A Comparison of OASIS Wound Matrix With Approved Dressings for Skin Graft Donor Sites
NCT ID: NCT02994589
Last Updated: 2016-12-16
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-10-31
2016-12-31
Brief Summary
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Detailed Description
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Patients will be randomly assigned to one of the three treatment groups and followed up post-operatively and treated as per current standard of care.
Data to be collected and analyzed includes: patient age, co-morbid illnesses, medication, skin-graft donor location, skin-graft donor area, STSG thickness, infection rate, complications involving the donor site, post-operative pain score every morning until hospital discharge, healing rate, photographs of the donor site immediately post-operatively and then at routine follow-up appointments.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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OASIS® wound matrix
OASIS wound matrix is a biologic extracellular matrix derived from porcine small intestine submucosa. Some components of OASIS wound matrix are similar to human dermis including types of collagens, elastin, glycoproteins and proteoglycans. In addition, OASIS wound matrix retains some growth factors that have been suggested to aid in the wound healing process. It is a FDA approved wound dressing indicated for use in a variety of ulcers, abrasions and surgical wounds.
OASIS® wound matrix
OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).
Tegaderm™(Absorbant, 3M)
Transparent dressing allows for wound monitoring without changing the dressing Clear design takes the guesswork out of application over the wound Novel acrylic polymer pad technology designed to handle low to moderate wound drainage. No dressing breakdown in the wound. Low friction surface minimizes potential for friction and shear. Allows for gentle removal from skin. Barrier to external contaminants, body fluids, bacteria and viruses.
Tegaderm™(Absorbant, 3M)
3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.
Xeroform™
Xeroform™ Occlusive Petrolatum Gauze. 3% Bismuth Tribromophenate in a special petrolatum blend on fine mesh gauze. Non-adherent. Clings and conforms to all body contours.
Xeroform™
Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.
Interventions
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Tegaderm™(Absorbant, 3M)
3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.
OASIS® wound matrix
OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).
Xeroform™
Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.
Eligibility Criteria
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Inclusion Criteria
* patients able to consent without a proxy
Exclusion Criteria
* previous skin grafting from site
* prior use of biological skin substitute on site
18 Years
80 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Subhas Gupta, MD, PhD
Role: STUDY_CHAIR
Loma Linda University
Hahns Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
References
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Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venus Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005 May;41(5):837-43. doi: 10.1016/j.jvs.2005.01.042.
Hankin CS, Knispel J, Lopes M, Bronstone A, Maus E. Clinical and cost efficacy of advanced wound care matrices for venous ulcers. J Manag Care Pharm. 2012 Jun;18(5):375-84. doi: 10.18553/jmcp.2012.18.5.375.
Eskes AM, Brolmann FE, Gerbens LA, Ubbink DT, Vermeulen H; REMBRANDT study group. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial. Trials. 2011 Oct 17;12:229. doi: 10.1186/1745-6215-12-229.
Fernandes de Carvalho V, Paggiaro AO, Isaac C, Gringlas J, Ferreira MC. Clinical trial comparing 3 different wound dressings for the management of partial-thickness skin graft donor sites. J Wound Ostomy Continence Nurs. 2011 Nov-Dec;38(6):643-7. doi: 10.1097/WON.0b013e3182349d2f.
Other Identifiers
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5150267
Identifier Type: -
Identifier Source: org_study_id