The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
NCT ID: NCT02565043
Last Updated: 2018-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2015-04-30
2016-11-30
Brief Summary
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Detailed Description
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The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to ensure minimum numbers in each group for analysis.
The primary objective of the study is to determine the time (days) to achieve the point where the reference wound is ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RENASYS TOUCH Negative Pressure Wound Therapy Device
Active Device: "RENASYS TOUCH NPWT" device administered to all patients using the intermittent/variable therapy mode, for up to 28 days of therapy.
RENASYS TOUCH Negative Pressure Wound Therapy System
RENASYS TOUCH NPWT System was administered to all participants.
RENASYS TOUCH Negative Pressure Wound Therapy System
Active Device: "RENASYS TOUCH NPWT" device administered to all patients using the continuous therapy mode for up to 28 days of therapy.
RENASYS TOUCH Negative Pressure Wound Therapy System
RENASYS TOUCH NPWT System was administered to all participants.
Interventions
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RENASYS TOUCH Negative Pressure Wound Therapy System
RENASYS TOUCH NPWT System was administered to all participants.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient consents to the on-going use of their de-identified photos by the Sponsor for purposes outside of this study
* Patients must be at least 18 years old
* Males and females. If female, they must not be pregnant. If female and of reproductive age, a pregnancy test will be provided
* Patient must have an acute, sub-acute or chronic wound that would benefit from the application of topical Negative Pressure Wound Therapy (NPWT)
* Patients must have an acute or sub-acute wound requiring wound bed preparation for an expected minimum of 4 days in advance of either planned surgical closure (including delayed primary closure, flaps or grafts) or planned secondary closure, OR a chronic wound requiring wound bed preparation in advance of planned surgical closure (not secondary intention)
* The patient, or the patient's legal representative, if the patient is incapable of giving legal consent, is able to understand the trial and is willing to consent to the trial
Exclusion Criteria
* Patients who have participated in this study previously and who \[healed or\] were withdrawn.
* Patients who are unable to understand the aims and objectives of the study.
* Presence of necrotic tissue, or \>25% slough in the reference wound bed. Once debridement has taken place, treatment with the investigational product may proceed
* Patients whose reference wound displays evidence of extensive tunnelling or sinus tracts
* Previously confirmed and untreated osteomyelitis
* Malignancy in the reference wound
* Non-enteric and unexplored Fistulas
* Presence of untreated infection in the reference wound bed (Infection must be treated with systemic antibiotics to permit inclusion in the trial and can be administered concurrently during the trial treatment regime)
* Active bleeding. Once haemostasis has been achieved, treatment with the investigational product may proceed
* Exposure of blood vessels or organs at the base of the reference wound
* Patients with a known history of poor compliance with medical treatment
* Patients who have participated in this trial previously and who healed or were withdrawn
* Patients treated on an out-patient basis who cannot continue to be treated as out-patients and/or attend the clinic for dressing changes as detailed in the treatment regimen of the study protocol
* Patients whose wounds are not suitable for treatment with intermittent therapy mode (e.g. highly exuding wounds, wounds with tunnels or undermining, wounds in difficult areas where maintaining a seal is problematic, patients who experience severe pain during intermittent therapy)
* Patients who are employees of Smith \& Nephew group companies.
18 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Forlee, MD
Role: PRINCIPAL_INVESTIGATOR
Dr Matley & Partners
Locations
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Tiervlei Trail Centre
Bellville, Cape Town, South Africa
Dr Matley & Partners
Claremont, Cape Town, South Africa
Countries
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References
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Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.
Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.
Krug E, Berg L, Lee C, Hudson D, Birke-Sorensen H, Depoorter M, Dunn R, Jeffery S, Duteille F, Bruhin A, Caravaggi C, Chariker M, Dowsett C, Ferreira F, Martinez JM, Grudzien G, Ichioka S, Ingemansson R, Malmsjo M, Rome P, Vig S, Runkel N, Martin R, Smith J; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]. Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus. Injury. 2011 Feb;42 Suppl 1:S1-12. doi: 10.1016/S0020-1383(11)00041-6.
Birke-Sorensen H, Malmsjo M, Rome P, Hudson D, Krug E, Berg L, Bruhin A, Caravaggi C, Chariker M, Depoorter M, Dowsett C, Dunn R, Duteille F, Ferreira F, Francos Martinez JM, Grudzien G, Ichioka S, Ingemansson R, Jeffery S, Lee C, Vig S, Runkel N; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]; Martin R, Smith J. Evidence-based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer)--steps towards an international consensus. J Plast Reconstr Aesthet Surg. 2011 Sep;64 Suppl:S1-16. doi: 10.1016/j.bjps.2011.06.001. Epub 2011 Aug 24.
Vig S, Dowsett C, Berg L, Caravaggi C, Rome P, Birke-Sorensen H, Bruhin A, Chariker M, Depoorter M, Dunn R, Duteille F, Ferreira F, Martinez JM, Grudzien G, Hudson D, Ichioka S, Ingemansson R, Jeffery S, Krug E, Lee C, Malmsjo M, Runkel N; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]; Martin R, Smith J. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus. J Tissue Viability. 2011 Dec;20 Suppl 1:S1-18. doi: 10.1016/j.jtv.2011.07.002. Epub 2011 Nov 25.
Hudson DA, Adams KG, Van Huyssteen A, Martin R, Huddleston EM. Simplified negative pressure wound therapy: clinical evaluation of an ultraportable, no-canister system. Int Wound J. 2015 Apr;12(2):195-201. doi: 10.1111/iwj.12080. Epub 2013 May 7.
Clare MP, Fitzgibbons TC, McMullen ST, Stice RC, Hayes DF, Henkel L. Experience with the vacuum assisted closure negative pressure technique in the treatment of non-healing diabetic and dysvascular wounds. Foot Ankle Int. 2002 Oct;23(10):896-901. doi: 10.1177/107110070202301002.
Mendonca DA, Cosker T, Makwana NK. Vacuum-assisted closure to aid wound healing in foot and ankle surgery. Foot Ankle Int. 2005 Sep;26(9):761-6. doi: 10.1177/107110070502600915.
McCallon SK, Knight CA, Valiulus JP, Cunningham MW, McCulloch JM, Farinas LP. Vacuum-assisted closure versus saline-moistened gauze in the healing of postoperative diabetic foot wounds. Ostomy Wound Manage. 2000 Aug;46(8):28-32, 34.
Other Identifiers
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CT13/01
Identifier Type: -
Identifier Source: org_study_id
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