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

NCT02994589 | Withdrawn Phase 4

• 1 other identifier: 5150267
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Graft Complications

Outcome Measures

Primary Outcomes (1)

• Time to Heal

  Patient will be followed up during routine post-operative appointments at the clinic weekly to check the healing process of the donor site wound.

  7-21 days

Secondary Outcomes (2)

• Aesthetic Outcome

  1-12 weeks

• Pain intensity measure

  7 days

Study Arms (3)

OASIS® wound matrix

EXPERIMENTAL

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.

Device: OASIS® wound matrix

Tegaderm™(Absorbant, 3M)

ACTIVE COMPARATOR

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.

Other: Tegaderm™(Absorbant, 3M)

Xeroform™

ACTIVE COMPARATOR

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.

Other: Xeroform™

Interventions

Tegaderm™(Absorbant, 3M) OTHER

3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.

Tegaderm™(Absorbant, 3M)

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).

OASIS® wound matrix

Xeroform™ OTHER

Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.

Xeroform™

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Interventions

2,4,6-tribromophenol

Study Officials

• Subhas Gupta, MD, PhD

  Loma Linda University

  STUDY CHAIR

• Hahns Kim, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: December 16, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share