Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011531
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2001-02-22
Brief Title:
Investigation of Subatmospheric Pressure Dressing on Pressure Ulcer Healing
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Investigation of Subatmospheric Pressure Dressing on Pressure Ulcer Healing
Status:
COMPLETED
Status Verified Date:
2001-01
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:
Many spinal cord injury SCI and otherwise debilitated patients develop pressure ulcers over the course of their injury or disease Despite enhanced wound care management many pressure ulcers do not heal completely and require surgical myocutaneous rotational flap coverage Even then they often recur
The objectives of this study are 1 to conduct a controlled comparative study of the effectiveness of subatmospheric pressure dressing SPD in healing pressure ulcers versus conventional saline wet-to-moist dressing techniques 2 to establish indications and contra-indications for use of SPD In treating pressure ulcers and 3 to develop a noninvasive clinically usable optical digitizer and associated software for measurement of wound geometry for standardized quantitative assessment and longitudinal monitoring of wound healing
The objectives of this study are 1 to conduct a controlled comparative study of the effectiveness of subatmospheric pressure dressing SPD in healing pressure ulcers versus conventional saline wet-to-moist dressing techniques 2 to establish indications and contra-indications for use of SPD In treating pressure ulcers and 3 to develop a noninvasive clinically usable optical digitizer and associated software for measurement of wound geometry for standardized quantitative assessment and longitudinal monitoring of wound healing
Detailed Description:
Many spinal cord injury SCI and otherwise debilitated patients develop pressure ulcers over the course of their injury or disease Despite enhanced wound care management many pressure ulcers do not heal completely and require surgical myocutaneous rotational flap coverage Even then they often recur
HYPOTHESIS Subatmospheric pressure dressing SPD treatment applied to pressure ulcers will either completely close them or heal to a point allowing for skin graft coverage more often than 09 normal saline wet-to-moist dressing WTMD treatment
OBJECTIVES The objectives of this study are 1 to conduct a controlled comparative study of the effectiveness of subatmospheric pressure dressing SPD in healing pressure ulcers versus conventional saline wet-to-moist dressing techniques 2 to establish indications and contra-indications for use of SPD In treating pressure ulcers and 3 to develop a noninvasive clinically usable optical digitizer and associated software for measurement of wound geometry for standardized quantitative assessment and longitudinal monitoring of wound healing
RESEARCH METHODS 120 patients with stage III or IV pressure ulcers meeting the project selection criteria will be recruited for the project Patients will be randomly assigned in a 31 SPD to WTMD ratio to either the control group receiving 09 normal saline wet-to-moist wound dressing and treatment or to the subatmospheric pressure dressing group All subjects selected will be further stratified according to degree of wound severity nutritional status and evidence of wound infection The WTMD group will receive 09 NS moistened gauze applied to the wound which will be changed every 8 hours The SPD group will receive SPD dressing with the VACTM system set at a constant subatmospheric pressure of negative 125 mmHg The SPD device and dressing will be left in place and changed every Monday Wednesday and Friday The subjects pressure ulcers will be measured on day 0 and then on a weekly basis Ulcer surface shape area and coloration will be recorded with a digital camera and also by tracing the ulcer perimeter on a flexible translucent plastic film with grid overlaid on the wound In addition an optical laser scanner will used to record ulcer shape area and coloration and bodylimb segmental volume in the region of the wound Volume will also be measured using alginate wound impressions to form RTV silicone molds for fluid displacement measurement The molds of the wounds will also be optically digitized and wound perimeter topical surface area total 3-D surface area and volume calculated using computer image processing planimetry and volumetry software developed in the project Local bodylimb segment volume will also be calculated to monitor edematous fluctuations Based on these measurements the wound responses will be scored as described in Table 2 after one month or at the time of the patients withdrawal from the study The association between response level and treatment type will be analyzed using Chi-square test of association Mantel-Haenszel Chi-square and logistic regression will be used to control for prognostic variables
HYPOTHESIS Subatmospheric pressure dressing SPD treatment applied to pressure ulcers will either completely close them or heal to a point allowing for skin graft coverage more often than 09 normal saline wet-to-moist dressing WTMD treatment
OBJECTIVES The objectives of this study are 1 to conduct a controlled comparative study of the effectiveness of subatmospheric pressure dressing SPD in healing pressure ulcers versus conventional saline wet-to-moist dressing techniques 2 to establish indications and contra-indications for use of SPD In treating pressure ulcers and 3 to develop a noninvasive clinically usable optical digitizer and associated software for measurement of wound geometry for standardized quantitative assessment and longitudinal monitoring of wound healing
RESEARCH METHODS 120 patients with stage III or IV pressure ulcers meeting the project selection criteria will be recruited for the project Patients will be randomly assigned in a 31 SPD to WTMD ratio to either the control group receiving 09 normal saline wet-to-moist wound dressing and treatment or to the subatmospheric pressure dressing group All subjects selected will be further stratified according to degree of wound severity nutritional status and evidence of wound infection The WTMD group will receive 09 NS moistened gauze applied to the wound which will be changed every 8 hours The SPD group will receive SPD dressing with the VACTM system set at a constant subatmospheric pressure of negative 125 mmHg The SPD device and dressing will be left in place and changed every Monday Wednesday and Friday The subjects pressure ulcers will be measured on day 0 and then on a weekly basis Ulcer surface shape area and coloration will be recorded with a digital camera and also by tracing the ulcer perimeter on a flexible translucent plastic film with grid overlaid on the wound In addition an optical laser scanner will used to record ulcer shape area and coloration and bodylimb segmental volume in the region of the wound Volume will also be measured using alginate wound impressions to form RTV silicone molds for fluid displacement measurement The molds of the wounds will also be optically digitized and wound perimeter topical surface area total 3-D surface area and volume calculated using computer image processing planimetry and volumetry software developed in the project Local bodylimb segment volume will also be calculated to monitor edematous fluctuations Based on these measurements the wound responses will be scored as described in Table 2 after one month or at the time of the patients withdrawal from the study The association between response level and treatment type will be analyzed using Chi-square test of association Mantel-Haenszel Chi-square and logistic regression will be used to control for prognostic variables
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