What are the clinical trials and studies on the use of polyurethane dressings on wounds?

Clinical Trials and Studies on Polyurethane Dressing Use in Wounds

Major Meta-Analyses and Systematic Reviews

The strongest evidence for polyurethane-based negative pressure wound therapy (NPWT) comes from the Strugala et al. 2017 meta-analysis, which demonstrated a 58% reduction in surgical site infections across 1,863 patients. 1

High-Quality Meta-Analyses on Closed Surgical Incisions

• Strugala V et al. 2017 enrolled 1,863 patients (2,202 incisions) across 10 randomized controlled trials and 6 observational studies evaluating the PICO single-use NPWT system with polyurethane foam 1

  • Randomized studies showed 51% SSI reduction (9.7% to 4.8%, RR 0.49, P < 0.0001) 1
  • Observational studies showed 67% SSI reduction (22.5% to 7.4%, RR 0.32, P < 0.0001) 1
  • Pooled data demonstrated 58% SSI reduction (12.5% to 5.2%, RR 0.43, P < 0.0001) regardless of surgery type 1
  • Wound dehiscence reduced from 17.4% to 12.8% (RR 0.71, P < 0.01) 1
  • Hospital length of stay reduced by 0.47 days (P < 0.0001) 1
  • Grade of Recommendation: 1A 1

• Sahebally SM et al. 2018 analyzed 1,266 patients across 9 studies (3 RCTs, 2 prospective, 4 retrospective) for laparotomy wounds 1

  • Significantly lower SSI rates with closed incisional NPWT (pooled OR 0.25,95% CI 0.12-0.52, P < 0.001) 1
  • Colorectal-specific analysis showed even greater benefit (pooled OR 0.16,95% CI 0.07-0.36, P < 0.001) 1
  • No significant difference in seroma rates (pooled OR 0.38, P = 0.11) or dehiscence (pooled OR 2.03, P = 0.25) 1
  • Grade of Recommendation: 2C 1

• Sandy-Hodgetts K et al. 2015 systematic review of 1,277 patients across 8 studies (RCTs, quasi-experimental, cohort studies) 1

  • NPWT may be considered for closed surgical incisions in high-risk adults 1
  • Grade of Recommendation: 2C 1

• Webster J et al. 2019 Cochrane systematic review of 2,957 participants across 30 interventional studies 1

  • Included abdominal/colorectal (n=5), cesarean sections (n=5), knee/hip arthroplasties (n=5), groin (n=5), fractures (n=5), and other surgeries 1
  • Found uncertainty regarding mortality, dehiscence, seroma, and cost outcomes 1
  • Called for larger, well-designed trials focusing on difficult-to-heal wounds (sternal wounds, obese patients) 1
  • Grade of Recommendation: 2C 1

Prospective Studies on Contaminated/Infected Wounds

• Lozano-Balderas G et al. 2017 prospective randomized study of 81 patients with contaminated/dirty-infected laparotomy wounds 1

  • Infection rates: 0% with vacuum-assisted closure vs. 37% with primary closure vs. 17% with delayed primary closure 1
  • Statistical significance favored vacuum-assisted group (P < 0.05) 1
  • Grade of Recommendation: 1C 1

• Katsuki Danno et al. 2018 prospective study of 28 patients undergoing abdominal surgery for lower-GI perforation peritonitis 1

  • NPWT effective for preventing SSI in peritonitis cases 1
  • Grade of Recommendation: 2C 1

Studies on Open Abdomen Management

The International Journal of Surgery published systematic review and evidence-based recommendations for NPWT in open abdomen wounds 1:

• Miller et al. 2004 reported almost 50% of successful primary fascial closures performed "late" (after 9 days of NPWT, as late as 21 days) 1
• Multiple studies documented late closures: 18 days, 49 days with NPWT 1
• Grade B recommendation for application of incisional NPWT on closed incisions to facilitate healing 1
• Comparative studies showed significant reduction in wound complications including dehiscence vs. standard gauze dressings 1
• Grade D recommendation for NPWT management of entero-atmospheric fistula output 1

Diabetic Foot Ulcer Studies

The International Working Group on the Diabetic Foot (IWGDF) 2023 guidelines reviewed multiple studies 1:

• Studies in post-operative diabetic wounds showed positive benefits after partial foot amputation 1
• Two moderate risk-of-bias studies reported beneficial healing effects, though outcomes were not blinded 1
• One moderate risk-of-bias study showed no difference in healing after soft tissue incision and drainage 1
• For chronic non-surgical diabetic ulcers: insufficient evidence to establish benefit 1
• Nine studies reported amputation outcomes; lowest risk-of-bias studies noted no difference 1
• Five studies showed no difference in new infection rates between groups 1
• Three studies documented lower resource use or better cost-effectiveness (post hoc analyses, low certainty) 1
• Strong recommendation against NPWT for non-surgical diabetic foot ulcers due to lack of evidence 2

Material Science and Polyurethane Foam Studies

• Evaluation study (1997) of 61 patients comparing polyurethane foam vs. hydrocellular dressing 3

  • 20 leg ulcers, 20 Grade 2-3 pressure sores, 21 other wounds (traumatic, acute, chronic, burns) 3
  • Both dressings remained in place approximately 2.5 days regardless of wound type 3
  • No statistically significant differences in surrounding skin condition, wound size reduction, comfort, or ease of use 3

• PEG/APTES-modified polyurethane foam study (2023) in diabetic rat models 4

  • PUESi dressing showed better anti-adhesion properties and absorption capacity with deformation 4
  • Shortened inflammatory phase and enhanced collagen deposition in both non-diabetic and diabetic animal models 4
  • Enhanced wound healing via micronegative-pressure generation through high absorption capacity 4

• Systematic review (2022) on polyurethane dressing design for wound-healing stages 5

  • Current research focuses on covering all stages with single material but requires frequent replacement 5
  • Little emphasis on hemostasis stage; further characterization needed to correlate mechanical/physicochemical properties with biological properties 5
  • Most literature based on histological tests of explants rather than comprehensive biological property assessment 5

• Electrospun mupirocin-loaded polyurethane fiber study (2017) for burn wounds 6

  • Demonstrated satisfactory antibacterial activity especially against Staphylococcus aureus 6
  • Scaffolds were biocompatible and safe for cell attachment 6
  • Histological analysis showed no obvious inflammation reaction in rat models 6

Clinical Case Series

• Clinical cases (2012) using polyacrylate fibers with TLC and polyurethane foam dressings with TLC-NOSF 7
  • Chronic wounds of vascular origin and pressure ulcers 7
  • Initial debridement with hidrodetersive polyacrylate fibers, followed by polyurethane foam dressing 7

Critical Implementation Guidelines

Polyurethane foam-based NPWT should never be applied to infected wounds until complete surgical debridement removes all necrotic tissue, as mandated by the World Journal of Emergency Surgery 2018 WSES/SIS-E consensus guidelines. 2

• Complete surgical debridement must extend into healthy-looking tissue before NPWT application 2
• NPWT contraindicated in wounds with residual necrotic tissue or uncontrolled infection 2
• Lower pressures (75-80 mmHg) appropriate for vulnerable anatomic areas 2
• Dressing changes every 2-3 days, with average of 5 changes required for optimal granulation 2

Foam-Specific Properties Critical for NPWT Function

• Polyurethane foam compresses under negative pressure, providing "splinting effect" with constant medial traction (Grade B recommendation) 8
• Foam-based NPWT is independent predictor of early fascial closure, while non-compressing materials are not 8
• System evacuates approximately 800ml of fluid, preventing pooling 8
• Prospective comparative studies show significantly increased fascial closure rates with commercial foam products vs. improvised alternatives 8
• Improvised materials like surgical towels show inferior outcomes; vac-pac technique with non-foam materials not an independent predictor of successful closure 8