Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites

Summary

This randomized, controlled trial is designed to evaluate split-thickness donor sites treated with exSALT SD7™ compared to donor sites treated with Xeroform®. For the purpose of this study, subjects enrolled will have selected donor sites or portions of donor sites designated as "Test Sites." The selected locations will be randomly assigned treatment with either the Test Dressing or the Control Dressing.

The primary objective of the trial will be to quantify the proportion of the donor sites in each group that are healed at 10 and 14 days. Secondary objectives will include: time to re-epithelialization, pain with dressing changes and mobilization, ease of use, resource utilization and safety, as well as quality of healing and overall cosmetic result. A total of 25 subjects will be enrolled in the trial.

The trial duration will be 12 weeks. For the purposes of this trial, healing will be defined as ≥ 90% re-epithelialization and must be visually confirmed by the investigator or designate and two other people (i.e., research nurse, burn resident, member of the Wound Care Team). The maximum time to evaluate healing will be 14 days +/-2 days. A final visit will be conducted at 12 weeks for safety and to evaluate the quality of healing.

Conditions

• Wound Healing
• Wound Infection

Interventions

DEVICE

The exSALT™ SD7 Wound Dressing

The exSALT™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

DEVICE

Xeroform® Petrolatum Dressing

Sterile, single use, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend.

Sponsors & Collaborators

• Alberta Heritage Foundation for Medical Research

  collaborator OTHER

• Epidemiology Coordinating and Research Centre, Canada

  collaborator OTHER

• Smart Medical Research Inc.

  collaborator INDUSTRY

• Exciton Technologies Inc.

  lead INDUSTRY

Principal Investigators

• Ruth Collins-Nakai, MD, MBA · Exciton Technologies Inc.

• Edward E Tredget, MD, MSc · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2010-12-31

Completion

2011-01-31

Countries

• Canada

Study Locations