Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493539
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-05-05
Brief Title:
CiNPWT Lower Extremity Amputations Closed Incision Neagtive Pressure Wound Therapy
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Novel Application of Closed Incision Negative Pressure Wound Therapy for the Post-Surgical Management of Lower Extremity Amputations A Randomized Clinical Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
CiNPWT
Brief Summary:
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound TherapyCiNPWT as delivered by the VAC Ulta Therapy System 3M USA in individuals who have undergone a Lower Extremity AmputationLEA compared with standard of care compression wrapping and wound care post-LEA
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA trans-metatarsal or higher randomized between intervention novel application of CiNPWT and a control group standard care
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA trans-metatarsal or higher randomized between intervention novel application of CiNPWT and a control group standard care
Detailed Description:
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy CiNPWT as delivered by the VAC Ulta Therapy System 3M USA in individuals who have undergone a Lower Extremity Amputation LEA compared with standard of care compression wrapping and wound care post-LEA
Specific objectives
1 Collect demographics and relevant data eg risk factors and comorbidities to compare intervention and control groups
2 Measure post-surgical outcomes and compare both groups
STUDY DESIGN
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA trans-metatarsal or higher randomized between intervention novel application of CiNPWT and a control group standard care
DEVICE INFORMATION
The VAC Ulta Therapy System 3M USA is a non-invasive wound closure system that uses controlled localized negative pressure to promote healing in chronic and acute wounds The subatmospheric ie negative pressure system uses latex-free and sterile polyurethane or polyvinyl alcohol foam dressings that are individualized at the bedside to the appropriate size for every patient and then covered with an adhesive drape to create an airtight seal A SensaTRAC Pad directly contacts the foam dressing and accurately senses monitors and maintains the target pressure at the wound site to provide controlled negative pressure Tubing attached to the SensaTRAC Pad connects to a fluid collection canister contained in a programmable portable computer-controlled vacuum pump creating negative pressure at the wound surface interface
Amputation and revisionre-amputation is a resection of a segment of a limb through a bone or through a joint
Major amputation Any resection proximal to the ankle
Major amputation levels
TT transtibial amputation amputation through the tibia and fibula frequently referred to as below knee amputation
KD knee disarticulation amputation through the knee frequently referred to as through knee amputation
TF transfemoral amputation amputation through the femur frequently referred to as above knee amputation
Minor amputation Any resection distal to the ankle
Minor amputation levels
TMA transmetartarsal amputation
The level will be determined using the electronic medical record of the patients and by the health care providers observations
Wound dehiscence partial or total is a surgery complication where the incision reopens Clinically reported by the health care providers This will be also evaluated with digital photographs
Infection at the surgical site andor cellulitis of the residual limb are pathological states caused by invasion and multiplication of microorganisms in host tissues accompanied by tissue destruction andor a host inflammatory response This is usually based on soft tissue infection clinical criteria from Infectious Disease Society of America IDSA and will be reported by the health care provider
Closed wound defined as complete epithelialization at the surgical site will be based on the health providers clinical decision combined with medical record documentation Determination is based on data from wound assessments and photographs performed by the treating clinician and documented in the Tissue Analytics wound imaging software Photographs will be taken during patient visits no more than 3xwk and if present wound size and tissue color percentages will be calculated by Tissue Analytics software Any wound depth present will be measured manually by the treating therapist and entered into the Tissue Analytics system Additional wound assessment characteristics that will be documented include periwound color and condition drainage type or amount and tissue type assessment Agreement between clinicians documentation of closure and photographic measurements will be used to ascertain time to closure
The tolerabilityacceptability of CiNPWT will be measured
Pain which is a physical suffering or discomfort caused by CiNPWT is usually reported by the patient using the visual analogue scale at each visit
Anxiety about the treatment using Hamilton Anxiety Rating Scale HAM-A
Quality of life using the Short Form-36 Questionaire
Baseline characteristics risk factors and comorbidities will be extracted from the electronic medical record and validated with physical examination Investigations can be done as necessary to complete missing data such as presenceabsence of neuropathy vascular status etc using best practice at the initial evaluation As an example blood samples will be obtained at the first evaluation to assess Hemoglobin A1c If a patient is deemed at nutrition risk based on a nutrition screen done by nursing Malnutrition Screening Tool a dietitian will be consulted and dietary supplementation will be initiated as needed
All unscheduled or emergency visits will be listed
At each encounter the time to complete the treatment including dressings and compression intervention and control will be recorded by the clinician in the Electronic Medical Record
Specific objectives
1 Collect demographics and relevant data eg risk factors and comorbidities to compare intervention and control groups
2 Measure post-surgical outcomes and compare both groups
STUDY DESIGN
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA trans-metatarsal or higher randomized between intervention novel application of CiNPWT and a control group standard care
DEVICE INFORMATION
The VAC Ulta Therapy System 3M USA is a non-invasive wound closure system that uses controlled localized negative pressure to promote healing in chronic and acute wounds The subatmospheric ie negative pressure system uses latex-free and sterile polyurethane or polyvinyl alcohol foam dressings that are individualized at the bedside to the appropriate size for every patient and then covered with an adhesive drape to create an airtight seal A SensaTRAC Pad directly contacts the foam dressing and accurately senses monitors and maintains the target pressure at the wound site to provide controlled negative pressure Tubing attached to the SensaTRAC Pad connects to a fluid collection canister contained in a programmable portable computer-controlled vacuum pump creating negative pressure at the wound surface interface
Amputation and revisionre-amputation is a resection of a segment of a limb through a bone or through a joint
Major amputation Any resection proximal to the ankle
Major amputation levels
TT transtibial amputation amputation through the tibia and fibula frequently referred to as below knee amputation
KD knee disarticulation amputation through the knee frequently referred to as through knee amputation
TF transfemoral amputation amputation through the femur frequently referred to as above knee amputation
Minor amputation Any resection distal to the ankle
Minor amputation levels
TMA transmetartarsal amputation
The level will be determined using the electronic medical record of the patients and by the health care providers observations
Wound dehiscence partial or total is a surgery complication where the incision reopens Clinically reported by the health care providers This will be also evaluated with digital photographs
Infection at the surgical site andor cellulitis of the residual limb are pathological states caused by invasion and multiplication of microorganisms in host tissues accompanied by tissue destruction andor a host inflammatory response This is usually based on soft tissue infection clinical criteria from Infectious Disease Society of America IDSA and will be reported by the health care provider
Closed wound defined as complete epithelialization at the surgical site will be based on the health providers clinical decision combined with medical record documentation Determination is based on data from wound assessments and photographs performed by the treating clinician and documented in the Tissue Analytics wound imaging software Photographs will be taken during patient visits no more than 3xwk and if present wound size and tissue color percentages will be calculated by Tissue Analytics software Any wound depth present will be measured manually by the treating therapist and entered into the Tissue Analytics system Additional wound assessment characteristics that will be documented include periwound color and condition drainage type or amount and tissue type assessment Agreement between clinicians documentation of closure and photographic measurements will be used to ascertain time to closure
The tolerabilityacceptability of CiNPWT will be measured
Pain which is a physical suffering or discomfort caused by CiNPWT is usually reported by the patient using the visual analogue scale at each visit
Anxiety about the treatment using Hamilton Anxiety Rating Scale HAM-A
Quality of life using the Short Form-36 Questionaire
Baseline characteristics risk factors and comorbidities will be extracted from the electronic medical record and validated with physical examination Investigations can be done as necessary to complete missing data such as presenceabsence of neuropathy vascular status etc using best practice at the initial evaluation As an example blood samples will be obtained at the first evaluation to assess Hemoglobin A1c If a patient is deemed at nutrition risk based on a nutrition screen done by nursing Malnutrition Screening Tool a dietitian will be consulted and dietary supplementation will be initiated as needed
All unscheduled or emergency visits will be listed
At each encounter the time to complete the treatment including dressings and compression intervention and control will be recorded by the clinician in the Electronic Medical Record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None