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| Name | Class |
|---|---|
| BSN Medical GmbH | INDUSTRY |
| Andalusian Health Service | OTHER_GOV |
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This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.
Chronic wounds with torpid evolution are a real challenge for health services today. In the case of venous ulcers, it is estimated that more than 80% of these wounds may be colonized or infected by bacteria, which is associated with its chronification by delaying the healing process.
The most widespread therapeutic strategy in routine clinical practice is the use of silver dressings, due to its high antimicrobial power, although the effectiveness of these in venous ulcers is not supported by solid evidence. In addition, there are some uncertainties about the possible adverse effects of systemic absorption of silver molecules, as well as bacterial resistance to silver and the high cost associated with prolonged treatments.
In this sense, a novel method to deal with this problem is the use of dressings with high hydrophobic power, such as CUTIMED®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CUTIMED | Experimental | After an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply the CUTIMED dressing. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage. If the wound exudate decreases, or the removal of the dressing is difficult, it will be changed to CUTIMED gel; in case of abundant exudate, the use of alginate without silver will be allowed for the treatment, because it is neutral with the bacterial load, placed on the CUTIMED dressing. Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks). |
|
| AQUACEL silver | Active Comparator | After an initial culture to determine the bacterial load by smear, we will proceed to the cure of the ulcer by washing the area with physiological saline solution and to mechanical debridement, if necessary, to apply Aquacel-Ag. It will be covered with a secondary gauze dressing and a double compression bandage with a normal crepe bandage. Primary and secondary end-points will be measured at baseline and at 4, 8 and 12 weeks, except quality of life (only baseline and at 12 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CUTIMED | Combination Product | Hydrophobic Dressing |
| |
| AQUACEL silver |
| Measure | Description | Time Frame |
|---|---|---|
| Microorganisms' Colonization Level | Evaluated by Reverse Transcription Polymerase Chain Reaction (RT-PCR) identification technique and quantified in colony forming units (CFU) and in ng of bacterial DNA per μL of vascular ulcer exudate. | Change from baseline, at 4, 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain due to the wound | Measured with tha Visual Analogue Scale (VAS): Minimum score=1; Maximum score=10. | Change from baseline at 4, 8 and 12 weeks |
| Wound size (wound reduction percentage) | It will be evaluated by planimetry with PictZar 7.5 software |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing evolution | Measured with "Resultados esperados de la valoración y evolución de la cicatrización de las heridas crónicas" (Expected results of chronic wound healing assessment and evolution), RESVECH 2.0 scale. The punctuation varies forn 0 to 35, with 6 subscales: Wound size, Depth/affected tissues, Borders, Type of tissue in the wound bed, Type of exudate and Infection/inflammation | Baseline, 4, 8 and 12 weeks |
Inclusion Criteria:
Adult patients with chronic venous vascular ulcer located in lower limbs with signs of critical colonization, according to the criteria of Lazareth and Moore, which imply the presence of at least 3 of the following five:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José Miguel Morales Asencio, PhD | Contact | 0034951952833 | jmmasen@uma.es | |
| Juan Carlos Morilla Herrera, PhD | Contact | jc.morilla.sspa@juntadeandalucía.es |
| Name | Affiliation | Role |
|---|---|---|
| José Miguel Morales Asencio, PhD | University of Malaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Málaga | Recruiting | Málaga | 29071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27112627 | Background | Gonzalez de la Torre H, Quintana-Lorenzo ML, Perdomo-Perez E, Verdu J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017 Apr;14(2):360-368. doi: 10.1111/iwj.12610. Epub 2016 Apr 25. | |
| 1366259 | Background | Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992 Aug;1(2):113-9. doi: 10.3109/08037059209077502. |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D001424 | Bacterial Infections |
| D007869 | Leg Injuries |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Other |
Silver Dressing |
|
| Baseline, 4, 8 and 12 weeks |
| Healing time | This outcome will be measure by number of days until healing | Change from baseline at 4, 8 and 12 weeks |
| Complete wound healing (Resvech 2.0 score) | Complete healing will be considered with a 0 score in the fourth dimension of the Resvech 2.0 scale | Change from baseline at 4, 8 and 12 weeks |
| Patient quality of life | Measured with Charing Cross Venous Ulcer Questionnaire (CCVUQ), in its Spanish version. The CCVUQ is composed of 22 items that determine four important dimensions for health: the social function, domestic activities, the aesthetic dimension and the emotional state. Each item should be assessed using a Likert scale with a punctuation from 1 to 5. In their interpretation, lower scores indicate a better quality of life. | Change from baseline at 12 weeks |
| Adverse Events | Adverse events related with the treatment, referred by patients, caregivers or health professionals | Change from baseline at 4, 8 and 12 weeks |
| 17385590 | Background | Lazareth I, Ourabah Z, Senet P, Cartier H, Sauvadet A, Bohbot S. Evaluation of a new silver foam dressing in patients with critically colonised venous leg ulcers. J Wound Care. 2007 Mar;16(3):129-32. doi: 10.12968/jowc.2007.16.3.27015. |
| 20671048 | Background | Moore K, Hall V, Paull A, Morris T, Brown S, McCulloch D, Richardson MC, Harding KG. Surface bacteriology of venous leg ulcers and healing outcome. J Clin Pathol. 2010 Sep;63(9):830-4. doi: 10.1136/jcp.2010.077032. Epub 2010 Jul 29. |
| 26199888 | Background | Moore MF. Prospective, Descriptive Study of Critically Colonized Venous Leg Ulcers Managed With Silver Containing Absorbent Dressings and Compression. J Am Coll Clin Wound Spec. 2014 Sep 16;5(2):36-9. doi: 10.1016/j.jccw.2014.08.002. eCollection 2013 Aug. |
| 26833351 | Background | Pugliese DJ. Infection in Venous Leg Ulcers: Considerations for Optimal Management in the Elderly. Drugs Aging. 2016 Feb;33(2):87-96. doi: 10.1007/s40266-016-0343-8. |
| 28277989 | Background | Totty JP, Bua N, Smith GE, Harwood AE, Carradice D, Wallace T, Chetter IC. Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: a systematic review. J Wound Care. 2017 Mar 2;26(3):107-114. doi: 10.12968/jowc.2017.26.3.107. |
| 25879267 | Background | Wendelken ME, Berg WT, Lichtenstein P, Markowitz L, Comfort C, Alvarez OM. Wounds measured from digital photographs using photodigital planimetry software: validation and rater reliability. Wounds. 2011 Sep;23(9):267-75. |
| Background | González-Consuegra, R.V., Verdú, J., 2010. Proceso de adaptación al castellano del Charing Cross Venous Ulcer Questionnaire (CCVUQ) para medir la calidad de vida relacionada con la salud en pacientes con úlceras venosas. Gerokomos 21, 80-87 |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014947 | Wounds and Injuries |