Closed Incision Negative Pressure Therapy vs. Standard of Care for Surgical Incision Management in High-Risk Patients Following Total Hip Arthroplasty: ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2018-2020

ABSTRACT

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. More... »

URL

https://clinicaltrials.gov/show/NCT03061903

Related SciGraph Publications

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/3053", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "type": "DefinedTerm"
      }
    ], 
    "description": "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.\n\nDetailed Description\nThe 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\u00ae 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\u2122, 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.", 
    "endDate": "2020-01-01T00:00:00Z", 
    "id": "sg:clinicaltrial.NCT03061903", 
    "keywords": [
      "incision", 
      "negative pressure", 
      "care", 
      "high-risk patient", 
      "total hip arthroplasty", 
      "randomized controlled trial", 
      "complication", 
      "usage", 
      "risk", 
      "patient", 
      "Bandage", 
      "General Surgery", 
      "room", 
      "picture", 
      "Wound and Injury", 
      "DAA", 
      "primary outcome measure", 
      "wound healing", 
      "intervention", 
      "occurrence", 
      "drainage", 
      "breakdown", 
      "necrosis", 
      "infection", 
      "additional intervention", 
      "surgeon", 
      "debridement", 
      "ointment", 
      "aspiration", 
      "antibiotic therapy", 
      "return", 
      "Secondary outcome measure", 
      "duration", 
      "hospital", 
      "indirect cost", 
      "efficacy", 
      "prevention", 
      "risk factor", 
      "intervention group", 
      "control group", 
      "envelope", 
      "equal number", 
      "treatment arm", 
      "sterile condition", 
      "water", 
      "antimicrobial", 
      "Ag", 
      "institution", 
      "wound dressing", 
      "nurse", 
      "home", 
      "study group", 
      "FDA", 
      "obvious difference", 
      "appearance", 
      "regular interval", 
      "interval", 
      "protocol", 
      "office visit", 
      "control"
    ], 
    "name": "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", 
    "sameAs": [
      "https://app.dimensions.ai/details/clinical_trial/NCT03061903"
    ], 
    "sdDataset": "clinical_trials", 
    "sdDatePublished": "2019-03-07T15:27", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "file:///pack/app/us_ct_data_00023.json", 
    "sponsor": [
      {
        "id": "https://www.grid.ac/institutes/grid.239915.5", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.417432.7", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.413632.1", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.21729.3f", 
        "type": "Organization"
      }, 
      {
        "id": "https://www.grid.ac/institutes/grid.239585.0", 
        "type": "Organization"
      }
    ], 
    "startDate": "2018-05-01T00:00:00Z", 
    "subjectOf": [
      {
        "id": "https://doi.org/10.1016/j.jhin.2011.06.001", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1000993891"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.arth.2016.04.030", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1005530488"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.jtcvs.2012.09.040", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1014629586"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s11999-008-0209-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1024742691", 
          "https://doi.org/10.1007/s11999-008-0209-4"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s11999-008-0209-4", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1024742691", 
          "https://doi.org/10.1007/s11999-008-0209-4"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1302/2046-3758.212.2000190", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040215919"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.arth.2014.04.036", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1042123078"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.1016/j.arth.2015.11.010", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1043238908"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/s11999-010-1568-1", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1046928682", 
          "https://doi.org/10.1007/s11999-010-1568-1"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "https://doi.org/10.2106/jbjs.m.01363", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1068903678"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "type": "MedicalStudy", 
    "url": "https://clinicaltrials.gov/show/NCT03061903"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/clinicaltrial.NCT03061903'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/clinicaltrial.NCT03061903'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/clinicaltrial.NCT03061903'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/clinicaltrial.NCT03061903'


 

This table displays all metadata directly associated to this object as RDF triples.

116 TRIPLES      16 PREDICATES      88 URIs      69 LITERALS      1 BLANK NODES

Subject Predicate Object
1 sg:clinicaltrial.NCT03061903 schema:about anzsrc-for:3053
2 schema:description 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.
3 schema:endDate 2020-01-01T00:00:00Z
4 schema:keywords Ag
5 Bandage
6 DAA
7 FDA
8 General Surgery
9 Secondary outcome measure
10 Wound and Injury
11 additional intervention
12 antibiotic therapy
13 antimicrobial
14 appearance
15 aspiration
16 breakdown
17 care
18 complication
19 control
20 control group
21 debridement
22 drainage
23 duration
24 efficacy
25 envelope
26 equal number
27 high-risk patient
28 home
29 hospital
30 incision
31 indirect cost
32 infection
33 institution
34 interval
35 intervention
36 intervention group
37 necrosis
38 negative pressure
39 nurse
40 obvious difference
41 occurrence
42 office visit
43 ointment
44 patient
45 picture
46 prevention
47 primary outcome measure
48 protocol
49 randomized controlled trial
50 regular interval
51 return
52 risk
53 risk factor
54 room
55 sterile condition
56 study group
57 surgeon
58 total hip arthroplasty
59 treatment arm
60 usage
61 water
62 wound dressing
63 wound healing
64 schema:name 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
65 schema:sameAs https://app.dimensions.ai/details/clinical_trial/NCT03061903
66 schema:sdDatePublished 2019-03-07T15:27
67 schema:sdLicense https://scigraph.springernature.com/explorer/license/
68 schema:sdPublisher N40cc7232993d463babc2b0ce307180df
69 schema:sponsor https://www.grid.ac/institutes/grid.21729.3f
70 https://www.grid.ac/institutes/grid.239585.0
71 https://www.grid.ac/institutes/grid.239915.5
72 https://www.grid.ac/institutes/grid.413632.1
73 https://www.grid.ac/institutes/grid.417432.7
74 schema:startDate 2018-05-01T00:00:00Z
75 schema:subjectOf sg:pub.10.1007/s11999-008-0209-4
76 sg:pub.10.1007/s11999-010-1568-1
77 https://doi.org/10.1016/j.arth.2014.04.036
78 https://doi.org/10.1016/j.arth.2015.11.010
79 https://doi.org/10.1016/j.arth.2016.04.030
80 https://doi.org/10.1016/j.jhin.2011.06.001
81 https://doi.org/10.1016/j.jtcvs.2012.09.040
82 https://doi.org/10.1302/2046-3758.212.2000190
83 https://doi.org/10.2106/jbjs.m.01363
84 schema:url https://clinicaltrials.gov/show/NCT03061903
85 sgo:license sg:explorer/license/
86 sgo:sdDataset clinical_trials
87 rdf:type schema:MedicalStudy
88 N40cc7232993d463babc2b0ce307180df schema:name Springer Nature - SN SciGraph project
89 rdf:type schema:Organization
90 anzsrc-for:3053 schema:inDefinedTermSet anzsrc-for:
91 rdf:type schema:DefinedTerm
92 sg:pub.10.1007/s11999-008-0209-4 schema:sameAs https://app.dimensions.ai/details/publication/pub.1024742691
93 https://doi.org/10.1007/s11999-008-0209-4
94 rdf:type schema:CreativeWork
95 sg:pub.10.1007/s11999-010-1568-1 schema:sameAs https://app.dimensions.ai/details/publication/pub.1046928682
96 https://doi.org/10.1007/s11999-010-1568-1
97 rdf:type schema:CreativeWork
98 https://doi.org/10.1016/j.arth.2014.04.036 schema:sameAs https://app.dimensions.ai/details/publication/pub.1042123078
99 rdf:type schema:CreativeWork
100 https://doi.org/10.1016/j.arth.2015.11.010 schema:sameAs https://app.dimensions.ai/details/publication/pub.1043238908
101 rdf:type schema:CreativeWork
102 https://doi.org/10.1016/j.arth.2016.04.030 schema:sameAs https://app.dimensions.ai/details/publication/pub.1005530488
103 rdf:type schema:CreativeWork
104 https://doi.org/10.1016/j.jhin.2011.06.001 schema:sameAs https://app.dimensions.ai/details/publication/pub.1000993891
105 rdf:type schema:CreativeWork
106 https://doi.org/10.1016/j.jtcvs.2012.09.040 schema:sameAs https://app.dimensions.ai/details/publication/pub.1014629586
107 rdf:type schema:CreativeWork
108 https://doi.org/10.1302/2046-3758.212.2000190 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040215919
109 rdf:type schema:CreativeWork
110 https://doi.org/10.2106/jbjs.m.01363 schema:sameAs https://app.dimensions.ai/details/publication/pub.1068903678
111 rdf:type schema:CreativeWork
112 https://www.grid.ac/institutes/grid.21729.3f schema:Organization
113 https://www.grid.ac/institutes/grid.239585.0 schema:Organization
114 https://www.grid.ac/institutes/grid.239915.5 schema:Organization
115 https://www.grid.ac/institutes/grid.413632.1 schema:Organization
116 https://www.grid.ac/institutes/grid.417432.7 schema:Organization
 




Preview window. Press ESC to close (or click here)


...