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The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb

Primary Purpose

Negative-Pressure Wound Therapy, Amputation, Wound Heal

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PICO VAC
Standard care
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Negative-Pressure Wound Therapy focused on measuring Vascular disease, Diabetes, Preventive Care, Medical technology, Surgery

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing transfemoral, knee disarticulations and transtibial amputations by non-traumatic indication
  • Uni or bilateral amputations or re-amputations

Exclusion Criteria:

  • Patients undergoing traumatic amputations
  • Unwilling or unable to provide informed consent
  • Inability to comply with planned study procedures
  • Amputations due to malignancy

Sites / Locations

  • Sygehus SoenderjyllandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PICO VAC

Standard care

Arm Description

PICO14 device from Smith and Nephew. It is a Single-Use Negative Pressure Wound Therapy Device that provides an effective negative pressure of -80 mmHg for 14 days. It is an easily applied all-in-one system that ensures uniform application each time it is applied. The dressing consists of 4 distinct layers that reduce the risk of skin trauma, applies equal negative pressure to the skin and manages fluid transport away from the wound through a combination of absorption and evaporation through an airlock layer. The device is approved for the treatment of open wounds, closed surgical incisions and skin grafts. Both PICO-VAC and soft dressing are applied immediately postoperatively and removed after 12 days.

Standard care (sterile surgical silicone foam dressing and soft dressing)

Outcomes

Primary Outcome Measures

Change in the number of wound complications
Dehiscence (skin or fascia), seroma, lymph leak, infection (CDC surgical site infection criteria), Hematoma, Ischemia, Necrosis requiring any further local surgical treatment

Secondary Outcome Measures

Number of participants requiring re-surgery
Revision surgery
Number of participants requiring re-amputation
Re-amputation

Full Information

First Posted
October 19, 2020
Last Updated
September 28, 2023
Sponsor
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04618406
Brief Title
The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb
Official Title
The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The socioeconomic costs of problematic and delayed wound healing following lower limb amputations are enormous to the society. Lower limb amputations is one of the longest known surgical treatments, but also one of the least investigated in the field of medical science. Negative Pressure Wound Therapy (NPWT) has emerged as a great instrument to aid healing. Studies have shown that it has a positive and measurable effect on wound healing following eg. total Knee and hip replacements. The aim of this study is to evaluate the effect of a closed NPWT on incidence of postoperative wound complications, in patients undergoing lower extremity amputation.
Detailed Description
Historically lower limb amputations have been performed to treat infection or trauma, usually in the setting of war. Today however major amputations of the lower extremities (transfemoral- (TFA), knee disarticulations (KD) and transtibial amputations (TTA)) are, in developed countries, usually performed in elderly patients with untreatable vascular disease, diabetes or a combination of both. This fragile group of patients are characterized by a high degree of comorbidity, mortality and both surgical and postoperative complications; included herein problems with wound healing. The tissue is typically poorly vascularized and prone to wound break-down, infections, necrosis etc. 10-40% of patients undergoing TFA, KD or TTA have delayed wound healing and/or insufficient wound healing, resulting in problems with the aftercare, mobilization with a prosthesis and re-amputations. Recent retrospective studies show that Negative Pressure Wound Therapy (NPWT) may have beneficial effects on incisional healing following lower limb amputations. However to our knowledge it has never been reproduced in a prospective randomized controlled setting.The aim of this study is to investigate the effect of NPWT with a PICO®️ device (Smith & Nephew) on the healing of the surgical wound following TFA, KD and TTA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative-Pressure Wound Therapy, Amputation, Wound Heal
Keywords
Vascular disease, Diabetes, Preventive Care, Medical technology, Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PICO VAC
Arm Type
Experimental
Arm Description
PICO14 device from Smith and Nephew. It is a Single-Use Negative Pressure Wound Therapy Device that provides an effective negative pressure of -80 mmHg for 14 days. It is an easily applied all-in-one system that ensures uniform application each time it is applied. The dressing consists of 4 distinct layers that reduce the risk of skin trauma, applies equal negative pressure to the skin and manages fluid transport away from the wound through a combination of absorption and evaporation through an airlock layer. The device is approved for the treatment of open wounds, closed surgical incisions and skin grafts. Both PICO-VAC and soft dressing are applied immediately postoperatively and removed after 12 days.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard care (sterile surgical silicone foam dressing and soft dressing)
Intervention Type
Device
Intervention Name(s)
PICO VAC
Other Intervention Name(s)
PICO VAC (Smith and Nephew)
Intervention Description
PICO14 device from Smith and Nephew - Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager-sized) suction device/canister and provides a negative pressure of -80 mmHg for 14 days.
Intervention Type
Other
Intervention Name(s)
Standard care
Other Intervention Name(s)
Sterile surgical silicone foam dressing and soft dressing
Intervention Description
Sterile surgical silicone foam dressing and soft dressing applied immediately postoperative and removed after 12 days
Primary Outcome Measure Information:
Title
Change in the number of wound complications
Description
Dehiscence (skin or fascia), seroma, lymph leak, infection (CDC surgical site infection criteria), Hematoma, Ischemia, Necrosis requiring any further local surgical treatment
Time Frame
Measured at 5 days and 2, 3 and 6 weeks
Secondary Outcome Measure Information:
Title
Number of participants requiring re-surgery
Description
Revision surgery
Time Frame
Within the first 6 weeks after surgery
Title
Number of participants requiring re-amputation
Description
Re-amputation
Time Frame
Within the first 6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing transfemoral, knee disarticulations and transtibial amputations by non-traumatic indication Uni or bilateral amputations or re-amputations Exclusion Criteria: Patients undergoing traumatic amputations Unwilling or unable to provide informed consent Inability to comply with planned study procedures Amputations due to malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Grau Lykkeberg, MD
Phone
+45 7997 6173
Email
lars.grau.lykkeberg@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Ougaard Schønnemann, MD
Phone
+ 45 79976170
Email
Jesper.Ougaard.Schoennemann1@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Grau Lykkeberg, MD
Organizational Affiliation
Hospital Sonderjylland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sygehus Soenderjylland
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21723151
Citation
Belmont PJ Jr, Davey S, Orr JD, Ochoa LM, Bader JO, Schoenfeld AJ. Risk factors for 30-day postoperative complications and mortality after below-knee amputation: a study of 2,911 patients from the national surgical quality improvement program. J Am Coll Surg. 2011 Sep;213(3):370-8. doi: 10.1016/j.jamcollsurg.2011.05.019. Epub 2011 Jul 1.
Results Reference
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21840153
Citation
Hasanadka R, McLafferty RB, Moore CJ, Hood DB, Ramsey DE, Hodgson KJ. Predictors of wound complications following major amputation for critical limb ischemia. J Vasc Surg. 2011 Nov;54(5):1374-82. doi: 10.1016/j.jvs.2011.04.048. Epub 2011 Aug 15.
Results Reference
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PubMed Identifier
30472722
Citation
Kotha V, Walter E, Stimac G, Kim P. Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Review. Surg Technol Int. 2019 May 15;34:49-55.
Results Reference
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PubMed Identifier
17425550
Citation
Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007 Mar;4(1):79-86. doi: 10.1111/j.1742-481X.2006.00270.x.
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PubMed Identifier
19616774
Citation
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Results Reference
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PubMed Identifier
16291063
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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PubMed Identifier
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Citation
Karlakki S, Brem M, Giannini S, Khanduja V, Stannard J, Martin R. Negative pressure wound therapy for managementof the surgical incision in orthopaedic surgery: A review of evidence and mechanisms for an emerging indication. Bone Joint Res. 2013 Dec 18;2(12):276-84. doi: 10.1302/2046-3758.212.2000190. Print 2013.
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Citation
Karlakki SL, Hamad AK, Whittall C, Graham NM, Banerjee RD, Kuiper JH. Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res. 2016 Aug;5(8):328-37. doi: 10.1302/2046-3758.58.BJR-2016-0022.R1.
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The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower Limb

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