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

Smith & Nephew

Status

Completed

Conditions

Wound and Injuries

Surgical Wound Dehiscence

Treatments

Device: RENASYS TOUCH Negative Pressure Wound Therapy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02565043

CT13/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.