Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by MetroHealth Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00479193
First received: May 25, 2007
Last updated: January 24, 2008
Last verified: January 2008

May 25, 2007
January 24, 2008
October 2006
December 2008   (final data collection date for primary outcome measure)
Time to wound healing [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Time to wound healing [ Time Frame: 21 days ]
Complete list of historical versions of study NCT00479193 on ClinicalTrials.gov Archive Site
Comparing two FDA cleared products for decreased frequency of dressing changes to every third day, less pain, decrease in infection, and cost effectiveness. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Comparing two FDA cleared products for decreased frequency of dressing changes to every third day, less pain, decrease in infection, and cost effectiveness. [ Time Frame: 21 days ]
Not Provided
Not Provided
 
Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds
Prospective Randomized Trial of Polymem vs. Bacitracin/Xeroform for Superficial Second Degree Burns

Patients will be screened at the initial visit to the burn center. If the patients are eligible according to the inclusion/exclusion criteria, consent for the study will be obtained. One of the investigators will identify two sites that appear to be the same depth on each patient [1 site Polymen and 1 site bacitracin/xeroform )]. The depth of injury will be verified as partial thickness using laser doppler. Each site will be at least 4cm x 4cm in size. One site will be identified for bacitracin/xeroform and one site for Polymen. All burns will be initially debrided and cleaned according to burn unit protocol. The dressing will then be applied. All dressings will be covered with cotton gauze and ace wraps. Laser Doppler will be utilized to determine burn depth at both the trial and control sites. On each subsequent visit, patients will rate the pain of the dressing change on a 1-10 pain intensity scale. It will be noted if the wound appears infected or if antibiotics are prescribed.

The study will end for each patient when the investigator determines that 95% of their burn has re-epithelized.

Superficial second degree burns are limited to the epidermis and superficial layer of the dermis and are expected to heal without the need of surgery if they are treated appropriately. Complications such as desiccation of the wound or infection may extend the depth of the injury and result in an increase in scarring or the requirement for excision of the burn and skin grafting. The MetroHealth Burn Center treats over 1500 patients a year for superficial second degree burns.

Various methods are used from the conventional dressing methods using guaze to the methods that use biological materials such as skin from cadavers, pig's skin and artificial synthetic materials. Our present burn care involves initial superficial outpatient debridement of the burn wound and application of a dressing. This dressing consists of bacitracin applied to the burn wound and xeroform covered by cotton gauze and ace-wrap. The majority of our patients are unable to change this dressing by themselves and they either return to the burn center daily for wound care or we arrange for a visiting nurse.

Polymem is a novel dressing which has been approved by the FDA for open wounds including burns.Polymem is a hydrophilic polyurethane membrane pad with a semi permeable polyurethane film backing. The pad contains a wound cleanser (F68 surfactant), a moisturizer (glycerin) and an absorb ing agent (super-absorbent polymem). The F86 surfactant is involved in dissolving the superficial necrotic layer of the burn and helps clean the burn site. Glycerin acts as a moisturizer and prevents the pad from sticking to the wound. The absorbing agent maintains the moisture of the wound which has been shown to increase wound healing. It also allows the dressing to remain on the wound for three days. Kim et al conducted a study of 44 patients with second degree burns and demonstrated an increase in healing time, more comfort, and a decrease in dressing changes with the use of Polymem.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burns
  • Drug: Polymem
    single layer, change every 3 days
  • Drug: Polymem
    single layer of polymen, change every 3 days
    Other Name: No other names
1
There is one arm to the study. The same subjects are used for each level of the independent variable, they are their own controls.
Interventions:
  • Drug: Polymem
  • Drug: Polymem

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age + to or greater than 18
  2. Superficial 2nd degree burns of the trunk and extremities which the evaluating investigator believes will heal within 21 days without the need for surgery.
  3. Burn injury is less than 48 hours old
  4. Patient is able to return to burn clinic for required follow-up.
  5. Burn is of sufficient size to permit the application of trial and control dressings
  6. Outpatient

Exclusion Criteria:

  1. Age under 18
  2. Burn injury over 48 hours old
  3. Deep burn not expected to heal within 21 days
  4. Extremely superficial burn expected to heal in less than 7 days.
  5. Infected burns
  6. Patient unable to return to clinic for required follow-up (i.e. will use visiting nurse or PCP for follow-up).
  7. Patient unable to give consent.
  8. Inpatient
Both
18 Years and older
No
Contact: Charles Yowler, MD 216-778-5627 cyowler@metrohealth.org
Contact: Tammy Coffee, CNP 216-778-4899 tcoffee@metrohealth.org
United States
 
NCT00479193
Investigator Initiated Trial
No
Charles J. Yowler, MD, MetroHealth Medical Center
MetroHealth Medical Center
Not Provided
Principal Investigator: Charles Yowler, MD MetroHealth Medical Center
MetroHealth Medical Center
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP