- Email: [email protected]
Use of Closed Incisional Negative Pressure Wound Therapy After Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection: A Prospective, Randomized Clinical Trial
Accepted Manuscript Use of Closed Incisional Negative Pressure Wound Therapy after Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection- A Prospective, Randomized Clinical Trial Jared M. Newman, MD, Marcelo B.P. Siqueira, MD, Alison K. Klika, MS, Robert M. Molloy, MD, Wael K. Barsoum, MD, Carlos A. Higuera, MD PII:
S0883-5403(18)31144-6
DOI:
https://doi.org/10.1016/j.arth.2018.11.017
Reference:
YARTH 56913
To appear in:
The Journal of Arthroplasty
Received Date: 27 August 2018 Revised Date:
19 October 2018
Accepted Date: 12 November 2018
Please cite this article as: Newman JM, Siqueira MBP, Klika AK, Molloy RM, Barsoum WK, Higuera CA, Use of Closed Incisional Negative Pressure Wound Therapy after Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection- A Prospective, Randomized Clinical Trial, The Journal of Arthroplasty (2018), doi: https://doi.org/10.1016/j.arth.2018.11.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Use of Closed Incisional Negative Pressure Wound Therapy after Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection- A Prospective, Randomized Clinical Trial
RI PT
Jared M. Newman, MD1 Marcelo B.P. Siqueira, MD2 Alison K. Klika, MS2 Robert M. Molloy, MD2 Wael K. Barsoum, MD3 Carlos A. Higuera, MD3 1
Department of Orthopaedic Surgery Cleveland Clinic Cleveland, Ohio 44195 3
EP
TE D
Department of Orthopaedic Surgery Cleveland Clinic Florida Weston, Florida 33331
M AN U
2
SC
Department of Orthopaedic Surgery SUNY Downstate Medical Center Brooklyn, New York 11203
AC C
Correspondence to: Alison K. Klika, MS Department of Orthopaedic Surgery Cleveland Clinic 9500 Euclid Ave. A41 Cleveland, Ohio 44195 Phone: (216)-444-4954 Email: [email protected]
ACCEPTED MANUSCRIPT
CONFLICT OF INTEREST STATEMENT The Journal of Arthroplasty (Adopted from the American Academy of Orthopaedic Surgeons disclosure statement)
The following form must be filled out completely and submitted by each author (example, 6 authors, 6 forms). If no discloser is required, please write/type “none” at the end of each sentence.
RI PT
Manuscript Title: Use of Closed Incisional Negative Pressure Wound Therapy after Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection- A Prospective, Randomized Clinical Trial Royalties from a company or supplier (The following conflicts were disclosed) none
2.
Speakers bureau/paid presentations for a company or supplier (The following conflicts were disclosed) none
3A.
Paid employee for a company or supplier (The following conflicts were disclosed) none
3B.
Paid consultant for a company or supplier (The following conflicts were disclosed) none
3C.
Unpaid consultants for a company or supplier (The following conflicts were disclosed) none
4.
Stock or stock options in a company or supplier (The following conflicts were disclosed) none
5. none
Research support from a company or supplier as a Principal Investigator (The following conflicts were disclosed)
6.
Other financial or material support from a company or supplier (The following conflicts were disclosed) none
7.
Royalties, financial or material support from publishers (The following conflicts were disclosed) none
8.
Medical/Orthopaedic publications editorial/governing board (The following conflicts were disclosed) none
9.
Board member/committee appointments for a society (The following conflicts were disclosed) none
AC C
EP
TE D
M AN U
SC
1.
Each author must sign AND print or type his/her name, date and submit a separate form In addition, one BLINDED Conflict of Interest form (no author names used) should be submitted per manuscript with all author disclosures.
Jared M. Newman Author Name (Print or Type)
Jared M. Newman Author Signature
8/17/2018 Date
ACCEPTED MANUSCRIPT
Table 1. Inclusion criteria of patients ciNPWT (n=80) 32 (40.0) 26 (32.5) 7 (8.8) 33 (41.3) 15 (18.8) 9 (11.3) 22 (27.5) 10 (12.5) 3 (3.8) 9 (11.3) 4 (5.0) 0 (0) 6 (7.5) 0 (0) 2 (2.5) 2.2 ± 1.1
P-value 0.871 0.867 0.598 0.873 0.189 0.633 0.032 0.199 0.311 0.024 0.230 0.316 0.147 0.155 1.000 0.009
RI PT
M AN U
Blood thinners other than aspirin postoperatively BMI ≥ 35 kg/m2 Peripheral vascular disease Depression Diabetes mellitus Current Smoker History of prior joint infection Current use of corticosteroids or immunomodulators Currently had cancer or hematological malignancy Inflammatory arthritis Renal failure or dialysis Malnutrition Liver disease Transplant status HIV infection Total
Control (n=80) 31 (38.8) 27 (33.8) 9 (11.3) 34 (42.5) 22 (27.5) 11 (13.8) 35 (43.8) 16 (20.0) 1 (1.3) 20 (25.0) 8 (10.0) 1 (1.3) 2 (2.5) 2 (2.5) 2 (2.5) 2.8 ± 1.4
SC
Variable
AC C
EP
TE D
*values are provided as frequency (%), except for Total, which is reported as mean ± standard deviation ciNPWT= closed incisional negative pressure wound therapy
ACCEPTED MANUSCRIPT
Table 2. Demographic factors
Age, years Gender Female Male Race White Non-white Body mass index, kg/m2 Procedure Revision THA Revision TKA Charlson/Deyo score 0 1 ≥2 ASA score ≤2 ≥3
Control (n=80) 65 ± 11
ciNPWT (n=79) 65 ± 11
35 (44) 45 (56)
39 (50) 40 (50)
P-value 0.119 0.478
RI PT
Variable
0.808
64 (81) 15 (19) 31.9 ± 7.5
40 (50) 40 (50)
38 (48) 41 (52)
24 (30) 21 (26) 35 (44)
32 (40) 18 (23) 29 (37)
M AN U
10 (12) 70 (88)
SC
66 (82) 14 (18) 33.4 ± 7.5
0.843 0.811
0.381
0.478
13 (16) 66 (84)
AC C
EP
TE D
*values are provided as frequency (%) except for Age and Body mass index, which are reported as mean ± standard deviation ciNPWT= closed incisional negative pressure wound therapy
ACCEPTED MANUSCRIPT
Table 4. Perioperative factors Variable Anesthesia General Spinal Knee approach Medial parapatellar Hip approach Posterolateral Direct lateral Anterolateral Operative time, min Length of incision, cm Hip Knee Estimated blood loss, mL Intraoperative transfusion Postoperative transfusion Length of stay, days
Control (n=80)
ciNPWT (n=79)
70 (88) 10 (12)
70 (89) 9 (11)
P-value 0.807
40 (50)
41 (52)
RI PT
0.874
0.990
30 (38) 7 (9) 1 (1) 204.7 ± 63.9
21.3 ± 5.4 21.5 ± 5.3 516 ± 416.5 22 (28) 20 (25) 4.4 ± 2.6
23.1 ± 7.1 19.8 ± 5.3 459 ± 402.1 15 (19) 11 (14) 3.7 ± 2.1
M AN U
SC
31 (39) 8 (10) 1 (1) 213 ± 63.7
0.400
0.230 0.052 0.390 0.189 0.100 0.078
*values are provided as frequency (%), except for operative time, length of incision, and estimated blood loss, which are reported as mean ± standard deviation
AC C
EP
TE D
ciNPWT= closed incisional negative pressure wound therapy
ACCEPTED MANUSCRIPT
Table 5. Number of patients with wound complications, readmissions, and reoperations at 2-, 4, and 12-weeks postoperative.
Re-operation 2-weeks 4-weeks 12-weeks
P-value
11 4 4 Total 19 (23.8%)
4 2 2 8 (10.1%)
0.030 0.348 0.326 0.022
6 3 10 Total 19 (23.8%)
5 4 7 16 (20.3%)
RI PT
ciNPWT (n=79)
SC
Readmission 2-weeks 4-weeks 12-weeks
Control (n=80)
M AN U
Variable Wound complications 2-weeks 4-weeks 12-weeks
1 2 7 Total 10 (12.5%)
0 1 1 2 (2.5%)
AC C
EP
TE D
ciNPWT= closed incisional negative pressure wound therapy
0.770 0.699 0.456 0.595
0.470 0.620 0.038 0.017
ACCEPTED MANUSCRIPT
Table 6. Types of wound complications and number of occurrences in each treatment arm
RI PT
ciNPWT 5 3 0 1 0 1 0 0 0 2 12
SC
Control 16 2 1 1 2 4 4 1 1 7 39
M AN U
Complications Drainage Cellulitis Blisters Hematoma Skin necrosis Wound dehiscence Non healing wound Suture abscess Surgical site infection Periprosthetic joint infection Total
AC C
EP
TE D
ciNPWT= closed incisional negative pressure wound therapy
ACCEPTED MANUSCRIPT
Table 3. Type of operation ciNPWT (n=79)
0 (0) 15 (18.8) 1 (1.3) 16 (20.0) 3 (3.8) 1 (1.3) 5 (6.3)
2 (2.5) 18 (22.5) 1 (1.3) 28 (35.4) 1 (1.3) 1 (1.3) 4 (5.0)
0.174 >0.05 >0.05 >0.05 0.0342 >0.05 >0.05 >0.05
5 (6.3)
7 (8.8)
>0.05
4 (5.0) 12 (15.0) 1 (1.3)
>0.05 0.0058 >0.05
SC
5 (6.3) 28 (35.0) 1 (1.3)
P-value
RI PT
Control (n=80)
M AN U
Variable Indication for revision, n (%) Arthrofibrosis Aseptic loosening Extensor mechanism deficiency Instability Metallosis/pain Periprosthetic fracture Polywear PJI with explantation and cement spacer placed Cement spacer exchange Re-implantation of prosthesis PJI with one stage revision
AC C
EP
TE D
ciNPWT= closed incisional negative pressure wound therapy; PJI=Periprosthetic Joint Infection
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
ACCEPTED MANUSCRIPT
Legend to Figures
AC C
EP
TE D
M AN U
SC
RI PT
Figure 1. Consort diagram showing patient screening and randomization into treatment and control arms.
S0883-5403(18)31144-6
DOI:
https://doi.org/10.1016/j.arth.2018.11.017
Reference:
YARTH 56913
To appear in:
The Journal of Arthroplasty
Received Date: 27 August 2018 Revised Date:
19 October 2018
Accepted Date: 12 November 2018
Please cite this article as: Newman JM, Siqueira MBP, Klika AK, Molloy RM, Barsoum WK, Higuera CA, Use of Closed Incisional Negative Pressure Wound Therapy after Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection- A Prospective, Randomized Clinical Trial, The Journal of Arthroplasty (2018), doi: https://doi.org/10.1016/j.arth.2018.11.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Use of Closed Incisional Negative Pressure Wound Therapy after Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection- A Prospective, Randomized Clinical Trial
RI PT
Jared M. Newman, MD1 Marcelo B.P. Siqueira, MD2 Alison K. Klika, MS2 Robert M. Molloy, MD2 Wael K. Barsoum, MD3 Carlos A. Higuera, MD3 1
Department of Orthopaedic Surgery Cleveland Clinic Cleveland, Ohio 44195 3
EP
TE D
Department of Orthopaedic Surgery Cleveland Clinic Florida Weston, Florida 33331
M AN U
2
SC
Department of Orthopaedic Surgery SUNY Downstate Medical Center Brooklyn, New York 11203
AC C
Correspondence to: Alison K. Klika, MS Department of Orthopaedic Surgery Cleveland Clinic 9500 Euclid Ave. A41 Cleveland, Ohio 44195 Phone: (216)-444-4954 Email: [email protected]
ACCEPTED MANUSCRIPT
CONFLICT OF INTEREST STATEMENT The Journal of Arthroplasty (Adopted from the American Academy of Orthopaedic Surgeons disclosure statement)
The following form must be filled out completely and submitted by each author (example, 6 authors, 6 forms). If no discloser is required, please write/type “none” at the end of each sentence.
RI PT
Manuscript Title: Use of Closed Incisional Negative Pressure Wound Therapy after Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection- A Prospective, Randomized Clinical Trial Royalties from a company or supplier (The following conflicts were disclosed) none
2.
Speakers bureau/paid presentations for a company or supplier (The following conflicts were disclosed) none
3A.
Paid employee for a company or supplier (The following conflicts were disclosed) none
3B.
Paid consultant for a company or supplier (The following conflicts were disclosed) none
3C.
Unpaid consultants for a company or supplier (The following conflicts were disclosed) none
4.
Stock or stock options in a company or supplier (The following conflicts were disclosed) none
5. none
Research support from a company or supplier as a Principal Investigator (The following conflicts were disclosed)
6.
Other financial or material support from a company or supplier (The following conflicts were disclosed) none
7.
Royalties, financial or material support from publishers (The following conflicts were disclosed) none
8.
Medical/Orthopaedic publications editorial/governing board (The following conflicts were disclosed) none
9.
Board member/committee appointments for a society (The following conflicts were disclosed) none
AC C
EP
TE D
M AN U
SC
1.
Each author must sign AND print or type his/her name, date and submit a separate form In addition, one BLINDED Conflict of Interest form (no author names used) should be submitted per manuscript with all author disclosures.
Jared M. Newman Author Name (Print or Type)
Jared M. Newman Author Signature
8/17/2018 Date
ACCEPTED MANUSCRIPT
Table 1. Inclusion criteria of patients ciNPWT (n=80) 32 (40.0) 26 (32.5) 7 (8.8) 33 (41.3) 15 (18.8) 9 (11.3) 22 (27.5) 10 (12.5) 3 (3.8) 9 (11.3) 4 (5.0) 0 (0) 6 (7.5) 0 (0) 2 (2.5) 2.2 ± 1.1
P-value 0.871 0.867 0.598 0.873 0.189 0.633 0.032 0.199 0.311 0.024 0.230 0.316 0.147 0.155 1.000 0.009
RI PT
M AN U
Blood thinners other than aspirin postoperatively BMI ≥ 35 kg/m2 Peripheral vascular disease Depression Diabetes mellitus Current Smoker History of prior joint infection Current use of corticosteroids or immunomodulators Currently had cancer or hematological malignancy Inflammatory arthritis Renal failure or dialysis Malnutrition Liver disease Transplant status HIV infection Total
Control (n=80) 31 (38.8) 27 (33.8) 9 (11.3) 34 (42.5) 22 (27.5) 11 (13.8) 35 (43.8) 16 (20.0) 1 (1.3) 20 (25.0) 8 (10.0) 1 (1.3) 2 (2.5) 2 (2.5) 2 (2.5) 2.8 ± 1.4
SC
Variable
AC C
EP
TE D
*values are provided as frequency (%), except for Total, which is reported as mean ± standard deviation ciNPWT= closed incisional negative pressure wound therapy
ACCEPTED MANUSCRIPT
Table 2. Demographic factors
Age, years Gender Female Male Race White Non-white Body mass index, kg/m2 Procedure Revision THA Revision TKA Charlson/Deyo score 0 1 ≥2 ASA score ≤2 ≥3
Control (n=80) 65 ± 11
ciNPWT (n=79) 65 ± 11
35 (44) 45 (56)
39 (50) 40 (50)
P-value 0.119 0.478
RI PT
Variable
0.808
64 (81) 15 (19) 31.9 ± 7.5
40 (50) 40 (50)
38 (48) 41 (52)
24 (30) 21 (26) 35 (44)
32 (40) 18 (23) 29 (37)
M AN U
10 (12) 70 (88)
SC
66 (82) 14 (18) 33.4 ± 7.5
0.843 0.811
0.381
0.478
13 (16) 66 (84)
AC C
EP
TE D
*values are provided as frequency (%) except for Age and Body mass index, which are reported as mean ± standard deviation ciNPWT= closed incisional negative pressure wound therapy
ACCEPTED MANUSCRIPT
Table 4. Perioperative factors Variable Anesthesia General Spinal Knee approach Medial parapatellar Hip approach Posterolateral Direct lateral Anterolateral Operative time, min Length of incision, cm Hip Knee Estimated blood loss, mL Intraoperative transfusion Postoperative transfusion Length of stay, days
Control (n=80)
ciNPWT (n=79)
70 (88) 10 (12)
70 (89) 9 (11)
P-value 0.807
40 (50)
41 (52)
RI PT
0.874
0.990
30 (38) 7 (9) 1 (1) 204.7 ± 63.9
21.3 ± 5.4 21.5 ± 5.3 516 ± 416.5 22 (28) 20 (25) 4.4 ± 2.6
23.1 ± 7.1 19.8 ± 5.3 459 ± 402.1 15 (19) 11 (14) 3.7 ± 2.1
M AN U
SC
31 (39) 8 (10) 1 (1) 213 ± 63.7
0.400
0.230 0.052 0.390 0.189 0.100 0.078
*values are provided as frequency (%), except for operative time, length of incision, and estimated blood loss, which are reported as mean ± standard deviation
AC C
EP
TE D
ciNPWT= closed incisional negative pressure wound therapy
ACCEPTED MANUSCRIPT
Table 5. Number of patients with wound complications, readmissions, and reoperations at 2-, 4, and 12-weeks postoperative.
Re-operation 2-weeks 4-weeks 12-weeks
P-value
11 4 4 Total 19 (23.8%)
4 2 2 8 (10.1%)
0.030 0.348 0.326 0.022
6 3 10 Total 19 (23.8%)
5 4 7 16 (20.3%)
RI PT
ciNPWT (n=79)
SC
Readmission 2-weeks 4-weeks 12-weeks
Control (n=80)
M AN U
Variable Wound complications 2-weeks 4-weeks 12-weeks
1 2 7 Total 10 (12.5%)
0 1 1 2 (2.5%)
AC C
EP
TE D
ciNPWT= closed incisional negative pressure wound therapy
0.770 0.699 0.456 0.595
0.470 0.620 0.038 0.017
ACCEPTED MANUSCRIPT
Table 6. Types of wound complications and number of occurrences in each treatment arm
RI PT
ciNPWT 5 3 0 1 0 1 0 0 0 2 12
SC
Control 16 2 1 1 2 4 4 1 1 7 39
M AN U
Complications Drainage Cellulitis Blisters Hematoma Skin necrosis Wound dehiscence Non healing wound Suture abscess Surgical site infection Periprosthetic joint infection Total
AC C
EP
TE D
ciNPWT= closed incisional negative pressure wound therapy
ACCEPTED MANUSCRIPT
Table 3. Type of operation ciNPWT (n=79)
0 (0) 15 (18.8) 1 (1.3) 16 (20.0) 3 (3.8) 1 (1.3) 5 (6.3)
2 (2.5) 18 (22.5) 1 (1.3) 28 (35.4) 1 (1.3) 1 (1.3) 4 (5.0)
0.174 >0.05 >0.05 >0.05 0.0342 >0.05 >0.05 >0.05
5 (6.3)
7 (8.8)
>0.05
4 (5.0) 12 (15.0) 1 (1.3)
>0.05 0.0058 >0.05
SC
5 (6.3) 28 (35.0) 1 (1.3)
P-value
RI PT
Control (n=80)
M AN U
Variable Indication for revision, n (%) Arthrofibrosis Aseptic loosening Extensor mechanism deficiency Instability Metallosis/pain Periprosthetic fracture Polywear PJI with explantation and cement spacer placed Cement spacer exchange Re-implantation of prosthesis PJI with one stage revision
AC C
EP
TE D
ciNPWT= closed incisional negative pressure wound therapy; PJI=Periprosthetic Joint Infection
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
ACCEPTED MANUSCRIPT
Legend to Figures
AC C
EP
TE D
M AN U
SC
RI PT
Figure 1. Consort diagram showing patient screening and randomization into treatment and control arms.