Clinical performance and safety of a debridement pad with abrasive and non-abrasive fibres

TY - JOUR

T1 - Clinical performance and safety of a debridement pad with abrasive and non-abrasive fibres

AU - Stürmer, Ewa

AU - Debus, Eike Sebastian

AU - Atkin, Leanne

PY - 2024/6/2

Y1 - 2024/6/2

N2 - BACKGROUND: Debridement is key to removing devitalised tissue, debris and biofilm as part of wound-bed preparation. Unlike many other methods of debridement, mechanical debridement with a pad is effective enough to be used independently without an adjunctive method of debridement, while being more accessible than other standalone options.OBJECTIVE: To explore the clinical performance and safety of a debridement pad with both abrasive and non-abrasive surfaces in daily clinical practice.METHODS: This was a prospective, non-controlled, non-randomised, single-arm, open-label, multicentred observational evaluation. Inclusion criteria were wounds >4 cm2 covered with at least 30% debris, necrotic tissue or slough in patients aged ≥18 years. The treatment protocol comprised a single application of the debridement pad. The primary outcome measure was the amount of necrotic tissue, slough or debris in the wound bed. Secondary outcomes included the appearance of the wound bed, edges and periwound skin; self-reported pain scores; foreseeable negative impacts; and clinician satisfaction.RESULTS: A total of 62 participants with a variety of wound types were included in the analysis. Most wounds (87%) had been present for over 3 months and had high or moderate exudate levels (90%). A significant reduction was observed in all three parameters: necrotic tissue (p=0.043), slough (p<0.001) and debris (p<0.001). Necrotic tissue, slough and debris showed mean relative reductions of 40%, 72% and 40%, respectively. Of participants, 84% did not experience an increase in pain during the debridement procedure.CONCLUSION: This clinical real-world data shows the debridement pad to be an effective and well-tolerated device for debridement and wound bed preparation.

AB - BACKGROUND: Debridement is key to removing devitalised tissue, debris and biofilm as part of wound-bed preparation. Unlike many other methods of debridement, mechanical debridement with a pad is effective enough to be used independently without an adjunctive method of debridement, while being more accessible than other standalone options.OBJECTIVE: To explore the clinical performance and safety of a debridement pad with both abrasive and non-abrasive surfaces in daily clinical practice.METHODS: This was a prospective, non-controlled, non-randomised, single-arm, open-label, multicentred observational evaluation. Inclusion criteria were wounds >4 cm2 covered with at least 30% debris, necrotic tissue or slough in patients aged ≥18 years. The treatment protocol comprised a single application of the debridement pad. The primary outcome measure was the amount of necrotic tissue, slough or debris in the wound bed. Secondary outcomes included the appearance of the wound bed, edges and periwound skin; self-reported pain scores; foreseeable negative impacts; and clinician satisfaction.RESULTS: A total of 62 participants with a variety of wound types were included in the analysis. Most wounds (87%) had been present for over 3 months and had high or moderate exudate levels (90%). A significant reduction was observed in all three parameters: necrotic tissue (p=0.043), slough (p<0.001) and debris (p<0.001). Necrotic tissue, slough and debris showed mean relative reductions of 40%, 72% and 40%, respectively. Of participants, 84% did not experience an increase in pain during the debridement procedure.CONCLUSION: This clinical real-world data shows the debridement pad to be an effective and well-tolerated device for debridement and wound bed preparation.

KW - Humans

KW - Debridement/methods

KW - Male

KW - Prospective Studies

KW - Female

KW - Middle Aged

KW - Aged

KW - Adult

KW - Wound Healing

KW - Wounds and Injuries/therapy

KW - Aged, 80 and over

KW - Necrosis

U2 - 10.12968/jowc.2024.0162

DO - 10.12968/jowc.2024.0162

M3 - SCORING: Journal article

C2 - 38843013

VL - 33

SP - 408

EP - 416

JO - J WOUND CARE

JF - J WOUND CARE

SN - 0969-0700

IS - 6

ER -