Effectiveness of a hydrophobic dressing for microorganisms’ colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO‐UV Study)

Abstract

Aim To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact ® ) against a silver dressing (Aquacel ® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health‐related quality of life, level of pain, and time to complete healing. Design Open randomized controlled trial, with blinded endpoint. Methods Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 participants recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound‐related variables (area, exudate, and time to healing), level of pain, adverse effects, and health‐related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA‐typing technique through polymerase chain reaction to obtain the level of colony‐forming units. Measures will be collected at baseline, 4, 8, and 12 weeks. Discussion Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced. Impact Current evidence about the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design based on conditions of routine clinical practice in Primary Health Care and nursing homes.

Incorporating Nigella sativa nanoemulsion into gelatin-guar gum films for enhanced healing of wound infections

“…Additionally, hydrophobic films can effectively act as a barrier to microorganisms and remove excess exudates from the wound surface, promoting an optimal environment for wound healing. 32 The decrease in hydrophobicity when oil NE is incorporated into the film matrix can be attributed to several factors. The addition of NEs can lead to an increase in the molecular spaces between the protein, resulting in decreased hydrophobicity.…”

A Novel Tool for a Challenging Disease: Stasis Leg Ulcers Assessed Using QFlow in Triggered Angiography Noncontrast Enhanced Magnetic Resonance Imaging

“…Coexisting symptoms, such as itching, swelling, depression, fatigue, pain, and social isolation, are common, and the latter three problems affect up to 50% of individuals with SLUs. The main reasons for such ulcers were thought ambulatory venous hypertension from primary venous reflux, right-sided heart failure, DVT, or venous outflow obstruction [ 2 , 17 , 18 , 19 ]. Sometimes, other causes of unhealed leg ulcers cannot be easily differentiated through conventional venous evaluation [ 2 , 4 , 20 ].…”

Stasis Leg Ulcers: Venous System Revises by Triggered Angiography Non-Contrast-Enhanced Sequence Magnetic Resonance Imaging

“…The main etiology of such ulcers was previously identified to be ambulatory venous hypertension, which may be caused by primary venous valvular reflux, right-sided heart failure, poor lymph drainage, DVT, and venous outflow obstruction. Other pathophysiology of venous return and of venous ulcer development is proposed, including inadequate microorganisms’ colonization, iceberg hypothesis of chronic venous insufficiency, and venous hypoxia in the microcirculation in the skin level [ 1 , 7 , 8 , 9 ]. However, other etiologies of unhealed leg ulcers are not easily differentiated according to conventional venous evaluation [ 1 , 3 , 10 ].…”