Tissue Adhesives for Surgical Port Closure

Overseen By Julie Holihan

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Allergy to cyanoacrylate, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

184 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{1 3 4 9 10}

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.

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.

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 Overview 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.

Participant Groups

Group I: Dermabond Active Control 2 Interventions

Dermabond over incisions

Group II: Swiftset Active Control 2 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro assessment of microbial barrier properties of Dermabond topical skin adhesive. Bhende, S., Rothenburger, S., Spangler, DJ., et al.[2022]

In a study of 267 patients undergoing circumcision or circumcision revision, the use of 2-Octyl cyanoacrylate (2-OCA) for skin closure resulted in a significantly faster closure time, averaging 3 minutes initially and improving to less than 90 seconds with experience.

The cosmetic outcomes with 2-OCA were reported to be better than traditional sutures, with fewer complications and high parental satisfaction, making it a preferred method for circumcision closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. Elmore, JM., Smith, EA., Kirsch, AJ.[2016]

In a study of 146 pediatric patients undergoing urological procedures, the use of Octyl-2-cyanoacrylate Dermabond as the sole dressing resulted in only one complication, indicating its effectiveness for skin closure.

The study found that allowing early bathing and return to activity did not negatively affect wound healing, suggesting that Dermabond can safely replace traditional dressings in pediatric surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octyl-2-cyanoacrylate as a routine dressing after open pediatric urological procedures. Rajimwale, A., Golden, BK., Oottomasathien, S., et al.[2019]

In a study of 255 patients undergoing bilateral reduction mammaplasty, the use of Dermabond for skin closure resulted in significantly shorter operative times (93 minutes) compared to traditional sutured closures (118 minutes), saving about 25 minutes per procedure.

The use of Dermabond was associated with lower rates of minor and major wound complications, as well as hypertrophic scars and cellulitis, suggesting it is a safe and effective alternative for skin closure in these surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermabond skin closures for bilateral reduction mammaplasties: a review of 255 consecutive cases. Scott, GR., Carson, CL., Borah, GL.[2021]

In a study of 60 patients who underwent plastic surgical breast procedures using Dermabond, 6.6% developed type IV hypersensitivity reactions, characterized by pruritus and skin rash occurring in the second week post-operation.

The findings suggest that the incidence of allergic reactions to Dermabond is significant enough that patients should be informed about this risk before its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type IV Hypersensitivity Reaction to Dermabond (2-Octyl Cyanoacrylate) in Plastic Surgical Patients: A Retrospective Study. Alotaibi, NN., Ahmad, T., Rabah, SM., et al.[2023]

Dermabond (2-octyl cyanoacrylate) is increasingly used for wound closure with minimal complications, primarily related to application techniques.

A rare case of an allergic reaction to Dermabond was identified, highlighting the importance of recognizing such reactions to avoid misdiagnosis and inappropriate treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffuse cutaneous allergic reaction to Dermabond. Ricci, JA., Parekh, NN., Desai, NS.[2022]

In a study involving 20 guinea pigs, wounds closed with octylcyanoacrylate tissue adhesive showed a significantly lower infection rate compared to those closed with sutures, with 0% infection in the adhesive group versus 55% in the suture group.

The results suggest that octylcyanoacrylate not only effectively closes contaminated wounds but also may reduce the risk of infection, indicating its potential as a safer alternative to traditional sutures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octylcyanoacrylate tissue adhesive versus suture wound repair in a contaminated wound model. Quinn, J., Maw, J., Ramotar, K., et al.[2019]

Using octylcyanoacrylate (Dermabond) for closing laparoscopic trocar sites is significantly faster, averaging 3.7 minutes compared to 14 minutes for subcuticular sutures, which can improve surgical efficiency.

Both methods showed similar rates of wound complications, but octylcyanoacrylate resulted in substantial cost savings, averaging $198 per closure compared to $497 for sutures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octylcyanoacrylate skin closure in laparoscopy. Sebesta, MJ., Bishoff, JT.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Octylcyanoacrylate skin closure in laparoscopy. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Subcuticular closure versus Dermabond: a prospective randomized trial. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

In vitro assessment of microbial barrier properties of Dermabond topical skin adhesive. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Octyl-2-cyanoacrylate as a routine dressing after open pediatric urological procedures. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Dermabond skin closures for bilateral reduction mammaplasties: a review of 255 consecutive cases. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Type IV Hypersensitivity Reaction to Dermabond (2-Octyl Cyanoacrylate) in Plastic Surgical Patients: A Retrospective Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Diffuse cutaneous allergic reaction to Dermabond. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Octylcyanoacrylate tissue adhesive versus suture wound repair in a contaminated wound model. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Octylcyanoacrylate skin closure in laparoscopy. [2022]