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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of surgical glue to close small cuts made during abdominal surgeries. It compares Dermabond (2-octyl cyanoacrylate) and Swiftset (N-butyl-2-cyanoacrylate) to determine which more effectively keeps incisions closed and promotes healing. The trial seeks participants planning to undergo laparoscopic or robotic abdominal surgery who do not have allergies to the substances being tested. Participants will help researchers identify the best adhesive for closing surgical ports. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to significant advancements in surgical care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both 2-Octylcyanoacrylate and N-butyl-2-cyanoacrylate are generally safe and effective for closing surgical cuts.

For 2-Octylcyanoacrylate, studies have found it to be a safe choice for closing skin, with no major difference in infection rates compared to other methods. However, some people might experience allergic reactions like swelling and itching, usually about 10 days after use.

N-butyl-2-cyanoacrylate is also considered safe for small surgical cuts, with few complications. In some cases, the wound may open slightly, but it usually heals without further problems.

Overall, both adhesives effectively and safely close surgical sites, with minor risks of skin irritation or allergic reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for surgical port closure because they use advanced tissue adhesives that promise faster and more reliable wound sealing compared to traditional sutures and staples. Unlike other options, these adhesives, such as Dermabond and Swiftset, utilize cyanoacrylate compounds that form a strong bond over incisions, potentially reducing healing time and minimizing infection risks. This not only streamlines post-surgical care but also enhances patient comfort and outcomes.

What evidence suggests that this trial's methods of surgical port closure could be effective?

This trial will compare the effectiveness of two tissue adhesives for surgical port closure: 2-octylcyanoacrylate, commonly known as Dermabond, and Swiftset. Research has shown that 2-octylcyanoacrylate effectively closes surgical incisions, preventing bacteria from entering the skin 99% of the time for up to 72 hours. This adhesive works quickly and is more cost-effective than traditional stitches.

Meanwhile, studies on n-butyl-2-cyanoacrylate, another adhesive under investigation, found it caused fewer wound problems compared to stitches, with only 2.9% of cases experiencing issues. Participants were generally very satisfied with their scars, giving it an average score of 4.73 out of 5. It also closes wounds faster than both stitches and octyl cyanoacrylate. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11340837/

Comparative Evaluation of the Aesthetic Outcomes of Octyl ... Based on this study, the authors found that octyl-2-cyanoacrylate (Dermabond) and Ethilon suture were equally effective in terms of maintaining ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3015510/

Octylcyanoacrylate Skin Closure in Laparoscopy - PMC Laparoscopic port-site skin closure with octylcyanoacrylate is rapid and effective. Closure with octylcyanoacrylate yields cost savings and a decrease in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044316304444

Randomized Controlled Trial of Octyl Cyanoacrylate Skin ... To compare early outcomes of skin closure with octyl cyanoacrylate skin adhesive versus subcuticular suture closure.

4. withpower.com withpower.com/trial/phase-3-dermatitis-5-2022-8e15d

Tissue Adhesives for Surgical Port Closure In an in vitro study, Dermabond Topical Skin Adhesive (2-octylcyanoacrylate) demonstrated a 99% efficacy in preventing microbial penetration for up to 72 hours, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667008923000368

Skin adhesives versus absorbable sutures for closure of ... We conclude that wound complications, cosmetic outcome, and patient satisfaction were comparable between TSIs closed with tissue adhesives or sutures.

6. researchgate.net researchgate.net/publication/42640115_Prospective_randomized_study_to_evaluate_the_use_of_DERMABOND_ProPen_2-octlcyaboacrylate_in_the_closure_of_abdominal_wounds_versus_closure_with_skin_staples_in_patients_undergoing_elective_colectomy

Prospective randomized study to evaluate the use of ... There was no statistical difference in rates of wound infection. 2-OCA is a safe and effective means of skin closure in patients undergoing ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960052b.pdf

DERMABOND (a formulation of 2-octyl cyanoacrylate) Description: A prospective, randomized, controlled, unmasked study was conducted to evaluate the safety and effectiveness of closing the approximated skin edges ...

8. liebertpub.com liebertpub.com/doi/full/10.1089/derm.2023.0342?doi=10.1089/derm.2023.0342

Allergic Contact Dermatitis to Octyl Cyanoacrylate Skin ... Symptoms typically arise after 10 days post adhesive application, including swelling, rash, vesicles, erythema, and itching. Prior exposure to 2- ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960052c.pdf

DERMABOND* - Topical Skin Adhesive (2 Octyl ... Description: A prospective, randomized, controlled, unmasked study was conducted to evaluate the safety and effectiveness of closing the approximated skin edges ...