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

Skin Graft Complications Clinical Trial

— OASIS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02994589
• Other study ID #: 5150267
• Status: Withdrawn
• Phase: Phase 4
• First received: August 31, 2015
• Last updated: December 13, 2016
• Start date: October 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Graft Complications

Intervention

Other:
• Tegaderm™(Absorbant, 3M)
3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.

Device:
• 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).

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

References & Publications (4)

Eskes AM, Brölmann 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. — View 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. — View 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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Aesthetic Outcome	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.	1-12 weeks	No
Secondary	Pain intensity measure	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)	7 days	No