Clinical trial NCT02565043: The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic Wounds
Official title: A Prospective, Open, Multi-centre Study to Evaluate Clinical Efficacy, Functionality and Device Performance of a New Portable Negative Pressure Wound Therapy System (RENASYS TOUCH) in the Management of Acute, Sub-acute and Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound and Injuries
Surgical Wound Dehiscence
Keywords: Negative Pressure Wound Therapy
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The study will comprise a prospective, open-labeled, multi-center study to assess the clinical efficacy, functionality and device performance of the new portable negative pressure wound therapy system in the management of acute, sub-acute and chronic wounds.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: 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
timeFrame: 28 days
Secondary outcomes:
measure: 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
timeFrame: 28 days
measure: 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
timeFrame: 28 days
measure: The percentage change in wound area
timeFrame: 28 days
measure: The number of patients with a confirmed clinical infection or presenting with clinical signs of infection
timeFrame: 28 days
measure: The number of patients with the condition of their surrounding skin recorded as either Healthy, Fragile, Inflamed, Macerated, Dry and Flaky, or Other
timeFrame: 28 days
measure: To record the patients level of pain using a 10-point pain scale, on application and during therapy, in patient's wounds that are randomised to intermittent or continuous therapy mode
timeFrame: 28 days
measure: The study will monitor safety in use and will record and assess all adverse events that occur during the study
timeFrame: 28 days
measure: The percentage change in wound volume
timeFrame: 28 days
measure: The percentage change in wound depth
timeFrame: 28 days
Other outcomes:
Locations:
city: Bellville
country: South Africa
facility: Tiervlei Trail Centre
state: Cape Town
city: Claremont
country: South Africa
facility: Dr Matley & Partners
state: Cape Town
Study officials:
affiliation: Dr Matley & Partners
name: Martin Forlee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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