The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds

NCT02565043 | Completed

• 1 other identifier: CT13/01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The study is looking at the clinical efficacy, functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) system in the management of a variety of wound types, in a real-life clinical setting. The study will comprise a prospective, open-labeled, multi-center study in a number of care-settings (both hospital and community) in South Africa. The patient's reference wound will be randomized to treatment with either intermittent or continuous NPWT mode to assess whether the delivery of NPWT via each of these therapy settings will have an effect on the rate and quality of wound healing.

Conditions

Wound and Injuries; Surgical Wound Dehiscence

Keywords

Negative Pressure Wound Therapy

Outcome Measures

Primary Outcomes (1)

• The time 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

  28 days

Secondary Outcomes (9)

• To determine the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention

  28 days

• To assess the percentage of wounds that are ready to be closed either by surgical intervention (STSG, simple flap or suturing) or by secondary intention, in wounds that are randomized to intermittent or continuous therapy mode

  28 days

• The percentage change in wound area

  28 days

• The number of patients with a confirmed clinical infection or presenting with clinical signs of infection

  28 days

• The number of patients with the condition of their surrounding skin recorded as either Healthy, Fragile, Inflamed, Macerated, Dry and Flaky, or Other

  28 days

Study Arms (2)

RENASYS TOUCH Negative Pressure Wound Therapy Device

EXPERIMENTAL

Active Device: "RENASYS TOUCH NPWT" device administered to all patients using the intermittent/variable therapy mode, for up to 28 days of therapy.

Device: RENASYS TOUCH Negative Pressure Wound Therapy System

RENASYS TOUCH Negative Pressure Wound Therapy System

ACTIVE COMPARATOR

Active Device: "RENASYS TOUCH NPWT" device administered to all patients using the continuous therapy mode for up to 28 days of therapy.

Device: RENASYS TOUCH Negative Pressure Wound Therapy System

Interventions

RENASYS TOUCH Negative Pressure Wound Therapy System DEVICE

RENASYS TOUCH NPWT System was administered to all participants.

Also known as: "RENASYS TOUCH NPWT" System

RENASYS TOUCH Negative Pressure Wound Therapy Device; RENASYS TOUCH Negative Pressure Wound Therapy System

Eligibility Criteria

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

You may qualify if:

• The patient is able to understand the study and is willing to consent to the study
• 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

You may not qualify if:

• Patients with a known history of poor compliance with medical treatment.
• 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
• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (2)

Tiervlei Trail Centre

Bellville, Cape Town, 7530, South Africa

Location

Dr Matley & Partners

Claremont, Cape Town, 7708, South Africa

Location

Related Publications (9)

• 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.

  PMID: 9188970 BACKGROUND

• 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.

  PMID: 9188971 BACKGROUND

• 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.

  PMID: 21316515 BACKGROUND

• 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.

  PMID: 21868296 BACKGROUND

• 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.

  PMID: 22119531 BACKGROUND

• 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.

  PMID: 23647737 BACKGROUND

• 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.

  PMID: 12398140 BACKGROUND

• 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.

  PMID: 16174508 BACKGROUND

• 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.

  PMID: 11189545 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Forlee, MD

  Dr Matley & Partners

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 1, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

ZA (2)