BurnsPhase 1NCT00479193
Polymem vs. Bacitracin/Xeroform in Treating Burn Wounds
A Phase 1 study testing bacitracin/xeroform and Polymem in people with Burns, run by MetroHealth Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- bacitracin/xeroform and Polymem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns
- Being tested
- bacitracin/xeroform, Polymem
- Keywords
- Burns, Dressing change
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacitracin/xeroformDrug
single layer, change every 3 days
PolymemDrug
Also called No other names
single layer of Polymen, change every 3 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: bacitracin/xeroform; Drug: Polymem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to wound healing
Measured: 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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startOct 2006 (estimated)
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles J. Yowler MD, MetroHealth Medical Center
- Investigators
- Charles Yowler, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479193
- Sponsor's protocol ID
- Investigator Initiated Trial
- Status last verified
- Aug 2017
- First submitted
- 25 May 2007
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 2205233Agren 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.
PubMed 8996261Fowler 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.
PubMed 1878118Blackman 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.
PubMed 8026290
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Polymem vs. Bacitracin/Xeroform for Superficial Second Degree Burns
- ClinicalTrials.gov ID
- NCT00479193
- Acronym / sponsor ID
- Investigator Initiated Trial
- Conditions
- Burns
- Keywords
- Burns, Dressing change
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- Oct 2006 (estimated)
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 28 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: bacitracin/xeroform, Drug: PolymemThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bacitracin/xeroformsingle layer, change every 3 days | Drug | 1 |
| PolymemAlso: No other namessingle layer of Polymen, change every 3 days | Drug | 1 |
Primary outcome
Time to wound healing
Time frame: 21 days
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Background: PubMed 2205233Carr RD, Lalagos DE. Clinical evaluation of a polymeric membrane dressing in the treatment of pressure ulcers. Decubitus. 1990 Aug;3(3):38-42.
- Background: PubMed 8996261Agren 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.
- Background: PubMed 1878118Fowler 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.
- Background: PubMed 8026290Blackman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Yowler, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bacitracin/xeroform and Polymem in people with Burns, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to wound healing (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00479193, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.