A Phase 1 interventional study of bacitracin/xeroform and Polymem in Burns, sponsored by MetroHealth Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by MetroHealth Medical Center · Phase 1, Interventional, and Treatment
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
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Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
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Exclusion Criteria:
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
single layer, change every 3 days
single layer of Polymen, change every 3 days
Also known as: No other names
Time to wound healing
Time frame: 21 days
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
This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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