Dermabond for Circumcision Complications

Overseen By Michael E Chua, MD

Age: < 18

Sex: Male

Trial Phase: Phase 3

Sponsor: The Hospital for Sick Children

Disqualifiers: Bleeding disorders, Genital anomalies, Allergies, 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: 6

Duration: Immediate post-procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of Dermabond, a special skin adhesive, in preventing complications after neonatal circumcision. Researchers compare it to a control group using Vaseline to determine if Dermabond reduces issues like bleeding or infection and improves the appearance and feel of the circumcision site to parents. The trial also assesses whether Dermabond affects pain during recovery. It is open to healthy baby boys undergoing circumcision who have no blood clotting problems or genital anomalies. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that 2-Octyl Cyanoacrylate, commonly known as Dermabond, is generally safe for circumcision procedures. One study found that this glue-like material can serve as a safe and appealing alternative to stitches for closing the circumcision site. In earlier research, the most common issues included mild swelling (10%) and slight separation of the wound edges (8.3%). However, most wounds healed well, with 91.7% showing complete skin repair.

Another study found no significant difference in scar tissue formation (adhesions) when using Dermabond compared to stitches in young boys. Overall, circumcision with Dermabond presents a relatively safe procedure with a low risk of serious problems. Most issues are minor and easy to manage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for post-circumcision complications, which often involves using Vaseline cream to aid healing, 2-octyl cyanoacrylate (Dermabond) offers a unique approach. Researchers are excited because Dermabond serves as a medical adhesive that creates a protective barrier over the wound, potentially reducing infection risk and promoting faster healing. Additionally, this treatment is applied as a topical liquid that quickly forms a strong, flexible film, which could enhance convenience and comfort compared to traditional ointments.

What evidence suggests that Dermabond might be an effective treatment for circumcision complications?

Research has shown that 2-Octyl Cyanoacrylate, commonly known as Dermabond, can aid in caring for the surgical area after a circumcision. In this trial, participants in the Dermabond group will receive a topical application of 2-Octyl Cyanoacrylate around the post-circumcision site. Studies have found that using Dermabond results in fewer complications and improved cosmetic outcomes. In one study, only 1.3% of cases experienced complications, a very low rate. Another study found that 91.7% of patients healed completely, with only minor issues such as mild swelling or slight wound separation. These findings suggest that Dermabond may help reduce complications and enhance healing after a newborn's circumcision. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for male newborns aged 2 to 60 days in good health, eligible for circumcision without genital anomalies or a family history of bleeding disorders. Babies with known allergies to Dermabond, clotting issues, recent febrile illness, or conditions that could affect study participation are excluded.

Inclusion Criteria

I am a male newborn eligible for circumcision without genital anomalies.

Consent provided by one of the parents

I do not have blood diseases like hemophilia.

Exclusion Criteria

Genital anomalies such as hypospadias, severe ventral curvatures

Known allergic reactions to components of the 2-Octyl Cyanoacrylate (Dermabond)

Family history of bleeding or clotting disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of 2-Octyl Cyanoacrylate (Dermabond) or Vaseline cream immediately after neonatal circumcision

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for complications, pain scores, and parents' satisfaction post-circumcision

180 days

Multiple assessments at 5 minutes, 30 minutes, 24 hours, 2 weeks, 30 days, and up to 180 days

What Are the Treatments Tested in This Trial?

Interventions

• 2-octyl cyanoacrylate

Trial Overview The trial tests the safety and effectiveness of using Dermabond (2-Octyl Cyanoacrylate) on the circumcision site in newborns. It compares babies treated with Dermabond to those who aren't, looking at complication rates and pain within six months post-procedure.

How Is the Trial Designed?

Group I: 2-Octyl Cyanoacrylate (Dermabond) Group Experimental Treatment 1 Intervention

2-Octyl Cyanoacrylate (Dermabond) 0.5ml/ sticks topical application around post-circumcision site subcoronal area immediately after the circumcision devise is removed and circumcision procedure was done

Group II: Control Group Active Control 1 Intervention

will receive Vaseline cream application around the post-circumcision site immediately after circumcision

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35466011/

Sutureless circumcision using monopolar diathermy and 2- ... Our technique for suture-less circumcision using 2-OCA offers superior cosmesis, shorter OR times, cost savings, and a lower complication rate (1.3%)

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06487494

Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA ... The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of ...

3. jneonatalsurg.com jneonatalsurg.com/index.php/jns/article/view/9171

Sutureless Neonatal Circumcision Using 2-Octyl ... Most common complications were mild edema (10.0%) and minor wound edge separation (8.3%). Complete epithelialization occurred in 91.7% of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429507018122

Sutureless Circumcision Using 2-Octyl Cyanoacrylate ... At a mean follow-up of 13 months (range 2 to 18), three postoperative complications had occurred. The cosmetic outcomes have been subjectively better than those ...

5. spuonline.org spuonline.org/fallcongress/program/2021/P9.cgi

SPU - NO INSTRUMENTS, NO SUTURES, NO WORRIES Post-neonatal, prepubescent sutured circumcision demonstrates complication rates ranging from 1.7% - 9.1%. We have previously reported that 2-octyl ...

6. fda.gov fda.gov/media/158488/download

Cyanoacrylates: Medical Device Material Safety Summary One RCT18 found no statistical difference in adhesions when using CA over sutures following circumcision in children less than. 7 years of age.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3253617/

Complications of Circumcision - PMC It is a relatively safe procedure with a low overall complication rate. Most complications are minor and can be managed easily.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04908137?term=AREA%5BInterventionSearch%5D(OCRILATE)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=1

Study Details | Use of 2-Octyl Cyanoacrylate (Dermabond) ... This is a single-centered, randomized clinical trial to assess the efficacy and safety of 2-Octyl Cyanoacrylate (Dermabond) application in neonatal circumcision ...