Last modified: 10/26/06

NIDRR  Burn Model Systems Priorities and Galveston Studies


GOAL 1 / GOAL 2 / GOAL 3 / GOAL 4 / GOAL 5 / GOAL 6 /Future Directions
 

GOAL 1: Identify and evaluate techniques to prevent secondary complications of burn injury

   Study 1: Evaluation of the advantages of an intensive interdisciplinary inpatient rehabilitation program including resistance exercise in the functional outcomes of severely burned children and adolescents.

  Study 2: Long-term treatment of severely burned children with recombinant human growth hormone.

      These 2 studies together hypothesize that a catabolic state persists in burned children,
      extending into convalescence and causing significant burn complications, and that this
      response can be improved by resistance training and aerobic exercises alone or in
      combination with the anabolic agent, recombinant human growth hormone (rhGH).
      Clinical and functional outcomes  include lean body mass (TLBM), resting energy
      expenditure (REE), pulmonary function tests (PFT), cardio-pulmonary endurance,
      muscle strength, scar formation, bone density and histology of skin biopsies.
      The studies are progressing as anticipated and have achieved very exciting results to date.

      42 patients have been entered into the intensive exercise study, 20 in the No Exercise
      (NoEX) group and 22 in the Exercise (EX) group.  Preliminary results based
      on the endpoint of isokinetic leg strength, cardiovascular endurance, resting heart rate
      (as a reflection of training effect) and TLBM (as a reflection of muscle mass), suggest
      that exercise training (includes no rhGH and rhGH administration) is anabolic
      in burned children.

Preliminary results

ü      The EX group gained significantly more in terms of isokinetic strength, ability to
do muscle work and power than the NoEX group. Thus, although the mechanism
of anabolism has yet to be determined, exercise leads to an increase in muscle
strength after 12 weeks of exercise training, thus reflecting a decrease in the
catabolic response to burn injury.

ü      The change in cardiovascular endurance from 6 to 9 month for the EX group
is significant (21.3% vs 5.6% in the NoEX group), and reflects an improvement
in skeletal and cardiopulmonary endurance.

ü      Resting heart rate was decreased 22.0% in the EX group and 1.10% in the
NoEX group, reflecting an training effect.

ü      TLBM was also increased in the EX group (6.00%) vs the NoEX group (2.40%).

      The study of the utility of treatment with recombinant human growth hormone
      or a comparable anabolic agent also has had important results as follow:
 

ü      25 severely burned children were followed for 1 year to ascertain the duration
of the hypermetabolic-hypercatabolic state.  Stable isotope metabolic and body
composition studies were performed during hospitalization, at initial hospital
discharge and at 6, 9 and 12 months post-burn.  The resting energy expenditure
of these children peaked at 1-week post-injury with a metabolic rate of 180%
of normal and progressively declined with time.  At the time of exit from the

      study, i.e. 12 months, their resting energy expenditure was still 15% above basal

      metabolic rate.  Catabolism persisted for at least 9 months, which was 7 months

      after complete wound healing.  This is the first scientific documentation that

      the physiologic derangement incited by acute burn injury continues for many

      months after full healing of all wounds.

ü      Preliminary data suggests that with administration of GH from discharge to one year

      post-burn, bone loss is attenuated, with increases in bone mass preceded by

      increases in lean body mass.

ü      If continued study confirms what we have found to date it would suggest that

      recombinant human growth hormone combats post-burn hypermetabolism and,

      alone or in combination with exercise, can restore bone mineral and bone size.

ü      Oxandrolone, which can be given orally rather than via daily injections, appears
to significantly increase protein synthesis and is being studied as a potential

      replacement for GH for long-term anabolic agent administration.  

   Study  3:  Prospective randomized study of the effectiveness of pressure garment therapy for the prevention of hypertrophic scarring in burned children.

In group A,  i.e. children with lesser injuries, application of  'pressure'  is compared
to  'no pressure';  in group B,  i.e. children with larger injuries, 'low pressure' is
compared to 'high pressure'.  This study is progressing as planned and its findings
appear to be revolutionary as listed below:
 

ü      The comparison of  'pressure'  vs. 'no pressure'  revealed only a difference in
scar height between the 10 children receiving no pressure and the 18 children
receiving pressure; there were no differences in pigmentation, vascularity, or pliability
of scars as measured by the Vancouver Burn Scar Assessment Scale (VBSAS) nor
were there differences in range of motion.

ü      The comparison of the 'high' vs. 'low' pressure applications revealed no significant
differences in either qualities of burn scar or in range of motion at 12 months
post-injury. 

ü      Limitations in activities of daily living could be related to effects of pressure for neither
group.

ü      Likewise, a panel of plastic surgeons and rehabilitation therapists could not distinguish

      one group from another based on appearance of scar in color photographs.
 

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 GOAL 2: Develop and evaluate outreach programs to improve follow-up services for rural populations

  Study  4:  Community reintegration for the burned child.

This study has not progressed as planned.  Beginning during the second year of the
project, we became aware that the dramatic change in our patient population,
i.e. the abrupt increase in patients from outside the United States, demanded a change
of plan regarding community reintegration. The trend continued, and we now receive
a steady flow of severely burned children who are transported to our hospital from
all parts of Mexico.  As noted earlier, we now have outreach clinics in Mexico City,
Monterrey, and Guadalajara.  We had begun making individualized teaching videotapes
to be shown to professional and lay members of the child's community in these distant
locales to address the issue of reentry and planned to follow these children and their
communities as a separate group to be described, but not compared to those children
from the USA. 

During the last year, we have developed a network of psychologists and social workers
in Mexico City and Guadalajara through the outreach clinics and have sent a team
of "reentry trainers" from our hospital to make visits to selected communities of our
patients with the colleagues from that region.  Together, they have conducted reentry
programs following the same format we use in the USA.  As noted earlier, we have
made a total of 60 videos sent without a visit - and 50 reintegration visits -
and are back on track, developing a design for evaluating the effectiveness of
reintegration programs within Mexico and the US.

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   GOAL 3: To develop and evaluate measures of functional outcome for burn
                                                             rehabilitation

   GOAL 4: To identify and evaluate interventions, including vocational rehabilitation and special education interventions, to improve psychosocial adjustment, quality of life, community integration, as well as education- and employment-related outcomes.

  Study  5:  Longitudinal outcome study of the psychosocial recovery of burned children.

            Having begun the project with 250 subjects in the database, we have now entered  658.
            However, most of the information that is truly longitudinal is from the patients entered
            prior to the BMS.

ü      Analyses of those data have shown that the majority (70-80%) of pediatric burn survivors
do not have serious behavioral problems, but that a significant minority do have
diminished social competence.

ü      The troubled behaviors of very young burned children (2 & 3 year olds) are expressed
by internalizing behaviors, e.g.withdrawal, and of the older children by externalizing,
e.g. aggression.

ü      Burned children, even with massive injuries, do not appear to have functional
impairments as measured by the standard activities of daily living scales.
Only amputations of upper extremities seem to impede their activities, and, with
prosthetic and adaptive devices, they can become quite independent.

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   GOAL 5: To create a real-time cost capture system in order to facilitate comparisons of treatment interventions.  In combination with evaluations of effectiveness of interventions, to compare outcomes to cost in order to determine which treatment(s) are most cost effective.

            Because there are no charges to patients and families at SHC-G, we are in a position to
            determine actual costs of the burn care we provide.  We developed an algorithm
            for estimating cost per patient on the acute service based on actual costs to the
            hospital for one year and are currently using that algorithm to estimate costs for the
            year 2000.  We also are working collaboratively with the BMS in Seattle to
            compare our estimated costs with their charges to patients.

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    GOAL 6: To collaborate with other Burn Rehabilitation Model Systems in order to include a sufficient number of patients in any one study to give sufficient power to statistical analyses so that we can answer some questions heretofore unanswered.

            Although not in itself a research project, this is the most important part of the project,
            for without this collaboration burn care research will continue to be stymied by the small
            numbers of patients available for study in any single burn center.  This difficulty is      
            particularly true for pediatric patients where, for interpretation of most variables, data
            analyses must consider developmental stages and gender of the children, separating  
            samples again into even smaller numbers.                                                                 

ü       Galveston, as the only site with extensive pediatric experience, contributed heavily
 to the modifications of the database to make it relevant for burned children.

ü      We have entered data for 357 patients, which is over 40% of the pediatric population
 in the database.

ü       Collectively, the BMS sites are now approaching having sufficient numbers to answer
 questions about pediatric burn injury that have heretofore been unanswered because
 of limitations of sample size. 

Ø      Brief Summary of Key Accomplishments Across Components of MS Program: 

§         We continue to be most enthusiastic about the data from the first two studies,
i.e. resistance exercise and anabolic agents (e.g. growth hormone). 

§         We have collected enough data in those studies to be able to report in numerous
scientific abstracts, papers, and book chapters the indicators that these
2 innovations in treatment make an important difference in the strength,
endurance, bone density, and overall well being of severely burned children.

§         The institution of the intensive rehabilitation study has influenced our
care of burned children and their families in important ways that we had
not fully anticipated.  We began to think in a new way about the goals of
rehabilitation of severely burned children.  With the institution of the 3-month
intensive, on-site rehabilitation program, our treatment paradigm changed
from that of healing to one that additionally promotes wellness.

We now:

¨      include programming for the parents/guardians of the children as well as

      for the children; 

¨      have been enabled to make greater use of group settings for activities
such as exercise, education, and psychotherapy with all the benefits of
normalization and socialization afforded by group participation;

¨      are developing better methods of dealing with issues such as grief and
anger that so often impede progress in rehabilitation.

§         Two prestigious site visit teams whose expert members, upon hearing about
our intensive multidisciplinary program and observing the enthusiasm of our staff,
not only gave us exemplary evaluative marks, but observed that this new
paradigm should become the new standard of rehabilitation therapy for children
who survive massive burn injury.  This intensive and inclusive rehabilitation
program should be noted as the cornerstone achievement of this model

      systems project.

§         The pressure garment study also promises to have dramatic and revolutionary
impact upon burn care. If results continue as they have to date and strong
pressure seems to make no difference in the outcome of much of the resultant
scarring, the discomfort of burned children and the discord caused in families
of burned children around the issue of compliance will be greatly diminished.

§         The finding of diminished social skills among pediatric burn survivors has pointed
us in the direction of an important intervention that we are now testing in a
separate study of adolescent survivors who are “troubled”.

§         Collectively with the other BMS, we are reaching the point of having enough

      pediatric data to answer important questions heretofore unanswerable because
of limitations of site specific sample sizes.

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HIGHLIGHTS OF RECOMMENDATIONS FOR FUTURE DIRECTIONS
 

Ø   Within our local model system, our future plans entail

·        continued study of interactions between exercise, catabolism and anabolic agents,
looking for anabolic agents equally effective to recombinant human growth hormone that are also less noxious for long-term administration than daily injections.

·        We anticipate doubling our patient numbers in Study 1 in the next year in order
to attain statistical power.

·        Additionally, we plan to study various doses of exercise intensity, frequency and
duration to investigate the exercise dose that is most efficient in eliciting an increase
in muscle mass and strength.

·        We hope to develop a comparable intensive exercise program for children under
6 years of age.

·        Continue the evaluation of pressure as it relates to pruritis, comfort, and  cosmesis.

·        Analyze data relating psychosocial adjustment to participation in anabolic
and/or intensive rehab. studies.

·        Examine whether these data differ by country of origin, i.e. US vs. Hispanic
cultures outside US, or by size of burn.

·        Re-institute the study of types of reintegration programs following training a
team within Mexico to conduct community/school visits.

Ø      In collaboration with the other BMS, we plan to

·        Analyze the psychosocial data for this large sample to re-examine some basic
questions about factors that predict positive adaptation

·        Plan a cross-sectional study of developmental stage and adaptation to burn injury

·        Add dimensions of  ‘satisfaction with appearance’ and impairment resulting
from damaged skin and scarring because clinical experience suggests that these
are the areas of  “functional impairment” for burn survivors rather than their
abilities to perform tasks.

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