Recruiting

exSALT SD7™ vs. Xeroform®

Sponsor:

Exciton Technologies Inc.

Code:

NCT00968994

Conditions

Wound Healing

Wound Infection

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

The exSALT™ SD7 Wound Dressing

Xeroform® Petrolatum Dressing

Study Details

Brief 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

Study ID

NCT00968994

Start date

Dec, 2009

Status verified date

Dec, 2009

Completion date

Jan, 2011

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • signed or verbal informed consent provided
  • are 18 to 65 years of age
  • scheduled to undergo a split-thickness skin graft (autograft) that will result in a donor site or sites that are; a first time harvest and includes primarily the anterior including medial and lateral aspects of the anterior portion(s) of the thigh(s) with either; a single donor site that is a minimum of 8 x 20 cm or two donor sites are both a minimum of 8 x 8 cm and the resulting test sites are generally comparable in size and wound characteristics.
  • requires hospitalization for initial treatment

Exclusion Criteria:

  • require full thickness graft
  • known skin sensitivity to any of the dressing components
  • poor prognosis and who are unlikely to survive the trial period
  • participating in another concurrent trial
  • exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: exSALT SD7™ Wound Dressing

The exSALT™ SD7 Wound Dressing provides an antimicrobial barrier that inhibits microbial growth in the dressing. The exSALT™ SD7 Wound Dressing consists of 3 layers: two non-adherent polyethylene mesh wound contact layers and one absorbent core made of polyester. All three layers are silver coated. The concentration of silver on the exSALT™ SD7 Wound Dressing is approximately 0.4 mg/cm2 (2.5% w/w).

active comparator: Xeroform® Petrolatum Dressing

Xeroform® Petrolatum Dressing (Xeroform® / Control Dressing) is fine mesh gauze impregnated with 3% Bismuth Tribromophenate in a special petrolatum blend. The dressing is a non adherent dressing that clings and conforms to all body parts.

Interventions

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.

Xeroform® Petrolatum Dressing

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

Primary outcome measure

  • Evaluate the proportion of donor sites healed. [ Time Frame: 10 days ]
  • Evaluate the proportion of donor sites healed. [ Time Frame: 14 Days ]

Central Contacts and Locations

Central contacts

John Simon, BSc

780-248-5884JSimon@Excitontech.com

Heather Shankowsky, RN

780-407-3408Heather.Shankowsky@albertahealthservices.ca

Locations

The University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Heather Shankowsky, RN

780-407-3408Heather.Shankowsky@albertahealthservices.ca

Edward E Tredget, MD, MSC

780-407-6979etredget@ualberta.ca

Principal Investigator:

Edward E Tredget, MD, MSc

More Information

Sponsor

Exciton Technologies Inc.

Last update posted

Dec 24, 2009

Last verified

Dec, 2009

Keywords

  • Wound Healing
  • Wound Infection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Exciton Technologies Inc. on 2009-12-24.