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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Exciton Technologies Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
Epidemiology Coordinating and Research (EPICORE) Centre
Smart Clinical Research Inc.
Information provided by:
Exciton Technologies Inc.
ClinicalTrials.gov Identifier:
NCT00968994
First received: August 27, 2009
Last updated: December 22, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Wound Healing
Wound Infection
Device: The exSALT™ SD7 Wound Dressing
Device: Xeroform® Petrolatum Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Site-Matched, Controlled Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites

Resource links provided by NLM:


Further study details as provided by Exciton Technologies Inc.:

Primary Outcome Measures:
  • Evaluate the proportion of donor sites healed. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Evaluate the proportion of donor sites healed. [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to re-epithelialization. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pain with dressing changes and mobilization. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Assessments that quantify ease of use. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Resource utilization and safety. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Appearance and long term cosmetic results. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
Other Name: K083870
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.
Device: Xeroform® Petrolatum Dressing
Sterile, single use, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend.
Other Name: K973507

Detailed Description:

Autologous skin grafting is a common procedure required in the care of burn and plastic surgery patients where the harvesting of autologous skin grafts results in the creation of a partial thickness wound known as a donor site. The donor site healing time can affect the length of hospitalization and subject survival.

The literature reports the use of a variety of donor site dressing materials including fine mesh gauze, polyurethane film, synthetic fiber and hydrocolloids (Kilinc, Sensoz et al. 2001). The literature reports what might be considered the optimal donor site dressing attributes. These attributes would include: minimizing pain, velocity in healing, minimizing bacterial growth and simplicity in use (Rakel, Bermel et al. 1998).

However, none of the available dressing products are entirely satisfactory. Fine mesh gauze (FMG) is the donor site dressing used at many burn centers, as it is inexpensive, can be placed on posterior donor sites, does not require a margin of intact skin and allows large amounts of exudate to drain away from the donor site.

However, FMG does not have any inherent anti-infective properties and provides a dry environment for wound healing. Xeroform® Petrolatum Dressing resembles FMG physically except that it contains 3% xeroform (bismuth tribromophenate) which exerts some antibacterial effect (Feldman, Rogers et al. 1991). Xeroform® Petrolatum Dressing is the standard donor site dressing in the Firefighters' Burn Treatment Unit (3C2 WMC) and Plastic Surgery Unit (3D3 WMC) and has been selected as the control treatment (Control Dressing).

Research evidence demonstrates that partial thickness wounds re-epithelialize more rapidly in a moist environment that is free from infection (Alper 1986; Alvarez 1988). In an effort to provide an improved method of dressing wounds and donor sites, exSALT SD7™ has been proposed as an alternative dressing (Test Dressing). The dressing is intended to reduce pain and discomfort and improve the re-epithelialization process by providing a moist environment. The model outlined in this protocol provides the basis for a controlled comparison of wound healing and re-epithelialization in a clean partial thickness wound that allows us to compare the healing rate and quality of the Test Dressing compared to our standard of care to determine safety and efficacy.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968994

Contacts
Contact: John Simon, BSc 780-248-5884 JSimon@Excitontech.com
Contact: Heather Shankowsky, RN 780-407-3408 Heather.Shankowsky@albertahealthservices.ca

Locations
Canada, Alberta
The University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Heather Shankowsky, RN    780-407-3408    Heather.Shankowsky@albertahealthservices.ca   
Contact: Edward E Tredget, MD, MSC    780-407-6979    etredget@ualberta.ca   
Principal Investigator: Edward E Tredget, MD, MSc         
Sub-Investigator: Timothy M Riegel, MD         
Sponsors and Collaborators
Exciton Technologies Inc.
Alberta Heritage Foundation for Medical Research
Epidemiology Coordinating and Research (EPICORE) Centre
Smart Clinical Research Inc.
Investigators
Study Director: Ruth Collins-Nakai, MD, MBA Exciton Technologies Inc.
Principal Investigator: Edward E Tredget, MD, MSc University of Alberta
  More Information

No publications provided

Responsible Party: Mr. Rod Precht / President & COO, Exciton Technologies Inc.
ClinicalTrials.gov Identifier: NCT00968994     History of Changes
Other Study ID Numbers: PR-0004
Study First Received: August 27, 2009
Last Updated: December 22, 2009
Health Authority: Canada: Health Canada

Keywords provided by Exciton Technologies Inc.:
Wound Healing
Wound Infection

Additional relevant MeSH terms:
Wound Infection
Infection
Wounds and Injuries
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014