Clinical trial NCT02994589: A Comparison of OASIS Wound Matrix With Approved Dressings for Skin Graft Donor Sites
Official title: A Comparison of OASIS Wound Matrix With Approved Dressings for Split Thickness Skin Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Skin Graft Complications
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The investigators objective is to compare OASIS wound matrix with other commonly used dressings available for the donor site in split thickness skin grafting in order to determine which dressing provides the best outcome based on pain level, time to healing and aesthetic outcome.

Detailed description: Investigators seek to compare Oasis wound matrix with Tegaderm and Xeroform in order to determine whether advantages exist in one or more of the dressing types that are approved and currently used for split-thickness skin graft donor site dressings.

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.

Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo split thickness skin grafting
* patients able to consent without a proxy

Exclusion Criteria:

* confounding medical conditions
* previous skin grafting from site
* prior use of biological skin substitute on site

Primary outcomes:
measure: Time to Heal
timeFrame: 7-21 days
Secondary outcomes:
measure: Aesthetic Outcome
timeFrame: 1-12 weeks
measure: Pain intensity measure
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University
name: Subhas Gupta, MD, PhD
role: STUDY_CHAIR
affiliation: Loma Linda University
name: Hahns Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.