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Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds

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ClinicalTrials.gov Identifier: NCT00479193
Recruitment Status : Withdrawn
First Posted : May 28, 2007
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Charles J. Yowler MD, MetroHealth Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Burns Drug: bacitracin/xeroform Drug: Polymem Phase 1

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Polymem vs. Bacitracin/Xeroform for Superficial Second Degree Burns
Estimated Study Start Date : October 2006
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
1
There is one arm to the study. The same subjects are their own control. 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 )]. 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. 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.The study will end for each patient when the investigator determines that 95% of their burn has re-epithelized.
 Drug: bacitracin/xeroform
single layer, change every 3 days

Drug: Polymem
single layer of Polymen, change every 3 days
Other Name: No other names


Outcome Measures
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Primary Outcome Measures :
  1. Time to wound healing [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479193


Locations
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United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
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Principal Investigator: Charles Yowler, MD MetroHealth Medical Center
More Information
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Publications:

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Responsible Party: Charles J. Yowler MD, Doctor of Trauma Burns Surgery, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00479193    
Other Study ID Numbers: Investigator Initiated Trial
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: August 2017
Keywords provided by Charles J. Yowler MD, MetroHealth Medical Center:
Burns
Dressing change
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Bacitracin
 Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents