.24678

How is the treatment 2-Octylcyanoacrylate different from other treatments for surgical port closure?

2-Octylcyanoacrylate (Dermabond) is unique because it acts as a tissue 'glue' that closes wounds without the need for stitches, reducing the risk of infection and providing a strong barrier against bacteria. It is easy to apply and offers cosmetic results that are as good as or better than traditional methods.134910

Eligibility Criteria

This trial is for adults over 18 who are scheduled for elective laparoscopic or robotic abdominal surgery. It's not suitable for those with allergies to the tissue adhesives being tested or individuals who may not be able to attend follow-up appointments, such as living out of state.

Inclusion Criteria

I am scheduled for a minimally invasive abdominal surgery.
I am 18 years old or older.

Exclusion Criteria

Patients unlikely to follow-up (live out of state, unable to be reached by phone or email)
You are allergic to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo elective laparoscopic or robotic abdominal surgery with application of surgical glues

1 day
1 visit (in-person)

Follow-up

Participants are monitored for contact dermatitis and other skin reactions post-surgery

6 weeks
Multiple visits (in-person)

Treatment Details

Interventions

  • 2-Octylcyanoacrylate
  • 2-Octylcyanoacrylate (Dermabond)
  • N-butyl-2-cyanoacrylate
Trial OverviewThe study compares two types of tissue adhesives: 2-Octylcyanoacrylate and N-butyl-2-cyanoacrylate, used in closing surgical port sites after abdominal procedures. Participants will be randomly assigned one of these methods.
Participant Groups
2Treatment groups
Active Control
Group I: DermabondActive Control2 Interventions
Dermabond over incisions
Group II: SwiftsetActive Control2 Interventions
Swiftset over incisions

2-Octylcyanoacrylate is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Dermabond for:
  • Closure of skin wounds with easily approximated edges
  • Combination with subcuticular sutures for deeper or higher tension wounds
🇨🇦
Approved in Canada as Dermabond for:
  • Closure of skin wounds with easily approximated edges
  • Combination with subcuticular sutures for deeper or higher tension wounds
🇪🇺
Approved in European Union as Dermabond for:
  • Closure of skin wounds with easily approximated edges
  • Combination with subcuticular sutures for deeper or higher tension wounds

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Findings from Research

Using octylcyanoacrylate (Dermabond) for closing laparoscopic trocar sites significantly reduces closure time to an average of 3.7 minutes compared to 14 minutes for subcuticular sutures, making it a faster option for surgeons.
The use of octylcyanoacrylate also results in substantial cost savings, averaging $198 per closure compared to $497 for sutures, while showing similar rates of wound complications, indicating it is both effective and economical.
Octylcyanoacrylate skin closure in laparoscopy.Sebesta, MJ., Bishoff, JT.[2016]
In a study of 46 inguinal herniorrhaphy incisions, using 2-octylcyanoacrylate tissue adhesive (Dermabond) resulted in significantly faster closure times compared to traditional subcuticular sutures (155 seconds vs. 286 seconds).
However, the Dermabond group experienced a higher rate of wound complications, leading the researchers to conclude that Dermabond is not a suitable alternative to subcuticular sutures for this type of surgical incision.
Subcuticular closure versus Dermabond: a prospective randomized trial.Switzer, EF., Dinsmore, RC., North, JH.[2016]
In an in vitro study, Dermabond Topical Skin Adhesive (2-octylcyanoacrylate) demonstrated a 99% efficacy in preventing microbial penetration for up to 72 hours, based on tests involving 600 films.
The adhesive effectively blocked both gram-positive and gram-negative bacteria, indicating its potential as a safe and effective alternative for wound closure compared to traditional methods.
In vitro assessment of microbial barrier properties of Dermabond topical skin adhesive.Bhende, S., Rothenburger, S., Spangler, DJ., et al.[2022]

References

Octylcyanoacrylate skin closure in laparoscopy. [2016]
Subcuticular closure versus Dermabond: a prospective randomized trial. [2016]
In vitro assessment of microbial barrier properties of Dermabond topical skin adhesive. [2022]
Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. [2016]
Octyl-2-cyanoacrylate as a routine dressing after open pediatric urological procedures. [2019]
Dermabond skin closures for bilateral reduction mammaplasties: a review of 255 consecutive cases. [2021]
Type IV Hypersensitivity Reaction to Dermabond (2-Octyl Cyanoacrylate) in Plastic Surgical Patients: A Retrospective Study. [2023]
Diffuse cutaneous allergic reaction to Dermabond. [2022]
Octylcyanoacrylate tissue adhesive versus suture wound repair in a contaminated wound model. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Octylcyanoacrylate skin closure in laparoscopy. [2022]