Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 1:19 AM
Study NCT ID:
NCT04677166
Status:
TERMINATED
Last Update Posted:
2025-06-13
First Post:
2020-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coupling Negative Pressure Wound Therapy With Instillation
Sponsor:
Loma Linda University
Organization:
Study Overview
Official Title:
Coupling Negative Pressure Wound Therapy With Instillation for Optimal Graft Take: Randomized Prospective Pilot Study
Status:
TERMINATED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
At the American Society of Plastic Surgeons 2024 Meeting, an abstract was presented demonstrating substantial superiority of the technology employed in the experimental arm of this study versus the control.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to compare standard negative pressure wound therapy with negative pressure wound therapy coupled with instillation for optimal skin graft take. Either the V.A.C ULTA NPWT or V.A.C. VeraFlo Therapy systems with normal saline will be applied intra-operatively to split-thickness skin grafts of upper and lower extremity wounds and kept in place for a duration of four days. Following completion of four days, the skin graft with be assessed for percentage of take/adherence and will be covered with simple gauze dressings as needed.
Detailed Description:
Past studies have investigated the use of NPWT for post-operative skin graft treatment and shown superior outcomes regarding graft take and need for repeat grafting when compared with standard gauze dressing. However, to date, no study has compared standard NPWT to NPWT coupled with instillation for post-operative treatment of extremity skin grafts. This study is designed as a randomized, controlled pilot study to compare treatment standard NPWT with NPWT coupled with instillation on skin graft take.
Patients will be selected based on inclusion criteria and randomized to either the treatment (NPWT coupled with instillation) or the control group (standard NPWT). Depending on the group to which they are randomized to, patients will have standard NPWT or NPWT coupled with instillation applied intra-operatively after application of split thickness skin graft for treatment of extremity wound.
Patients randomized to control group will receive V.A.C Ulta NPWT at 125mmHg continuous pressure for duration of four days.
Patients randomized to treatment group will receive V.A.C VeraFlo therapy. Protocol will consist of the following:
* Instillation solution: normal saline
* Dwell/soak time: 30 seconds
* Cycle Time: 4 hours
* Pressure: 125mmHg
The devices will be kept in place for four days, at which point, the wound vacs will be removed and the percentage of skin graft take will be evaluated with use of photometric analysis. The skin grafts will be subsequently dressed with gauze as appropriate. Patients will be followed up in clinic to assess outcome of skin graft take.
Patients will be selected based on inclusion criteria and randomized to either the treatment (NPWT coupled with instillation) or the control group (standard NPWT). Depending on the group to which they are randomized to, patients will have standard NPWT or NPWT coupled with instillation applied intra-operatively after application of split thickness skin graft for treatment of extremity wound.
Patients randomized to control group will receive V.A.C Ulta NPWT at 125mmHg continuous pressure for duration of four days.
Patients randomized to treatment group will receive V.A.C VeraFlo therapy. Protocol will consist of the following:
* Instillation solution: normal saline
* Dwell/soak time: 30 seconds
* Cycle Time: 4 hours
* Pressure: 125mmHg
The devices will be kept in place for four days, at which point, the wound vacs will be removed and the percentage of skin graft take will be evaluated with use of photometric analysis. The skin grafts will be subsequently dressed with gauze as appropriate. Patients will be followed up in clinic to assess outcome of skin graft take.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: