An interventional study of PrevenaTM Device and Standard Dry Dressing in Surgical Wound, Wound Heal and Amputation, sponsored by Georgetown University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Georgetown University · 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 26th largest by planned enrollment of the 111 interventional ones that give a count, is one of 10 that started in 2017, is one of 88 with no phase, and was the 46th 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 · healthy volunteers too.
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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. 10 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 112 is above 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:
Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Georgetown University 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.
The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.
Incisional negative pressure wound therapy is an approved device used for wound healing of closed surgical incisions. This research is being done because incisional negative pressure wound therapy is a new application of negative pressure wound therapy that is applied over a closed incision area instead of an open wound. Negative pressure wound therapy is commonly used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and a battery-powered device that places negative pressure on the wound. Currently, there are no trials utilizing incisional negative pressure wound therapy of closed wounds after below knee amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure wound therapy and standard dressings in patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.
Other: Standard Dry Dressing
This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.
Device: PrevenaTM Device
The PrevenaTM Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.
These are customary dry dressings.
Proportion of postoperative incision complications between the 2 arms
The proportion of issues that arise between the two groups after closure surgery.
Time frame: 95 days
Length of hospital stay
The amount of time the patients must stay after closure surgery.
Time frame: 5 days
Number of surgically related wound readmissions
The number of times patients are readmitted to the hospital for their surgical wound post-discharge.
Time frame: 95 days
Medical Outcomes Study 12 Short Form Health Survey (SF-12)
Change in quality of life from the start of the study to the end.
Time frame: 95 days
Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge
The percentage of closed surgical wounds that remain closed after 1, 2 and 3 months after their closure surgery.
Time frame: At 1, 2, and 3 months post-hospital discharge
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Sep 2020, 34 months after the start.
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 planned 34 months is above 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 status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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