An interventional study of PICO Single Use Negative Pressure Wound Therapy System and xeroform gauze in Surgical Wound, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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Among 129 studies in Surgical Wound with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Surgical Wound · United States.
Among the 129 studies in Surgical Wound with a site in United States, this one is the 82nd largest by enrollment of the 111 interventional ones that give a count, is one of 12 that started in 2018, is one of 88 with no phase, and was the 50th registered.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
Browse Surgical Wound studies →17 of the 129 studies in Surgical Wound with a site in United States are open now. Recruiting first, the newest first:
The Metis Foundation · Sites in United States
Ages 18–85
Acera Surgical, Inc. · Sites in United States
Ages 18+
University of Nevada, Las Vegas · Sites in United States
Ages 18+ · Healthy volunteers
Hospital for Special Surgery, New York · Sites in United States
Ages 18+
Venus Concept · Sites in United States
Ages 21–75 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Surgical Wound studies recruiting now, 19 (58%) set no upper age limit and 10 (30%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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129 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 4 · Phase 4 11
First in 2004; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.
Median enrollment 50 across the 111 interventional studies, 46 across the 18 observational. Of the 87 that completed or were terminated, 43 (49%) have results posted.
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45 of 129 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 2 studies filed under Surgical Wound — fewer than ten, so there is no comparison to draw.
9 of the studies in Surgical Wound with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06259409Progenerative Medical, IncRegenn® Therapy System Safety Study | 2026-12 |
| NCT04718168W.L.Gore & AssociatesGORE® ENFORM Biomaterial Product Study | 2026-12 |
| NCT06014411Hospital for Special Surgery, New YorkEarly Versus Delayed Bathing of Orthopaedic Surgical Wounds | 2026-12 |
| NCT07653165West Boca Center for Wound HealingUse of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds | 2026-12-31 |
| NCT04786106Charitable Union for the Research and Education of Peyronie's DiseaseInvestigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's | 2027-02-15 |
Add all 9 to your calendar (.ics) → With an account.
Among the 129 studies in Surgical Wound with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Various management options for free flap donor sites that require split thickness skin grafting exist. None has proven superior from both a patient care and a cost standpoint. Major complications occurring at these surgical sites include wound breakdown, tendon exposure, and loss of function. We seek to investigate the use of the PICO single-use negative pressure wound therapy device in these surgical sites and determine if it can yield superior results to simpler methods.
Many studies have addressed the use of negative pressure wound therapy (NPWT) in free flap donor sites with mixed results. It is well established that NPWT is safe and causes no harm, and no delay in healing. A previous study performed at UAB showed that NPWT in complex Head \& Neck Surgery reconstruction is safe, including free flap donor sites. There have been studies that state the rate of tendon exposure is lower with NPWT in free flap donor sites, and studies that conclude there is no difference in complication rates. Current clinical practice is varied, often within a single institution.
While no studies of NPWT in free flap donor sites have noted inferior results with its use, a primary reason cited for not using it is cost. Traditional NPWT using canister-based vacuum devices adds significant cost. The PICO single-use NPWT device (Smith \& Nephew) is a relatively inexpensive, low-profile dressing that does not require attachment to an external canister. It is battery-powered and disposable. Empiric use on our patients undergoing split-thickness skin-grafting to free flap donor sites shows good results with minimal intra-operative effort compared to traditional bandaging. We would like to prospectively investigate the use of this low-cost NPWT device and compare it directly to the traditional post-op dressing method.
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Exclusion Criteria:
PICO Single Use Negative Pressure Wound Therapy System
Device: PICO Single Use Negative Pressure Wound Therapy System
traditional surgical wound dressing of xeroform gauze and padding
Device: xeroform gauze
Class II negative pressure wound therapy powered suction pump
traditional surgical dressing of xeroform gauze and padding
Progression of Wound Healing
Comparison of photographs of all participants' wounds taken at post-operative Day 5, post-operative Day 14-21, and post-operative Day 30. Percentage skin graft take will be evaluated on Day 30 by blinded, independent raters. A 10x10 grid was digitally overlain on each image. The de-identified images were randomized and given to two independent raters. The raters used three criteria to assess each graft. Overall graft appearance was graded on a 1-5 scale, percent of graft take was estimated, and the presence of exposed tendon was noted for each timepoint.
Time frame: Baseline through 30 days
| Milestone | Negative Pressure Wound Therapy | Conventional Dressing |
|---|---|---|
| Started | 11 | 9 |
| Completed | 9 | 7 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
Comparison of photographs of all participants' wounds taken at post-operative Day 5, post-operative Day 14-21, and post-operative Day 30. Percentage skin graft take will be evaluated on Day 30 by blinded, independent raters. A 10x10 grid was digitally overlain on each image. The de-identified images were randomized and given to two independent raters. The raters used three criteria to assess each graft. Overall graft appearance was graded on a 1-5 scale, percent of graft take was estimated, and the presence of exposed tendon was noted for each timepoint.
| percentage of skin graft take | Negative Pressure Wound Therapy | Conventional Dressing |
|---|---|---|
| Progression of Wound Healing | 69.9 (50 to 90) | 75.6 (55 to 95) |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Negative Pressure Wound Therapy | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Conventional Dressing | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Negative Pressure Wound Therapy | Conventional Dressing | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 5 | 11 |
| >=65 years | 5 | 4 | 9 |
| Sex: Female, Male(Participants) | Negative Pressure Wound Therapy | Conventional Dressing | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 7 | 8 | 15 |
| Race (NIH/OMB)(Participants) | Negative Pressure Wound Therapy | Conventional Dressing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 10 | 9 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Negative Pressure Wound Therapy | Conventional Dressing | Total |
|---|---|---|---|
| United States | 11 | 9 | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Apr 2020, 21 months.
Results were first posted in Jul 2021, 1 year 3 months after primary completion.
Of 99 non-industry interventional studies with no phase under Surgical Wound, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 53. This study's 21 months is below that.
Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →