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

NCT04618406 | Active Not Recruiting FDA Device

• 1 other identifier: SHS-KI-09-2020
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Negative-Pressure Wound Therapy; Amputation; Wound Heal

Keywords

Vascular disease; Diabetes; Preventive Care; Medical technology; Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  Measured at 5 days and 2, 3 and 6 weeks

Secondary Outcomes (2)

• Number of participants requiring re-surgery

  Within the first 6 weeks after surgery

• Number of participants requiring re-amputation

  Within the first 6 weeks after surgery

Study Arms (2)

PICO VAC

EXPERIMENTAL

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.

Device: PICO VAC

Standard care

ACTIVE COMPARATOR

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

Other: Standard care

Interventions

PICO VAC DEVICE

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.

Also known as: PICO VAC (Smith and Nephew)

PICO VAC

Standard care OTHER

Sterile surgical silicone foam dressing and soft dressing applied immediately postoperative and removed after 12 days

Also known as: Sterile surgical silicone foam dressing and soft dressing

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Location

Related Publications (12)

• 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.

  PMID: 21723151 BACKGROUND

• 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.

  PMID: 21840153 BACKGROUND

• 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.

  PMID: 30472722 BACKGROUND

• 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.

  PMID: 17425550 BACKGROUND

• Sepulveda G, Espindola M, Maureira M, Sepulveda E, Ignacio Fernandez J, Oliva C, Sanhueza A, Vial M, Manterola C. [Negative-pressure wound therapy versus standard wound dressing in the treatment of diabetic foot amputation. A randomised controlled trial]. Cir Esp. 2009 Sep;86(3):171-7. doi: 10.1016/j.ciresp.2009.03.020. Epub 2009 Jul 18. Spanish.

  PMID: 19616774 BACKGROUND

• Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.

  PMID: 16291063 BACKGROUND

• Liu X, Zhang H, Cen S, Huang F. Negative pressure wound therapy versus conventional wound dressings in treatment of open fractures: A systematic review and meta-analysis. Int J Surg. 2018 May;53:72-79. doi: 10.1016/j.ijsu.2018.02.064. Epub 2018 Mar 16.

  PMID: 29555530 BACKGROUND

• Norman G, Goh EL, Dumville JC, Shi C, Liu Z, Chiverton L, Stankiewicz M, Reid A. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2020 May 1;5(5):CD009261. doi: 10.1002/14651858.CD009261.pub5.

  PMID: 32356396 BACKGROUND

• 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.

  PMID: 24352756 BACKGROUND

• 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.

  PMID: 27496913 BACKGROUND

• Nherera LM, Trueman P, Karlakki SL. Cost-effectiveness analysis of single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical site complications (SSC) in routine primary hip and knee replacements. Wound Repair Regen. 2017 May;25(3):474-482. doi: 10.1111/wrr.12530. Epub 2017 May 3.

  PMID: 28370637 BACKGROUND

• Fisher DF Jr, Clagett GP, Fry RE, Humble TH, Fry WJ. One-stage versus two-stage amputation for wet gangrene of the lower extremity: a randomized study. J Vasc Surg. 1988 Oct;8(4):428-33.

  PMID: 3172378 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases; Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lars Grau Lykkeberg, MD

  Hospital Sonderjylland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 5, 2020
• Study Start: November 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)