Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05844943 |
| Other study ID # |
STUDY00017024 |
| Secondary ID |
UL1TR002319 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 30, 2024 |
| Est. completion date |
June 1, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
University of Washington |
| Contact |
Karen Adams |
| Phone |
206 354 3360 |
| Email |
knadams1[@]uw.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Single-center nonrandomized single-arm early feasibility study of participants with soft
tissue trauma in the hand. Prior to enrolling participants with hand injuries, the safety of
continuous glove use for up to 96 hours without a glove replacement will be assessed on
healthy volunteers.
Injured participants will be on study for up to 7 weeks depending on when the final glove is
removed.
Screening: Prior to surgery and through 72 hours post-surgery to identify eligible patients
Treatment with Glove: Treatment begins with initial application of the ReHeal Glove and can
last up to 7 days (with dressing changes every 48-72 hours unless more frequent changes are
requested by the treating physician.)
Follow-up: Up to 6 weeks after final removal of glove to ensure complete wound healing.
Description:
A maximum of 10 participants may be enrolled. Each participants will be enrolled
sequentially, with in-depth review of study data from each individual participant before
proceeding to the next participant. There will be one and only one participant at a time
experiencing glove use. This allows the study team to identify and correct any safety issues
before another participant is enrolled and begins glove use. This strategy is in place to
minimize risk to participants. Screening data will be reviewed to determine participant
eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria
will be entered into the study.
Each participant will have the glove applied after surgery. The timing of the initial
application could be immediately following surgery or up to 3 days after the surgery, at the
discretion of the treating surgeon. Application delays of 1-3 days may be indicated if, in
the opinion of the surgeon, the wound would benefit from a period of immobilization prior to
donning the glove and allowing for the additional mobility possible with the glove dressing.
Reasons for a potential delay could include minimizing bleeding or oozing after debridement,
or for protection of a skin graft. Following current standards of negative pressure wound
therapy (NPWT), the wound will be assessed and the glove replaced every 48 to 72 hours. The
glove may be assessed by the clinical care team and, if needed, removed and replaced earlier.
At each participant encounter, data will be collected by the study team and pressure settings
will be documented. At each study visit involving a dressing change, the glove will be
removed for closer assessment of the wound and replaced with a new glove. Participants will
remain in the study until wound healing or clinical resolution, or study exit. After study
exit for each participant, data will be reviewed, and any design changes indicated by the
results of the study will be implemented prior to enrollment of the next subject.
The ReHeal Glove and Cardinal Health Negative Pressure Wound Therapy Pro/Pro To Go pump will
be used.
