Last reviewed · How we verify
Closed Incision Negative Pressure Therapy vs Standard of Care
NA trial testing Prevena in Wound Complication in 122 participants. Completed in 7 March 2022.
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 122 |
| Start date | 14 May 2018 |
| Primary completion | 7 March 2022 |
| Estimated completion | 7 March 2022 |
| Sites | 3 locations across Canada, United States |
Columbia University
18 and older, any sex, with Wound Complication. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Occurrence of wound complications (wound drainage, breakdown, necrosis, dehiscence, superficial or deep infection) requiring additional intervention. Intervention will be defined as any attempt of the surgeon to improve wound healing (in-office debridement, topical ointment, aspiration, antibiotic therapy, or return to the OR for the wound).
| Group | Value | 95% CI |
|---|---|---|
| Prevena | 5 | |
| Aquacel | 11 |
Number of patients who met CDC criteria for superficial surgical site infection (SSI).
| Group | Value | 95% CI |
|---|---|---|
| Prevena | 2 | |
| Aquacel | 9 |
Time frame: 90 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Prevena | Aquacel |
|---|---|---|---|
| Acute periprosthetic joint infection | Surgical and medical procedures | — | — |
| Reaction | System | Prevena | Aquacel |
|---|---|---|---|
| Surgical site complications | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Acute periprosthetic joint infection.
Data from ClinicalTrials.gov NCT03061903 adverse events section.
High risk patients who receive direct anterior approach total hip arthroplasty are more likely to experience wound complications. The purpose of this study is to determine whether the usage of closed incision negative pressure dressings decreases the risk of wound complication compared to standard dressings. Patients who decide to participate in the study will be randomized to one of the two dressing prior to surgery and will leave the operating room with one of the treating dressings. Patient will be monitored 90 days after surgery for wound complications and pictures of the wounds will be taken. The patients course of treatment besides being randomized to one of the two dressings will be identical to any other patient received a Direct Anterior Approach for Total Hip Arthroplasty (DAA THA). The primary outcome measure will be uneventful wound healing (requiring no intervention) versus the occurrence of wound complications (wound drainage, breakdown, necrosis, dehiscence, superficial or deep infection) requiring additional intervention. Intervention will be defined as any attempt of the surgeon to improve wound healing (in-office debridement, topical ointment, aspiration, antibiotic therapy, or return to the OR for the wound). Secondary outcome measures will include duration of wound healing delay, length of hospital stay, number of days of antibiotic therapy, and direct and estimated indirect costs.
4 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03061903.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing