Wound Complication Clinical Trial
— PrevenaOfficial title:
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
NCT number | NCT03061903 |
Other study ID # | AAAR5849 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 14, 2018 |
Est. completion date | March 7, 2022 |
Verified date | March 2023 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 122 |
Est. completion date | March 7, 2022 |
Est. primary completion date | March 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Humber River Hospital | Toronto | Ontario |
United States | Columbia University Medical Center | New York | New York |
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Kinetic Concepts, Inc. |
United States, Canada,
Christensen CP, Karthikeyan T, Jacobs CA. Greater prevalence of wound complications requiring reoperation with direct anterior approach total hip arthroplasty. J Arthroplasty. 2014 Sep;29(9):1839-41. doi: 10.1016/j.arth.2014.04.036. Epub 2014 May 2. — View Citation
Cooper HJ, Bas MA. Closed-Incision Negative-Pressure Therapy Versus Antimicrobial Dressings After Revision Hip and Knee Surgery: A Comparative Study. J Arthroplasty. 2016 May;31(5):1047-52. doi: 10.1016/j.arth.2015.11.010. Epub 2015 Nov 26. — View Citation
Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27. — View Citation
Jahng KH, Bas MA, Rodriguez JA, Cooper HJ. Risk Factors for Wound Complications After Direct Anterior Approach Hip Arthroplasty. J Arthroplasty. 2016 Nov;31(11):2583-2587. doi: 10.1016/j.arth.2016.04.030. Epub 2016 May 6. — View Citation
Jewett BA, Collis DK. High complication rate with anterior total hip arthroplasties on a fracture table. Clin Orthop Relat Res. 2011 Feb;469(2):503-7. doi: 10.1007/s11999-010-1568-1. — View Citation
Karlakki S, Brem M, Giannini S, Khanduja V, Stannard J, Martin R. Negative pressure wound therapy for managementof the surgical incision in orthopaedic surgery: A review of evidence and mechanisms for an emerging indication. Bone Joint Res. 2013 Dec 18;2(12):276-84. doi: 10.1302/2046-3758.212.2000190. Print 2013. — View Citation
Peel TN, Dowsey MM, Daffy JR, Stanley PA, Choong PF, Buising KL. Risk factors for prosthetic hip and knee infections according to arthroplasty site. J Hosp Infect. 2011 Oct;79(2):129-33. doi: 10.1016/j.jhin.2011.06.001. Epub 2011 Aug 6. — View Citation
Pulido L, Ghanem E, Joshi A, Purtill JJ, Parvizi J. Periprosthetic joint infection: the incidence, timing, and predisposing factors. Clin Orthop Relat Res. 2008 Jul;466(7):1710-5. doi: 10.1007/s11999-008-0209-4. Epub 2008 Apr 18. — View Citation
Rasouli MR, Restrepo C, Maltenfort MG, Purtill JJ, Parvizi J. Risk factors for surgical site infection following total joint arthroplasty. J Bone Joint Surg Am. 2014 Sep 17;96(18):e158. doi: 10.2106/JBJS.M.01363. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of Wound Complications | 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). | Up to 90 days | |
Secondary | Number of Patients With Superficial Surgical Site Infections | Number of patients who met CDC criteria for superficial surgical site infection (SSI). | 90 days |
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