Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds

NCT00479193 | Withdrawn Phase 1

• 1 other identifier: Investigator Initiated Trial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Burns; Dressing change

Outcome Measures

Primary Outcomes (1)

• Time to wound healing

  21 days

Secondary Outcomes (1)

• Comparing two FDA cleared products for decreased frequency of dressing changes to every third day, less pain, decrease in infection, and cost effectiveness.

  21 days

Study Arms (1)

1

OTHER

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; Drug: Polymem

Interventions

bacitracin/xeroform DRUG

single layer, change every 3 days

1

Polymem DRUG

single layer of Polymen, change every 3 days

Also known as: No other names

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age under 18
• Burn injury over 48 hours old
• Deep burn not expected to heal within 21 days
• Extremely superficial burn expected to heal in less than 7 days.
• Infected burns
• Patient unable to return to clinic for required follow-up (i.e. will use visiting nurse or PCP for follow-up).
• Patient unable to give consent.
• Inpatient

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (4)

• Carr RD, Lalagos DE. Clinical evaluation of a polymeric membrane dressing in the treatment of pressure ulcers. Decubitus. 1990 Aug;3(3):38-42.

  PMID: 2205233 BACKGROUND

• 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.

  PMID: 8996261 BACKGROUND

• 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.

  PMID: 1878118 BACKGROUND

• 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.

  PMID: 8026290 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Bacitracin; 2,4,6-tribromophenol; Polymem

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Charles Yowler, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Trauma Burns Surgery

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: October 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 11, 2017

Record last verified: 2017-08

Locations

US (1)