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Coupling Negative Pressure Wound Therapy With Instillation

Primary Purpose

Wound, Ulcer, Burns

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative pressure wound therapy coupled with instillation
Standard Negative Pressure Wound Therapy
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have been offered split-thickness skin graft for treatment of an extremity wound.

Exclusion Criteria:

  • Abnormal healing (diagnosed with connective tissue disorder)
  • Uncontrolled diabetes mellitus (HgbA1c >9)

Sites / Locations

  • Loma Linda UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NPWT with Instillation

Standard NPWT

Arm Description

NPWT coupled with instillation will be employed via use of V.A.C. VeraFlo device. The protocol to be used is as follows: Instillation Solution: normal saline Dwell/Soak Time: 30 seconds Cycle Time: 4 hours Pressure: 125mmHg

Standard NPWT with use of V.A.C. Ulta device employed at 125mmHg continuous suction.

Outcomes

Primary Outcome Measures

Percentage of Skin Graft Take at Four Days Post-Operative
percentage of skin graft take at time of wound vac take down (4 days post-op)

Secondary Outcome Measures

Percentage of Skin Graft Take at Thirty Days Post-Operative
percentage of skin graft take at follow up clinic appointment

Full Information

First Posted
December 17, 2020
Last Updated
April 24, 2023
Sponsor
Loma Linda University
Collaborators
Acelity, 3M
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1. Study Identification

Unique Protocol Identification Number
NCT04677166
Brief Title
Coupling Negative Pressure Wound Therapy With Instillation
Official Title
Coupling Negative Pressure Wound Therapy With Instillation for Optimal Graft Take: Randomized Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
Collaborators
Acelity, 3M

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Ulcer, Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to either the treatment group (negative pressure wound therapy coupled with instillation) or the control group (standard negative pressure wound therapy). Both groups will receive four days of intervention and outcomes will be measured at day four of negative pressure wound therapy and at thirty days post-operatively.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NPWT with Instillation
Arm Type
Experimental
Arm Description
NPWT coupled with instillation will be employed via use of V.A.C. VeraFlo device. The protocol to be used is as follows: Instillation Solution: normal saline Dwell/Soak Time: 30 seconds Cycle Time: 4 hours Pressure: 125mmHg
Arm Title
Standard NPWT
Arm Type
Active Comparator
Arm Description
Standard NPWT with use of V.A.C. Ulta device employed at 125mmHg continuous suction.
Intervention Type
Device
Intervention Name(s)
Negative pressure wound therapy coupled with instillation
Intervention Description
Use of V.A.C. VeraFlo to treat skin grafts with NPWT coupled with instillation.
Intervention Type
Device
Intervention Name(s)
Standard Negative Pressure Wound Therapy
Intervention Description
standard negative pressure wound therapy via V.A.C. Ulta device at 125mmHg suction.
Primary Outcome Measure Information:
Title
Percentage of Skin Graft Take at Four Days Post-Operative
Description
percentage of skin graft take at time of wound vac take down (4 days post-op)
Time Frame
4 days from intervention
Secondary Outcome Measure Information:
Title
Percentage of Skin Graft Take at Thirty Days Post-Operative
Description
percentage of skin graft take at follow up clinic appointment
Time Frame
30 days from intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have been offered split-thickness skin graft for treatment of an extremity wound. Exclusion Criteria: Abnormal healing (diagnosed with connective tissue disorder) Uncontrolled diabetes mellitus (HgbA1c >9)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie W Holzmer, MD
Phone
(909) 558-8085
Email
sholzmer@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Subhas Gupta, MD, PhD
Phone
(909) 558-8085
Email
sgupta@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhas W Gupta, MD, PhD
Organizational Affiliation
Loma Linda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Holzmer
Phone
909-558-8085
Email
sholzmer@llu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29292216
Citation
Yin Y, Zhang R, Li S, Guo J, Hou Z, Zhang Y. Negative-pressure therapy versus conventional therapy on split-thickness skin graft: A systematic review and meta-analysis. Int J Surg. 2018 Feb;50:43-48. doi: 10.1016/j.ijsu.2017.12.020. Epub 2017 Dec 29.
Results Reference
background
PubMed Identifier
25162948
Citation
Nguyen TQ, Franczyk M, Lee JC, Greives MR, O'Connor A, Gottlieb LJ. Prospective randomized controlled trial comparing two methods of securing skin grafts using negative pressure wound therapy: vacuum-assisted closure and gauze suction. J Burn Care Res. 2015 Mar-Apr;36(2):324-8. doi: 10.1097/BCR.0000000000000089.
Results Reference
background

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Coupling Negative Pressure Wound Therapy With Instillation

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