Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01668030 |
| Other study ID # |
11.0456 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
August 8, 2012 |
| Last updated |
August 16, 2012 |
| Start date |
April 2012 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
August 2012 |
| Source |
University of Louisville |
| Contact |
Carlee Lehna, PhD |
| Phone |
502-290-7254 |
| Email |
c0lehn01[@]louisville.edu |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
Forty percent of patients admitted to the contributing regional burn unit over a five month
period received facial burns (n=14). The purpose of this study is to examine if the time
until a granulation bed is well established can be decreased be using an enzymatic agent,
when compared to a second standard ointment, for patients with partial-thickness facial
burns. The current study will use a prospective, experimental study design in which each
individual will be their own matched control. That is, each individual will receive both the
experimental ointment (one-side of the face) and the standard ointment (other-side of the
face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation
bed establishment) one ointment achieves in partial-thickness facial burns when compared to
a second ointment. Exploratory analyses will examine the relationships among demographic
variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That
is, testing whether the time until granulation establishment may be associated with an
individual's demographic variables, treatment type, pain, anxiety, itching levels, and
scarring. Significance for all analysis will be at the 0.05 level. The investigators
hypothesize that promoting rapid granulation bed establishment will decrease hospital length
of stays, costs, risk of infection, and possibly associated appearance changes. The results
from the current study will provide preliminary findings for a future, more sophisticated
study.
Description:
Rapid wound healing in burn injuries advances wound closure, and decreases opportunities for
infection and scarring (Hansbrough, Achauer, Dawson, et al., 1995; Soroff & Sasvary, 1994);
also leading to a shorter length of stays (LOS). Decreased LOS in the hospital supported by
rapid wound closure facilitates reentry to the home and work environments should lead to a
reduction in the costs associated with hospitalization. In addition, for patients with
facial burns, rapid granulation bed establishment may decrease associated appearance
changes.
Use of an enzymatic agent has been described in only three studies (Hansbrough, Achauer,
Dawson, et al., 1995; Soroff & Sasvary, 1994; Varma, Bugatch, & German 1973). Treatment an
enzymatic agent resulted in shorter time to achieve a clean wound bed and significantly more
rapid wound healing when compared to controls or other agents for 94 patients with
non-facial, partial-thickness burns (Hansbrough, Achauer, Dawson, et al.; Soroff & Sasvary).
Twenty patients with dermal ulcers treated with an enzmatic agent, when compared to placebo
controls, showed significantly decreased pus, odor, necrosis, and inflammation (Varma,
Bugatch, & German, 1973). There was a relative reduction in wound size almost reaching
significance (p<0.07) for those patients with dermal ulcers too.
Though an enzymatic agent is without purported antibiotic properties, a rapid reduction in
bacterial burden in wounds has been shown in animal models (Payne, Salas, Ko, Naidu, Donate,
Wright et al., 2008). The bacterial burden decreased rapidly in scald burn wounds to achieve
a bacterial balance for 15 rats with E-coli infected wounds when compared with
saline-treated controls to <105 colony forming units/gram of tissue (p < .05).
Previous studies have suggested that the exploratory variables being collected are
associated with shorter healing times and lower infection rates. Whether these differences
are actually due to some other mediating/moderating factor (gender-specific enzyme or
hormone concentrations, gene interaction, metabolism, etc) and not the exploratory variables
is unclear and not empirically established. A future, larger study will hopefully more fully
explore these relationships. However, to justify the more detailed investigations will
require showing differences at the more crude level. Unfortunately, to date there has been
no research examining the potential benefits of using collagenase in patients with facial
burn injuries. As a result, the aims of this study are to:
1. Show the benefit (e.g., decreased time until the granulation bed is well established,
shorter time until wound closure) an enzymatic agent achieves in partial-thickness
facial burns when compared to a common antibacterial agent;
2. Investigate the interrelationships among demographic variables, treatment, pain,
anxiety, and itch;
3. Explore whether time to granulation bed establishment can be predicted from treatment;
when adjusting for demographic variables, pain, anxiety, and itch levels.
4. Examine the long-term scarring and social experience of persons with facial burns.
Design: A prospective, experimental study design in which each individual will be their own
matched control.
Methods
Procedure. Within 24 hours of burn unit admission, patients or their spouses, or guardians
will be asked regarding study participation. Upon patient agreement, and signing the
institutional review board approved informed consent form, HIPAA Research Authorization, a
demographic information form will be completed and wound culture results obtained (if
ordered).
The patients will be randomized into receiving either bacitracin or collagenase to the right
side of the face (ointment one). Ointment two will be applied to the left side of the face.
Treatment of the partial-thickness facial burns will be performed by the nurses on the burn
unit according to burn unit protocol. Therefore, each person will serve as their own matched
control, thus reducing the sample size required to achieve sufficient power for the study by
reducing deviance between cases and control (i.e., age, pain, itch, size of burn, and
scarring). Also, this type of study design will allow us to achieve valid, reliable results
with fewer individuals. This is a typical study design for similar ointment and eye drops
studies. The bridge of the nose will be used as a guide to divide the face in half
lengthwise. The wound will be cleansed and dressed twice daily. Treatment will continue
until the granulation bed is well established. Daily ratings of pain, anxiety, and itch will
be obtained at each morning dressing change. Digital photographs of only the facial burn
will be taken weekly and at the first outpatient visit.
Patient confidentiality will be maintained by assigning participants a random, unique, study
identification number that cannot be linked directly to any individual. This random number
will be used in all study data sets for data management and data analysis. Signed (approved)
informed consent forms will be kept in a locked file in the principle investigator's office.
The research data sets will be stored on a university secured computer drive.
Digital photographs will be identified by patient number. These photographs will be rated by
burn wound experts recruited from a posting on the American Burn Association web site (e.g.
nurses and/or physical therapists certified in wound care with a minimum of 5 years'
experience). Patients' records will also be assessed weekly as to whether any patient on
study has a wound or blood infection confirmed by a positive laboratory culture. Those
patients with confirmed positive cultures will be dropped from the study. Patient pain,
anxiety, and itch scoring will be obtained and recorded by the nurses caring for patients on
the burn unit.
Assessment of scarring will be obtained at the first out-patient visit by both the
healthcare provider and patient. For the three and six month follow-ups, every effort will
be made to have both the health care provider and patient assessments, however, it may not
always be possible to have the patient return to the hospital (e.g., costs associated with
travel and missing work) so the patient's assessment will be obtained via telephone.
Assessment of the social experience will be obtained by completing the two instruments and
open-ended questions either in-person or through a telephone interview at the first
out-patient visit, at three and six months after injury.
Instrumentation
Pain and Anxiety. Physician ordered analgesic and anxiety therapy will be provided per
patient request prior to each dressing change. At each morning dressing change, patients
will rate their perception of pain and anxiety, separately, with a 10-point visual analogue
scale (where 1= no pain, or anxiety and 10= the most possible) at three time points. These
times will be: prior to cleansing and debridement, at completion of the dressing change, and
30 minutes after treatment. The Richmond Agitation and Sedation Scale (RASS) will be used
with non-verbal patients.
Richmond Agitation and Sedation Scale (RASS). Inter-rater reliability in 290-paired
observations by nurses, results of both the RASS demonstrated excellent inter-rater
reliability (weighted kappa, 0.91 and 0.94, respectively) (Ely, Truman, Shintani, et al.,
2003). Criterion validity was tested in 411-paired observations in the first 96 patients of
the validation cohort, in whom the RAS showed significant differences between levels of
consciousness (P<.001 for all) and correctly identified fluctuations within patients over
time (P<.001). Face validity was demonstrated via a survey of 26 critical care nurses, which
the results showed that 92% agreed or strongly agreed with the RASS scoring scheme, and 81%
agreed or strongly agreed that the instrument provided a consensus for goal-directed
delivery of medications.
Itch. Physician ordered itch therapy (e.g., Benadryl, Atarax, or Claritin) will be provided
per patient request prior to each dressing change. At each morning dressing change, patients
will rate their perception of itch with a 10-point visual analogue scale (where 1=no itch
and 10=the most possible), at three time points. These times will be: prior to cleansing and
debridement, at completion of the dressing change, and 30 minutes after treatment.
Scarring. Scarring will be measured by two instruments [The Patient and Observer Scar
Assessment Scale (POSAS)] developed by Draaijers, Tempelman, Botman, et al. (2004) and
further tested by Van de kar, Corion, Smeulders, et al. (2005. These two instruments, one
for the health care provider and the second for the patient, recognizes the need for both
the professional's and patient-based need for scar assessment, whereas, the Vancouver Scar
Scale (VSS) only assesses scar severity from the professional's viewpoint. Though the VSS
has been accepted and used as a scar assessment tool, there is not evidence to suggest it is
the "gold standard" measure of burns scarring, and additionally, it does not include the
patient's perception of their scarring.
The POSAS has items assessing vascularity, pigmentation, thickness, relief and pliability,
rated on a 10-point numeric scale, with normal skin and worst scar used as end labels. Items
on the patient scale directly correspond to theses except for scar color. Patients are asked
to rate their itchiness and scar pain. A ten-point numeric scale is used (1=no complaints
/normal skin, 10=worst imaginable/very different). Individual items are summed with higher
scores representing poorer scars and lower scores representing scars more closely to normal
skin. Both scales showed acceptable internal consistency (Cronbach's alpha 0.76 (patient)
and 0.69 (observer). The test-retest reliability of the patient scale has not been evaluated
in burn scars.
Social Experience. It is proposed that partial-thickness burns to both sides of the face
result in non-normal appearance which may cause stigmatizing and dehumanizing behavior
directed at these burn survivors (Lawrence, Fauerbach, Heinberg, Doctor, and Thombs, 2006;
Lawrence, Rosenberg, Rimmer, Tombs, and Fauerbach, 2010). The following two instruments will
assess the social experience.
The social experience will be measured by two instruments: the Perceived Stigmatization
Questionnaire (PSQ) and the Social Comfort Questionnaire (SCQ) (Lawrence, Fauerbach,
Heinberg, Doctor, and Thombs, 2006; Lawrence, Rosenberg, Rimmer, Tombs, and Fauerbach,
2010). Both instruments were developed and tested for use with a population of burn injury
survivors. The PQS is a 21 item scale where each item is measured on a 5-point Likert scale
(never, almost never, sometimes, often, always). Three factors were loaded: absence of
friendly behavior, confused behavior and starring, and hostile behavior. Scores are
calculated by totaling items and dividing by 21. Higher scores indicate levels of perceived
stigmatizing behaviors.
The SCQ is an eight item, one factor scale. Each item is also measured on a 5-point Likert
scale (never, almost never, sometimes, often, always). The final score is the average of
items; higher scores indicate higher social comfort.
Open-ended Questions: Several open-ended questions will be included to allow participants to
describe instances of how their social experience changed after the facial burn injury. It
is hoped that these answers will further clarify the two instrument findings
