Closed Incision Negative Pressure Therapy vs Standard of Care

NCT ID: NCT03061903

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-14
• Study Completion Date: 2022-03-07

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.

Detailed Description

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.

Conditions

Wound Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prevena

Subjects will receive PREVENA after surgery.

Group Type: EXPERIMENTAL

Prevena

Intervention Type: 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.

Aquacel

Subjects will receive AQUACEL Ag after surgery.

Group Type: ACTIVE_COMPARATOR

Aquacel

Intervention Type: 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.

Interventions

Prevena

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.

Intervention Type: DEVICE

Aquacel

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.

Intervention Type: DEVICE

Other Intervention Names

Closed incision negative pressure therapy; ciNPT; Aquacel Ag

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kinetic Concepts, Inc.

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Roshan P. Shah

Assistant Professor of Orthopedic Surgery at the Columbia Univer, Dept of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roshan P Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Hospital for Special Surgery

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Humber River Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 20886324 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24890998 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27267230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18421542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21821313 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25232088 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24352756 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26712346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23111014 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAR5849

Identifier Type: -

Identifier Source: org_study_id