Clinical trial NCT04618406: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Negative-Pressure Wound Therapy
Amputation
Wound Heal
Keywords: Vascular disease
Diabetes
Preventive Care
Medical technology
Surgery
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in the number of wound complications
timeFrame: Measured at 5 days and 2, 3 and 6 weeks
Secondary outcomes:
measure: Number of participants requiring re-surgery
timeFrame: Within the first 6 weeks after surgery
measure: Number of participants requiring re-amputation
timeFrame: Within the first 6 weeks after surgery
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Soenderjylland
Study officials:
affiliation: Hospital Sonderjylland
name: Lars Grau Lykkeberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
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.
citation: 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.
citation: 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.