Effect of supplements/intensive nutrition on pressure ulcer healing: a multicentre, randomised controlled study

Abstract

Objective: To investigate the effectiveness of an intensive nutrition intervention or use of wound healing supplements compared with standard nutritional care in pressure ulcer (PU) healing in hospitalised patients. Method: Adult patients with a Stage II or greater PU and predicted length of stay (LOS) of at least seven days were eligible for inclusion in this pragmatic, multicentre, randomised controlled trial (RCT). Patients with a PU were randomised to receive either: standard nutritional care (n=46); intensive nutritional care delivered by a dietitian (n=42); or standard care plus provision of a wound healing nutritional formula (n=43). Relevant nutritional and PU parameters were collected at baseline and then weekly or until discharge. Results: Of the 546 patients screened, 131 were included in the study. Participant mean age was 66.1±16.9 years, 75 (57.2%) were male and 50 (38.5%) were malnourished at recruitment. Median length of stay was 14 (IQR: 7–25) days and 62 (46.7%) had ≥2 PUs at the time of recruitment. Median change from baseline to day 14 in PU area was –0.75cm2 (IQR: –2.9_–0.03) and mean overall change in Pressure Ulcer Scale for Healing (PUSH) score was –2.9 (SD 3.2). Being in the nutrition intervention group was not a predictor of change in PUSH score, when adjusted for PU stage or location on recruitment (p=0.28); it was not a predictor of PU area at day 14, when adjusted for PU stage or area on recruitment (p=0.89) or PU stage and PUSH score on recruitment (p=0.91), nor a predictor of time to heal. Conclusion: This study failed to confirm a significant positive impact on PU healing of use of an intensive nutrition intervention or wound healing supplements in hospitalised patients. Further research that focuses on practical mechanisms to meet protein and energy requirements is needed to guide practice.

The Clinical and Cost-Effectiveness of an Individualized Nutritional CAre (INCA) Bundle versus Standard Care for Adults with Pressure Injuries Receiving Home Nursing Services: A Protocol for a Cluster Randomized and Pragmatic Clinical Trial with an Economic Evaluation

“…Pressure injuries are a complex and prevalent healthcare concern, particularly in community settings. Existing nutritional studies on PI wound healing have primarily focused on single-component interventions or hospital-based populations, often lacking individualized dietary support [ 17 , 19 , 20 , 22 ]. Recent trials have explored multi-component interventions but have shown statistically non-significant results [ 20 , 22 ].…”

“…Existing nutritional studies on PI wound healing have primarily focused on single-component interventions or hospital-based populations, often lacking individualized dietary support [ 17 , 19 , 20 , 22 ]. Recent trials have explored multi-component interventions but have shown statistically non-significant results [ 20 , 22 ]. This study addresses these gaps by implementing a comprehensive PI care bundle intervention, including education, dietetic support with medical nutritional supplements, and trained home care/community nurses in nutrition care.…”

“…Early nutritional studies on PI wound healing generally implement simple [ 15 ] single-component interventions using specialized medical nutritional supplements [ 16 , 17 , 18 , 19 ] or primarily concentrate on hospitalized patient populations, where the intervention period is inadequate to deliver a positive outcome [ 19 , 20 ]. Recently, a cluster randomized controlled trial (RCT) of 1600 hospitalized patients using a complex multi-component PI prevention intervention (posters/DVD and face-to-face education) showed a statistically non-significant reduced hazard ratio for new PI(s) developed [ 21 , 22 ].…”

The Clinical and Cost-Effectiveness of an Individualised Nutritional CAre (INCA) Bundle Versus Standard Care for Adults with Pressure Injuries Receiving Home Nursing Services: a Protocol for a Cluster Randomised, Pragmatic Clinical Trial with an Economic Evaluation.

“…Pressure injuries are a complex and prevalent healthcare concern, particularly in community settings. (19,21) This study addresses these gaps by implementing a comprehensive PI care bundle intervention, including education, dietetic support with medical nutritional supplements, and trained homecare/community nurses in nutrition care. The primary objectives are to evaluate the clinical and cost-effectiveness of the intervention on PI-related outcomes.…”

“…Early nutritional studies on PI wound healing generally implements simple (14) single-component interventions using specialized medical nutritional supplements (15)(16)(17)(18), or primarily concentrated on hospitalised patient populations, where the intervention period is inadequate to deliver a positive outcome. (18,19) Recently, a cluster randomised controlled trial (RCT) of 1600 hospitalised patients using a complex multi-component PI prevention intervention (posters/DVD and face-to-face education) showed a statistically non-signi cant reduced hazard ratio for new PI(s) developed. (20,21) However, one of the limitations for this study was the lack of individualised nutritional intervention with supervision.…”