TY - JOUR
T1 - Does negative pressure wound therapy with irrigation improve clinical outcomes? A randomized clinical trial in patients with diabetic foot infections
AU - Lavery, Lawrence A.
AU - Davis, Kathryn E.
AU - La Fontaine, Javier
AU - Farrar, J. David
AU - Bhavan, Kavita
AU - Oz, Orhan K.
AU - Crisologo, Peter A.
N1 - Funding Information:
PAC has research funding from the American Diabetes Association , Cardinal Health, EO2 Concepts, Osiris Therapeutics, Avazzia, Pluristem Therapeutics, Inc.
Funding Information:
This study was funded and supported by the American Diabetes Association award numbers [1-15-TS-20] and [1-17-ICTS-056].KED has research funding from Cardinal Health, Avazzia, EO2 Concepts, MedImmune, Pluristem Therapeutics Inc., Osiris Therapeutics, and consulting agreements with EO2 Concepts, Cardinal Health, Bayer, Medline Industries, Boehringer Ingelheim, Medimmune.JL has research funding from Cardinal Health, Avazzia, KCI, EO2, Osiris Therapeutics, MedImmune, Pluristem Therapeutics, Inc.DF has research funding from the National Institute of Allergy and Infectious Diseases.KB has research funding from the American Diabetes Association.OKO has research funding from the American Diabetes Association.PAC has research funding from the American Diabetes Association, Cardinal Health, EO2 Concepts, Osiris Therapeutics, Avazzia, Pluristem Therapeutics, Inc.
Funding Information:
This study was funded and supported by the American Diabetes Association award numbers [ 1-15-TS-20 ] and [ 1-17-ICTS-056 ].
Funding Information:
LAL has research funding from Cardinal Health, KCI, EO2 Concepts, Osiris Therapeutics, Avazzia, Pluristem Therapeutics, Inc., and consulting agreements with EO2 Concepts, Cardinal Health, Bayer, Medline Industries, Boehringer Ingelheim, Medimmune.
Funding Information:
KED has research funding from Cardinal Health, Avazzia , EO2 Concept s, MedImmune , Pluristem Therapeutics Inc ., Osiris Therapeutics , and consulting agreements with EO2 Concepts, Cardinal Health, Bayer , Medline Industries , Boehringer Ingelheim, Medimmune .
Funding Information:
DF has research funding from the National Institute of Allergy and Infectious Diseases .
PY - 2020/10
Y1 - 2020/10
N2 - Aim: To compare the efficacy of Negative Pressure Wound Therapy (NPWT) with and without irrigation with 0.1% polyhexanide-betaine. Methods: We randomized 150 subjects in a 16-week RCT to compare healing in patients with diabetic foot infections. NPWT delivered at 125 mm Hg continuous pressure. NPWT-I were administered at 30 cc per hour. Results: There were no differences clinical treatment or outcomes: wound area after surgery (18.5 ± 19.0 vs. 13.4 ± 11.1 cm2, p = 0.50), duration of antibiotics (39.7 ± 21.0 vs. 38.0 ± 24.6 days, p = 0.40), number of surgeries (2.3 ± 0.67 vs. 2.2 ± 0.59, p = 0.85), duration of NPWT (148.1 ± 170.4 vs. 114.5 ± 135.1 h, p = 0.06), healed wounds (58.7% vs. 60.0%, p = 0.86), time to healing (56.3 ± 31.7 vs. 50.7 ± 27.8, p = 0.53), length of stay (13.8 ± 6.4 vs. 14.5 ± 11.2 days, p = 0.42), re-infection (20.0% vs. 22.7%, p = 0.69, and re-hospitalization (17.3% vs. 18.7, p = 0.83). Conclusions: The addition of irrigation to NPWT did not change clinical outcomes in patients with diabetic foot infections. Clinical trial number: NCT02463487, ClinicalTrials.gov.
AB - Aim: To compare the efficacy of Negative Pressure Wound Therapy (NPWT) with and without irrigation with 0.1% polyhexanide-betaine. Methods: We randomized 150 subjects in a 16-week RCT to compare healing in patients with diabetic foot infections. NPWT delivered at 125 mm Hg continuous pressure. NPWT-I were administered at 30 cc per hour. Results: There were no differences clinical treatment or outcomes: wound area after surgery (18.5 ± 19.0 vs. 13.4 ± 11.1 cm2, p = 0.50), duration of antibiotics (39.7 ± 21.0 vs. 38.0 ± 24.6 days, p = 0.40), number of surgeries (2.3 ± 0.67 vs. 2.2 ± 0.59, p = 0.85), duration of NPWT (148.1 ± 170.4 vs. 114.5 ± 135.1 h, p = 0.06), healed wounds (58.7% vs. 60.0%, p = 0.86), time to healing (56.3 ± 31.7 vs. 50.7 ± 27.8, p = 0.53), length of stay (13.8 ± 6.4 vs. 14.5 ± 11.2 days, p = 0.42), re-infection (20.0% vs. 22.7%, p = 0.69, and re-hospitalization (17.3% vs. 18.7, p = 0.83). Conclusions: The addition of irrigation to NPWT did not change clinical outcomes in patients with diabetic foot infections. Clinical trial number: NCT02463487, ClinicalTrials.gov.
KW - Amputation
KW - Diabetes
KW - Infection
KW - Negative pressure wound therapy
KW - Osteomyelitis
KW - Ulcer
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U2 - 10.1016/j.amjsurg.2020.02.044
DO - 10.1016/j.amjsurg.2020.02.044
M3 - Article
C2 - 32139102
AN - SCOPUS:85080865845
VL - 220
SP - 1076
EP - 1082
JO - American Journal of Surgery
JF - American Journal of Surgery
SN - 0002-9610
IS - 4
ER -