Ignite Creation Date:
2024-05-06 @ 12:49 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01668030
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2012-08-08
Brief Title:
Comparison of Wound Bed Establishment in Facial Burns
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Comparison of Wound Bed Establishment in Facial Burns Using Two Standard Ointments
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Forty percent of patients admitted to the contributing regional burn unit over a five month period received facial burns n14 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 eg 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 individuals demographic variables treatment type pain anxiety itching levels and scarring Significance for all analysis will be at the 005 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
Detailed 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 p007 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 unitsgram 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 mediatingmoderating 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 eg 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 ie 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 investigators 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 eg nurses andor 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 eg costs associated with travel and missing work so the patients 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 091 and 094 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 P001 for all and correctly identified fluctuations within patients over time P001 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 eg 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 1no itch and 10the 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 professionals and patient-based need for scar assessment whereas the Vancouver Scar Scale VSS only assesses scar severity from the professionals 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 patients 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 1no complaints normal skin 10worst imaginablevery 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 Cronbachs alpha 076 patient and 069 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
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 p007 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 unitsgram 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 mediatingmoderating 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 eg 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 ie 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 investigators 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 eg nurses andor 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 eg costs associated with travel and missing work so the patients 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 091 and 094 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 P001 for all and correctly identified fluctuations within patients over time P001 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 eg 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 1no itch and 10the 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 professionals and patient-based need for scar assessment whereas the Vancouver Scar Scale VSS only assesses scar severity from the professionals 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 patients 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 1no complaints normal skin 10worst imaginablevery 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 Cronbachs alpha 076 patient and 069 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None