Trials / Unknown
UnknownNCT03628690
A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- BandGrip · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture
Detailed description
Up to 45 subjects at up to 2 study sites who present to the ER for treatment of a skin laceration will be consented and randomized to treatment with suture or BandGrip. Subjects will be followed for 30 days post treatment to assess cosmetic quality of wound healing, evidence of adverse events related to closure method, and speed and completeness of wound closure and removal of closure devices.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BandGrip | Topical skin closure device |
| DEVICE | Suture | Wound closure |
Timeline
- Start date
- 2018-07-15
- Primary completion
- 2019-12-01
- Completion
- 2020-02-01
- First posted
- 2018-08-14
- Last updated
- 2019-07-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03628690. Inclusion in this directory is not an endorsement.