References
The influence of adequate debridement and placental-derived allografts on diabetic foot ulcers
Abstract
Objective:
To determine the role of debridement when patients are using placental-derived allografts (PDAs), data from two prospective, multicentre, randomised controlled trials (RCTs) were evaluated for the quality or adequacy of debridement on diabetic foot ulcers (DFUs) treated with PDAs. Results were compared with real-world findings via a retrospective analysis of 2015–2019 Medicare claims for DFUs.
Method:
Debridement adequacy in the prospective RCTs was adjudicated by three blinded wound care specialists. Treatments included two PDAs, dehydrated human amnion/chorion membrane (DHACM, n=54) or dehydrated human umbilical cord (DHUC, n=101), compared with standard of care (SOC, n=110). The key outcome was the influence of adequate debridement on rates of complete closure within 12 weeks. Additionally, a retrospective analysis of 2015–2019 Medicare claims for DFUs that received routine debridement at intervals ranging from every 1–7 days (18,900 total episodes), 8–14 days (35,728 total episodes), and every 15 days or greater (34,330 total episodes) was performed.
Results:
Within the RCTs, adequate debridement occurred in 202/265 (76%) of patients, 90/110 (82%) SOC ulcers, 45/54 (83%) of DHACM-treated ulcers, and in 67/101 (66%) of DHUC-treated ulcers. Complete closure occurred in 150/202 (74%) of adequately debrided ulcers, and in only 13/63 (21%) of ulcers without adequate debridement, p<0.0001. Debridement was the most significant factor for closure even when controlling for other clinical characteristics. Within the Medicare claims data 21% (18,900/88,958) of episodes treated with SOC only had debridement intervals of ≤7 days. Short debridement intervals in combination with the use of DHACM demonstrated statistically significant better outcomes than SOC including: 65% fewer major amputations (p<0.0001), higher DFU resolution rates (p=0.0125), 42% fewer emergency room visits (p<0.0001) and reduced usage of other hospital resources (admissions and readmissions).
Conclusion:
Prospectively collected data examining the quality of debridement and retrospectively analysed data examining the frequency of debridement supports routine adequate wound debridement, particularly at intervals of seven days, as an essential component of wound care. Optimal use of placental-derived allografts improves outcomes and lowers the use of healthcare resources.
Wound healing classically progresses through four overlapping stages: haemostasis, inflammatory, proliferative, and maturation/remodelling. Chronicity occurs when a wound fails to progress through the standard phases of wound healing in an organised and timely manner. However, data suggests that the more frequent the debridements, the better the healing result.1 Furthermore, adequate serial debridements can sequentially, over time, reduce the inflammation in a hard-to-heal wound, thus affording a rebalancing of the healing cascade and converting the unfavourable molecular environment of a hard-to-heal wound into a pseudoacute wound molecular environment,2 thus preparing the wound for advanced treatments, such as placental derived allografts (PDA).
Major international organisations strongly recommend regular, sharp debridement when blood flow is adequate for stalled diabetic foot ulcers (DFUs).3,4,5,6 A significant barrier to achieving this consensus objective is the actuality that there is no standardised surgical wound debridement training that all wound care specialists receive, resulting in a wide variance in opinions among clinicians as to what constitutes adequate debridement.7 A large retrospective study of >312,000 wounds showed that a higher frequency of debridement improves healing outcomes with quicker healing rates, yet wounds receiving advanced therapies were excluded from analysis. Advanced therapies are important in the TIMERS framework for managing hard-to-heal wounds which emphasises the value of managing devitalised tissue, biofilm/infection, moisture, wound edge, repair/regeneration, and social factors.8 Specifically, there is a need to ‘step up’ to advanced therapies when the trajectory towards wound closure stalls.9 The role of advanced therapies and the importance of continued good wound care including debridement was evaluated in this study.
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