Does negative pressure wound therapy with irrigation improve clinical outcomes? A randomized clinical trial in patients with diabetic foot infections

Am J Surg. 2020 Oct;220(4):1076-1082. doi: 10.1016/j.amjsurg.2020.02.044. Epub 2020 Feb 27.

Abstract

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.

Keywords: Amputation; Diabetes; Infection; Negative pressure wound therapy; Osteomyelitis; Ulcer.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Biguanides / administration & dosage*
  • Diabetic Foot / therapy*
  • Disinfectants / administration & dosage
  • Female
  • Humans
  • Male
  • Middle Aged
  • Negative-Pressure Wound Therapy / methods*
  • Therapeutic Irrigation / methods*
  • Treatment Outcome
  • Wound Healing*

Substances

  • Biguanides
  • Disinfectants
  • polihexanide

Associated data

  • ClinicalTrials.gov/NCT02463487