Wound ComplicationPrevenaNCT03061903
Closed Incision Negative Pressure Therapy vs Standard of Care
A study testing Prevena and Aquacel in people with Wound Complication, run by Columbia University at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Complication
- What is being tested?
- Prevena and Aquacel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 May 2018to 7 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Hospital for Special Surgery
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10023
About this study
Official 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
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.
Read the 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
- Being tested
- Prevena, Aquacel
- Keywords
- total hip arthroplasty, direct anterior approach, wound complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevenaDevice
Also called Closed incision negative pressure therapy, ciNPT
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.
AquacelDevice
Also called Aquacel Ag
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.
| Study group | Role | What they receive |
|---|---|---|
| Prevena | Experimental | Subjects will receive PREVENA after surgery. Receives: Device: Prevena |
| Aquacel | Active comparator | Subjects will receive AQUACEL Ag after surgery. Receives: Device: Aquacel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 90 days
Secondary outcomes (1)
Number of Patients With Superficial Surgical Site Infections
Number of patients who met CDC criteria for superficial surgical site infection (SSI).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start14 May 2018
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Principal investigator, Roshan P. Shah, Columbia University
- Investigators
- Roshan P Shah, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061903
- Sponsor's protocol ID
- AAAR5849
- Acronym
- Prevena
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2017
- Last updated
- 11 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 20886324Christensen 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.
PubMed 24890998Jahng 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.
PubMed 27267230Pulido 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.
PubMed 18421542Peel 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.
PubMed 21821313Rasouli 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.
PubMed 25232088Karlakki 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.
PubMed 24352756Cooper 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.
PubMed 26712346Grauhan 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.
PubMed 23111014
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03061903
- Acronym / sponsor ID
- Prevena / AAAR5849
- Conditions
- Wound Complication
- Keywords
- total hip arthroplasty, direct anterior approach, wound complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- 14 May 2018 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 11 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prevena | Experimental | Device: PrevenaSubjects will receive PREVENA after surgery. |
| Aquacel | Active comparator | Device: AquacelSubjects will receive AQUACEL Ag after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrevenaAlso: Closed incision negative pressure therapy, ciNPTClosed 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. | Device | Prevena |
| AquacelAlso: Aquacel AgWater 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. | Device | Aquacel |
Primary outcome
Prevalence of Wound Complications
Time frame: Up to 90 days
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).
1 secondary outcome
Number of Patients With Superficial Surgical Site Infections
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20886324Jewett 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.
- Background: PubMed 24890998Christensen 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.
- Background: PubMed 27267230Jahng 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.
- Background: PubMed 18421542Pulido 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.
- Background: PubMed 21821313Peel 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.
- Background: PubMed 25232088Rasouli 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.
- Background: PubMed 24352756Karlakki 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.
- Background: PubMed 26712346Cooper 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.
- Background: PubMed 23111014Grauhan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshan P Shah, MD principal investigator
Columbia University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena and Aquacel in people with Wound Complication, run by Columbia University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Wound Complications (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061903, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.