An interventional study of Surgical Control and Unicirc with tissue adhesive in Circumcision, sponsored by Simunye Primary Health Care. Completed at 1 site in South Africa. Open to male participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Simunye Primary Health Care · Not applicable, Interventional, and Treatment
This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.
Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision.
According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."
This quasi-experimental compares the open surgical technique to an alternative minimally-invasive technique using the disposable Unicirc device with tissue adhesive. The controls come from a separate randomized controlled trial (Unicirc 001) that was conducted just prior to the Unicirc 002 case series of 50 subjects. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.
Simunye Primary Health Care is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy men at least 18 years of age requesting circumcision
No anatomical penile abnormalities or infections
Able to provide informed consent to participate
Willing to participate in follow-up visits -
Exclusion Criteria:
Current illness
Penile abnormality or infection which contraindicates or would complicate circumcision
History of bleeding disorder
Past reaction to local anesthetic
-
Excision of foreskin with Unicirc device and sealing wound with tissue adhesive
Procedure: Unicirc with tissue adhesive
Surgical circumcision using forceps guided, dorsal slit, or sleeve method
Procedure: Surgical Control
The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
Intraoperative Duration
The number of minutes required to perform the surgical procedure
Time frame: 1 hour
Number of Participants With Adverse Events
Bleeding, hematoma, infection and other rare adverse events
Time frame: 1 month
Blood Loss
Number of ml of blood lost during the procedure, as assessed by the surgeon
Time frame: During procedure (up to 1 hour)
Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks
The number of participants with complete epithelialization (completely healed) at 4 weeks
Time frame: 1 month
Cosmetic Result
Regular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
Time frame: 6 weeks
| Milestone | Unicirc With Tissue Adhesive | Surgical Control |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
The number of minutes required to perform the surgical procedure
| Min | Unicirc With Tissue Adhesive | Surgical Control |
|---|---|---|
| Intraoperative Duration | 9.0 (8.5 to 10.0) | 22.6 (18.4 to 27.0) |
Bleeding, hematoma, infection and other rare adverse events
| participants | Unicirc With Tissue Adhesive | Surgical Control |
|---|---|---|
| Number of Participants With Adverse Events | 4 | 9 |
Number of ml of blood lost during the procedure, as assessed by the surgeon
| ml | Unicirc With Tissue Adhesive | Surgical Control |
|---|---|---|
| Blood Loss | 1.5 (1.5 to 1.5) | 5.5 (5.5 to 12) |
The number of participants with complete epithelialization (completely healed) at 4 weeks
| participants | Unicirc With Tissue Adhesive | Surgical Control |
|---|---|---|
| Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks | 49 | 49 |
Regular: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
| participants | Unicirc With Tissue Adhesive | Surgical Control |
|---|---|---|
| Regular | 50 | 20 |
| Irregular | 0 | 8 |
| Scalloped | 0 | 22 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unicirc With Tissue Adhesive | — | 0/50 (0%) | 4/50 (8%) |
| Surgical Control | — | 0/50 (0%) | 9/50 (18%) |
| Event | Unicirc With Tissue Adhesive | Surgical Control |
|---|---|---|
| Post-op infectionInfections and infestations | 2/50 | 6/50 |
| Post-op bleeding or hematomaBlood and lymphatic system disorders | 2/50 | 3/50 |
| Age, Categorical(Participants) | Unicirc With Tissue Adhesive | Surgical Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 50 | 100 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Unicirc With Tissue Adhesive | Surgical Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 50 | 50 | 100 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Simunye Primary Health Care