A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
NCT ID: NCT05608317
Last Updated: 2024-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-11-08
2024-11-30
Brief Summary
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Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
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Detailed Description
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There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care with Non-Bordered Foam Dressing
All Subjects will use a non-bordered foam dressing as the absorbent primary dressing.
ALLEVYN Non-Adhesive
ALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction.
ALLEVYN Non-Adhesive consists of the following layers:
* Breathable top film
* Highly absorbent foam core
* Non-adhesive wound contact layer
Interventions
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ALLEVYN Non-Adhesive
ALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction.
ALLEVYN Non-Adhesive consists of the following layers:
* Breathable top film
* Highly absorbent foam core
* Non-adhesive wound contact layer
Eligibility Criteria
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Inclusion Criteria
* Adult aged ≥18 years
* Diagnosed with a chronic, exuding VLU
* Exudate amount moderate to large
* Wound size from 3 cm2 to 30 cm2, as determined by the clinician
* ABPI (within 3 months) \> 0.7. If ABPI \> 1.4, then big toe pressure \> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
* Willing to be compliant with compression therapy
Exclusion Criteria
* Circumferential wound
* Known allergy/hypersensitivity to the materials of the dressing
* Use of wound fillers
18 Years
ALL
No
Sponsors
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Molnlycke Health Care AB
INDUSTRY
Responsible Party
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Principal Investigators
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Hadar Lev-Tov, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Center for Clinical Trials, Inc.
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney J, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. Wound Repair Regen. 2015 Jan-Feb;23(1):1-13. doi: 10.1111/wrr.12245. Epub 2015 Feb 13.
Rippon M WM, Bielfeldt S. An evaluation of properties related to wear time of four dressings during a five-day period. Wounds UK. 2015;11(1):45-54.
Tickle J. Wound exudate: a survey of current understanding and clinical competency. Br J Nurs. 2016 Jan 28-Feb 10;25(2):102-9. doi: 10.12968/bjon.2016.25.2.102.
Young T, Clark M, Augustin M, Carville K, Curran J, Flour M, et al. International consensus. Optimising wellbeing in people living with a wound. An expert working group review. Wounds International; London 2012.
Chadwick P, McCardle J. Exudate management using a gelling fibre dressing. The Diabetic Foot Journal. 2015;18(1):43-8.
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.
Jones JE, Robinson J, Barr W, Carlisle C. Impact of exudate and odour from chronic venous leg ulceration. Nurs Stand. 2008 Jul 16-22;22(45):53-4, 56, 58 passim. doi: 10.7748/ns2008.07.22.45.53.c6592.
World Union of Wound Healing Societies (WUWHS). Principles of best practice: Wound exudate and the role of dressings. A consensus document. 2019.
European Wound Management Association (EWMA). Position document: Wound bed preparation in practice. London: MEP Ltd. 2004.
Romanelli M, Vowden K, Weir D. Exudate Management Made Easy Wounds International 2010.
Walker M, Parsons D. Hydrofiber® technology: its role in exudate management. Wounds UK; 2010. p. 31-38.
Maume S, Van De Looverbosch D, Heyman H, Romanelli M, Ciangherotti A, Charpin S. A study to compare a new self-adherent soft silicone dressing with a self-adherent polymer dressing in stage II pressure ulcers. Ostomy Wound Manage. 2003 Sep;49(9):44-51.
Moore Z, Strapp H. Managing the problem of excess exudate. Br J Nurs. 2015 Aug 13-Sep 19;24(15):S12, S14-7. doi: 10.12968/bjon.2015.24.Sup15.S12.
Rippon M, Davies P, White R. Taking the trauma out of wound care: the importance of undisturbed healing. J Wound Care. 2012 Aug;21(8):359-60, 362, 364-8. doi: 10.12968/jowc.2012.21.8.359.
ALLEVYN Non-Adhesive. Advanced Wound Management <www.smith-nephew.com>. Accessed 2022 Apr 23.
Gorin DR, Cordts PR, LaMorte WW, Manzoian JO. The influence of wound geometry on the measurement of wound healing rates in clinical trials. J Vasc Surg. 1996 Mar;23(3):524-8. doi: 10.1016/s0741-5214(96)80021-8.
Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
Augustin M, Conde Montero E, Zander N, Baade K, Herberger K, Debus ES, Diener H, Neubert T, Blome C. Validity and feasibility of the wound-QoL questionnaire on health-related quality of life in chronic wounds. Wound Repair Regen. 2017 Sep;25(5):852-857. doi: 10.1111/wrr.12583. Epub 2017 Nov 2.
Other Identifiers
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DIPLO NBF
Identifier Type: -
Identifier Source: org_study_id
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