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The impact of negative-pressure wound therapy with instillation on wounds requiring operative debridement: Pilot randomised, controlled trial.

ABSTRACT: Presence of bacteria in wounds can delay healing. Addition of a regularly instilled topical solution over the wound during negative-pressure wound therapy (NPWT) may reduce bioburden levels compared with standard NPWT alone. We performed a prospective, randomised, multi-centre, post-market trial to compare effects of NPWT with instillation and dwell of polyhexamethylene biguanide solution vs NPWT without instillation therapy in wounds requiring operative debridement. Results showed a significantly greater mean decrease in total bacterial counts from time of initial surgical debridement to first dressing change in NPWT plus instillation (n = 69) subjects compared with standard NPWT (n = 63) subjects (-0.18 vs 0.6 log₁₀ CFU/g, respectively). There was no significant difference between the groups in the primary endpoint of required inpatient operating room debridements after initial debridement. Time to readiness for wound closure/coverage, proportion of wounds closed, and incidence of wound complications were similar. NPWT subjects had 3.1 times the risk of re-hospitalisation compared with NPWT plus instillation subjects. This study provides a basis for exploring research options to understand the impact of NPWT with instillation on wound healing.

SUBMITTER: Kim PJ

PROVIDER: S-EPMC7540575 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:To investigate the effect of negative pressure wound therapy (NPWT) with and without instillation (NPWTi) on in vitro mature biofilm. METHODS:Mature biofilms of Pseudomonas aeruginosa and Staphylococcus aureus were grown under shear (130 rpm) on polycarbonate coupons in a CDC biofilm reactor for 3 days. Coupons containing biofilms were placed in a sterile petri dish and sealed using NPWT or NPWTi. Coupons were exposed to treatment for 24 h with NPWT alone or with instillation of: Povidone iodine solution (PVP-I) (10% w/v equivalent to 1% w/v available iodine, BETADINE®, Mundipharma, Singapore), surfactant based antimicrobial solution with polyhexamethylene biguanide (SBPHMB) (Prontosan®, B Braun Medical, Melsungen, Germany), Gentamicin 1 µg/mL (GM) (G1264 Sigma-Aldrich Pty Ltd., Castle Hill, Australia) Rifampicin 24 µg/mL (RF) (R3501 Sigma-Aldrich Pty Ltd., Castle Hill, Australia) and NaCl 0.9% (Baxter, Deerfield, IL, USA). Bacterial cell viability and biofilm architecture pre-and post-treatment were assessed using colony forming units (cfu), Live/Dead viability staining, confocal laser scanning microscopy (CLSM) and scanning electron microscopy (SEM). RESULTS:Significant reductions were obtained in S. aureus biofilm thickness (65%) and mass (47%) when treated with NPWTi as compared to NPWT only. NPWTi with instillation of SBPHMB, PVP-I and RF achieved between 2 and 8 log10 reductions against S. aureus biofilm (p < 0.05?0.001). Conversely, PVP-I and SBMO achieved a 3.5 log10 reduction against P. aeruginosa (p < 0.05). CONCLUSIONS:NPWT alters biofilm architecture by reducing biofilm thickness and mass, but this does not affect bacterial cell viability. NPWT with instillation of certain antimicrobials solutions may provide a further synergistic effect in reducing the number of viable biofilm microorganisms. Our in vitro model may be used for screening the effectiveness of antimicrobials used under instillation prior to animal or human studies.

Project description:BACKGROUND:Negative pressure wound therapy (NPWT) is a widely used method of wound treatment. We performed a systematic review of randomised controlled trials (RCTs) comparing the patient-relevant benefits and harms of NPWT with standard wound therapy (SWT) in patients with wounds healing by secondary intention. METHODS:We searched for RCTs in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and study registries (last search: July 2018) and screened reference lists of relevant systematic reviews and health technology assessments. Manufacturers and investigators were asked to provide unpublished data. Eligible studies investigated at least one patient-relevant outcome (e.g. wound closure). We assessed publication bias and, if feasible, performed meta-analyses, grading the results into different categories (hint, indication or proof of a greater benefit or harm). RESULTS:We identified 48 eligible studies of generally low quality with evaluable data for 4315 patients and 30 eligible studies with missing data for at least 1386 patients. Due to potential publication bias (proportion of inaccessible data, 24%), we downgraded our conclusions. A meta-analysis of all wound healing data showed a significant effect in favour of NPWT (OR 1.56, 95% CI 1.15 to 2.13, p = 0.008). As further analyses of different definitions of wound closure did not contradict that analysis, we inferred an indication of a greater benefit of NPWT. A meta-analysis of hospital stay (in days) showed a significant difference in favour of NPWT (MD - 4.78, 95% CI - 7.79 to - 1.76, p = 0.005). As further analyses of different definitions of hospital stay/readmission did not contradict that analysis, we inferred an indication of a greater benefit of NPWT. There was neither proof (nor indication nor hint) of greater benefit or harm of NPWT for other patient-relevant outcomes such as mortality and adverse events. CONCLUSIONS:In summary, low-quality data indicate a greater benefit of NPWT versus SWT for wound closure in patients with wounds healing by secondary intention. The length of hospital stay is also shortened. The data show no advantages or disadvantages of NPWT for other patient-relevant outcomes. Publication bias is an important problem in studies on NPWT, underlining that all clinical studies need to be fully reported.

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The impact of negative-pressure wound therapy with instillation on wounds requiring operative debridement: Pilot randomised, controlled trial.

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