Closed Incision Negative Pressure Therapy vs Standard of Care
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | May 14, 2018 |
| End Date: | January 2020 |
| Contact: | Matthew S Heller |
| Email: | mh3818@cumc.columbia.edu |
| Phone: | 212-305-8193 |
Closed Incision Negative Pressure Therapy vs. Standard of Care for Surgical Incision Management in High-Risk Patients Following Total Hip Arthroplasty: A Randomized Controlled Trial
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.
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.
The goal of this study is to determine the efficacy of closed incision negative pressure
therapy (CiNPT) for prevention of wound complications and return to the operating room for
wound complications in patients with pre-determined risk factors that affect wound healing.
This is will be a prospective, randomized, controlled trial. Subjects will be randomly
assigned to either the ciNPT intervention group or the control group using
computer-generated, randomized envelopes with equal numbers in each treatment arm. Both
dressings will be applied under sterile conditions at the end of the DAA THA surgery, while
still in the operating room, and then removed after 7 days.
Patients randomized to the control group will receive a conformable, water resistant,
silver-impregnated, antimicrobial hydrofiber dressing (AQUACEL® Ag, Convatec) which is
currently the standard of care at our institution for postoperative wound dressing. This
dressing is left in place for 7 days and then removed by the patient or visiting nurse at
home. Patients randomized to the study group will receive an incisional ciNPT device, which
is currently being used selectively in high-risk patients at our institution (Prevena™, KCI).
Both wound dressings are FDA-approved devices. Due to the obvious difference in appearance of
the two dressings, neither patients nor treating surgeons can be blinded to treatment arm.
Wounds will be assessed postoperatively at regular intervals until wound healing is achieved.
This will occur at least 2 and 6 weeks after surgery, which are standard intervals in our
current postoperative protocol. No additional office visits will be needed for patients in
the control or treatment arms. Photodocumentation of the wounds will occur at two and six
weeks postoperatively.
therapy (CiNPT) for prevention of wound complications and return to the operating room for
wound complications in patients with pre-determined risk factors that affect wound healing.
This is will be a prospective, randomized, controlled trial. Subjects will be randomly
assigned to either the ciNPT intervention group or the control group using
computer-generated, randomized envelopes with equal numbers in each treatment arm. Both
dressings will be applied under sterile conditions at the end of the DAA THA surgery, while
still in the operating room, and then removed after 7 days.
Patients randomized to the control group will receive a conformable, water resistant,
silver-impregnated, antimicrobial hydrofiber dressing (AQUACEL® Ag, Convatec) which is
currently the standard of care at our institution for postoperative wound dressing. This
dressing is left in place for 7 days and then removed by the patient or visiting nurse at
home. Patients randomized to the study group will receive an incisional ciNPT device, which
is currently being used selectively in high-risk patients at our institution (Prevena™, KCI).
Both wound dressings are FDA-approved devices. Due to the obvious difference in appearance of
the two dressings, neither patients nor treating surgeons can be blinded to treatment arm.
Wounds will be assessed postoperatively at regular intervals until wound healing is achieved.
This will occur at least 2 and 6 weeks after surgery, which are standard intervals in our
current postoperative protocol. No additional office visits will be needed for patients in
the control or treatment arms. Photodocumentation of the wounds will occur at two and six
weeks postoperatively.
Inclusion Criteria:
1. Patients undergoing primary total hip arthroplasty (THA) through a direct anterior
approach by one of the investigating surgeons; and
2. The presence of one or more of these risk factors for delayed or problematic wound
healing:
1. Diabetes
2. Obesity (Body Mass Index (BMI) > 30)
3. Active smoking
4. Previous Hip Surgery
Exclusion Criteria:
1. Patients undergoing primary THA through a different approach
2. Patients undergoing primary THA through a direct anterior approach but without any of
the above risk factors
We found this trial at
3
sites
1235 Wilson Avenue
Toronto, Ontario M3M 0B2
Toronto, Ontario M3M 0B2
Principal Investigator: Sebastian Rodriguez-Elizalde, MD
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535 E 70th St
New York, New York 10021
New York, New York 10021
(212) 606-1000
Principal Investigator: Jose Rodriguez, MD
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Roshan P Shah, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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