Paraphimosis, Phimosis
Conditions
Brief summary
This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure. To the best of our knowledge, this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision. The findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure. Additionally, this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision.
Detailed description
This non-blinded, randomized controlled pilot study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients undergoing circumcision will be invited to participate in the study. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. Patients will be randomized to 2-Octyl cyanoacrylate (2-OCA) with four interrupted sutures vs. standard suturing alone. In the post-operative recovery area, patients will be asked to complete a VAS questionnaire. Patients will then be brought in for their routine visit 6 weeks post-op. During the visit, closure of the wound as well as any potential complications will be assessed by a research team member. At that time, a questionnaire will be administered to study participants to assess variables such as post-procedure pain as well as their satisfaction with the recovery process and cosmesis post-circumcision. Cosmesis and complications will also be assessed 12 weeks post-op.
Interventions
PROCEDURECircumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures
2-octyl cyanoacrylate glue is a wound closure adhesive which will be used with four interrupted sutures following circumcision for wound closure.
PROCEDURECircumcision wound closure using continuous sutuing
Continuous suturing is the standard following circumcision for wound closure.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
16 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients \>16 years of age undergoing circumcision will be included.
Exclusion criteria
* Patients \<16 years of age who did not provide consent to be randomized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | 6 and 12 weeks post-operation | Measuring and recording any adverse events post procedure such as surgical site infection, bleeding, hematoma, diffuse swelling, and increased sensitivity amidst intercourse. |
| Cosmesis | 6 and 12 weeks post-operation | A cosmetic appearance satisfaction questionnaire will be administered at weeks 6 and 12 post-operation. |
| Post-operative Pain | Immediately post-operation and 6 weeks post-operation | Using a visual analogue pain scale \[range 0-10; 0 = no pain, 10 = maximal pain\], pain will be assessed as reported by the patient to determine their pain. |
| Intra-Operative Time | During the operation | Intra-operative time will be measured starting when the physician makes the first incision and ends when sutures are finished. |
Countries
Canada
Outcome results
None listed