Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: May 25, 2007
• First Posted Date: May 28, 2007
• Last Update Posted Date: September 11, 2017
• Estimated Study Start Date: October 2006
• Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 25, 2007): Time to wound healing [ Time Frame: 21 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 25, 2007): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds
• Official Title: Prospective Randomized Trial of Polymem vs. Bacitracin/Xeroform for Superficial Second Degree Burns

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.

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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Burns

Intervention

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

Study Arms

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.

Interventions:

• Drug: bacitracin/xeroform
• Drug: Polymem

Publications *

• Carr RD, Lalagos DE. Clinical evaluation of a polymeric membrane dressing in the treatment of pressure ulcers. Decubitus. 1990 Aug;3(3):38-42.
• Agren MS, Mertz PM, Franzen L. A comparative study of three occlusive dressings in the treatment of full-thickness wounds in pigs. J Am Acad Dermatol. 1997 Jan;36(1):53-8. doi: 10.1016/s0190-9622(97)70325-6.
• Fowler E, Papen JC. Clinical evaluation of a polymeric membrane dressing in the treatment of dermal ulcers. Ostomy Wound Manage. 1991 Jul-Aug;35:35-8, 40-4. No abstract available.
• Blackman JD, Senseng D, Quinn L, Mazzone T. Clinical evaluation of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers. Diabetes Care. 1994 Apr;17(4):322-5. doi: 10.2337/diacare.17.4.322.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: August 28, 2017): 0
• Original Estimated Enrollment (submitted: May 25, 2007): 100
• Estimated Study Completion Date: December 2008
• Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00479193
• Other Study ID Numbers: Investigator Initiated Trial
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Charles J. Yowler MD, MetroHealth Medical Center
• Original Responsible Party: Not Provided
• Current Study Sponsor: MetroHealth Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Charles Yowler, MD; MetroHealth Medical Center

• PRS Account: MetroHealth Medical Center
• Verification Date: August 2017