Closed Incision Negative Pressure Therapy vs Standard of Care

NCT03061903 | Completed Results DMC FDA Device

• 1 other identifier: AAAR5849
• Study Type: interventional
• Target: 122
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Wound Complication

Keywords

total hip arthroplasty; direct anterior approach; wound complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Patients With Superficial Surgical Site Infections

  90 days

Study Arms (2)

Prevena

EXPERIMENTAL

Subjects will receive PREVENA after surgery.

Device: Prevena

Aquacel

ACTIVE COMPARATOR

Subjects will receive AQUACEL Ag after surgery.

Device: Aquacel

Interventions

Prevena DEVICE

Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days. Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device.

Also known as: Closed incision negative pressure therapy, ciNPT

Prevena

Aquacel DEVICE

Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days. AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device.

Also known as: Aquacel Ag

Aquacel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary total hip arthroplasty (THA) through a direct anterior approach by one of the investigating surgeons; and
• The presence of one or more of these risk factors for delayed or problematic wound healing:
• Diabetes
• Obesity (Body Mass Index (BMI) \> 30)
• Active smoking
• Previous Hip Surgery

You may not qualify if:

• Patients undergoing primary THA through a different approach
• Patients undergoing primary THA through a direct anterior approach but without any of the above risk factors

Sponsors & Collaborators

• Columbia University: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (3)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10023, United States

Location

Humber River Hospital

Toronto, Ontario, M3M 0B2, Canada

Location

Related Publications (9)

• 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.

  PMID: 20886324 BACKGROUND

• 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.

  PMID: 24890998 BACKGROUND

• 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.

  PMID: 27267230 BACKGROUND

• 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.

  PMID: 18421542 BACKGROUND

• 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.

  PMID: 21821313 BACKGROUND

• 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.

  PMID: 25232088 BACKGROUND

• 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.

  PMID: 24352756 BACKGROUND

• 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.

  PMID: 26712346 BACKGROUND

• 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.

  PMID: 23111014 BACKGROUND

Results Point of Contact

• Title: Roshan P. Shah, MD
• Organization: Columbia University

rs3464@cumc.columbia.edu

212-305-8193

Study Officials

• Roshan P Shah, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery at the Columbia Univer, Dept of Orthopaedic Surgery

Model Details: Subjects will be randomly assigned to either the ciNPT intervention group (Prevena) or the control group (Aquacel) 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 THA surgery, while still in the operating room, and then removed after 7 days.

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 23, 2017
• Study Start: May 14, 2018
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: April 11, 2023
• Results First Posted: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)