Tissue Adhesives for Surgical Port Closure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Disqualifiers: Allergy to cyanoacrylate, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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.
12345Is 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.
24678How 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.
134910Eligibility 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.
Trial 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)
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
Memorial HermannHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
Octylcyanoacrylate skin closure in laparoscopy. [2016]Octylcyanoacrylate (Dermabond) is a tissue "glue" useful in closing surgical skin incisions. We compared skin octylcyanoacrylate with subcuticular skin sutures to close laparoscopic trocar sites.
Subcuticular closure versus Dermabond: a prospective randomized trial. [2016]2-Octylcyanoacrylate tissue adhesive (Dermabond, Ethicon, Inc, Somerville, NJ) is being used successfully for closure of minor lacerations. To date, however, there have been no studies evaluating its use in the operating room for surgical incisions. We conducted a prospective randomized trial to compare the closure of inguinal herniorrhaphy incisions using 2-octylcyanoacrylate tissue adhesive (Dermabond) with closures using 4-0 Monocryl (Ethicon, Inc) in a running subcuticular closure. A total of 46 incisions were randomized at the time of closure. Of these incisions 24 were randomized to Dermabond closure (TA) and 22 were randomized to subcuticular closure (SC). Performance measures included: time for closure, wound complications, and cosmesis. Cosmesis was evaluated by blinded evaluation of photographs of the incisions taken 4 weeks after surgery. Closure times for the TA group were faster than in the SC group (mean of 155 vs 286 seconds; P
In vitro assessment of microbial barrier properties of Dermabond topical skin adhesive. [2022]Several different techniques are used for wound closure. Cyanoacrylate tissue adhesives are less invasive and easy to apply, and the cosmetic results are comparable to or better than the conventional methods for wound repair. The purpose of this study is to demonstrate that Dermabond Topical Skin Adhesive, 2-octylcyanoacrylate (a registered trademark of Ethicon) is an effective barrier against the penetration of microorganisms in an in vitro model.
Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. [2016]2-Octyl cyanoacrylate (2-OCA; Dermabond) is a synthetic tissue adhesive that has proven utility in the closure of minor surgical incisions. Recently, we began using this adhesive for skin closure after circumcision and herein report our experience.
Octyl-2-cyanoacrylate as a routine dressing after open pediatric urological procedures. [2019]Octyl-2-cyanoacrylate Dermabond, Ethicon, Inc., Sommerville, New Jersey is a synthetic tissue adhesive that has recently been used for skin closure in the treatment of minor lacerations. We assess its effectiveness as a sole dressing after open pediatric urological procedures.
Dermabond skin closures for bilateral reduction mammaplasties: a review of 255 consecutive cases. [2021]2-Octyl cyanoacrylate (Dermabond; Ethicon, Inc., Somerville, N.J.) has been available as a skin closure alternative or adjunct since 1997. The purpose of this study was to review a large series of 255 consecutive bilateral reduction mammaplasty patients to evaluate the safety and efficacy of Dermabond for these procedures.
Type IV Hypersensitivity Reaction to Dermabond (2-Octyl Cyanoacrylate) in Plastic Surgical Patients: A Retrospective Study. [2023]Background: The Dermabond (2-octyl cyanoacrylate) is a commonly used skin adhesive in plastic surgery. There are some reports in the literature regarding Dermabond associated contact dermatitis. In this retrospective cohort study, we evaluated the incidence and characteristics of contact dermatitis (type IV hypersensitivity reaction) post application of Dermabond (Trade name PRINEO manufactured by ETHICON) in patients who underwent plastic surgical breast procedures in our hospital. Methods: Sixty patients had undergone plastic surgical breast procedures (mastopexy and reduction mammoplasty) with Dermabond application over the period of last 3 years in our hospital. The records of these 60 patients were studied retrospectively. Results: Four patients (6.6%) out of the 60 patients taken for study had developed type IV hypersensitivity reaction to Dermabond. All of these patients presented with pruritus and skin rash in the second week of their post-operative period and none of them had any known past allergic history. Conclusion: We conclude that the incidence of type IV hypersensitivity allergic reaction post application of Dermabond (2-octyl cyanoacrylate) is significantly high and its possibility should be explained to the patients prior to its application.
Diffuse cutaneous allergic reaction to Dermabond. [2022]Wound closure with 2-octyl cyanoacrylate (Dermabond; Ethicon, Somerville, New Jersey USA) has recently increased in popularity across a wide spectrum of physicians ranging from surgeons to emergency medicine practitioners. Generally, very few complications are associated with Dermabond and are usually related to application techniques. Uncommonly, patients present with allergic reactions to the adhesive compounds; these allergies are often misdiagnosed as cellulitis or another infectious process, and are incorrectly treated. This report describes a rare case of a diffuse cutaneous allergic reaction to Dermabond following its use to close a surgical incision, its prompt identification, and treatment after presentation to an emergency department.
Octylcyanoacrylate tissue adhesive versus suture wound repair in a contaminated wound model. [2019]Octylcyanoacrylate tissue adhesive is a topical wound closure that precludes the need for foreign bodies (sutures) to close wounds. It also has an in vitro antimicrobial effect when standard disc sensitivity tests are used.
Octylcyanoacrylate skin closure in laparoscopy. [2022]Octylcyanoacrylate (Dermabond) is a dermal bond useful in closing surgical skin incisions. We compared skin octylcyanoacrylate with subcuticular skin sutures to close laparoscopic trocar sites.