A Comparison of OASIS Wound Matrix With Approved Dressings for Skin Graft Donor Sites

NCT02994589 — Phase 4, Withdrawn, Loma Linda University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Comparison of OASIS Wound Matrix With Approved Dressings for Split Thickness Skin Graft Donor Sites

Registry	NCT02994589, acronym OASIS
Status	Withdrawn - Study was never started
Phase	Phase 4
Study type	Interventional; randomized, factorial, masking: single, treatment
Sponsor	Loma Linda University (Other)
Conditions	Skin Graft Complications
Interventions	Tegaderm™(Absorbant, 3M), OASIS® wound matrix, Xeroform™ (Other, device)
Dates	start 2016-10-01, primary completion 2016-12-01, completion 2016-12-01, first posted 2016-12-16, last updated 2016-12-16

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
OASIS® wound matrix	Experimental	Device: 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.
Tegaderm™(Absorbant, 3M)	Active comparator	Other: 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.
Xeroform™	Active comparator	Other: 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.

Tegaderm™(Absorbant, 3M) (Other): 3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.
OASIS® wound matrix (Device): 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™ (Other): Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.

+Outcome measures

Primary outcomes

Time to Heal [7-21 days]: Patient will be followed up during routine post-operative appointments at the clinic weekly to check the healing process of the donor site wound.

Secondary outcomes

Aesthetic Outcome [1-12 weeks]: During routine followup visits to the clinic, the donor site aesthetic outcome will be observed and recorded clinically and digitally (photographs). The Vancouver Scar Scale will be used.
Pain intensity measure [7 days]: Self reported pain intensity in the morning and evening with activity over the past 7 days. Each item is scored on a scale of 0-10 (0= no pain, 10= highest intensity of pain)

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Publications

Results publication: 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. PMID 15886669
Results publication: 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. PMID 22663170
Results publication: 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. PMID 21999705
Results publication: 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. PMID 22011820

+Investigators

Subhas Gupta, MD, PhD, Study chair, Loma Linda University
Hahns Kim, MD, Principal investigator, Loma Linda University