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

Surgical Wound Dehiscence Clinical Trial

— NPWT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565043
• Other study ID #: CT13/01
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: February 14, 2018
• Start date: April 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2018
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound Dehiscence
• Wound and Injuries
• Wounds and Injuries

Intervention

Device:
• RENASYS TOUCH Negative Pressure Wound Therapy System
RENASYS TOUCH NPWT System was administered to all participants.

Locations

Country	Name	City	State
South Africa	Tiervlei Trail Centre	Bellville	Cape Town
South Africa	Dr Matley & Partners	Claremont	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

South Africa, 

References & Publications (9)

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. — View Citation

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 Martínez 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. Review. — View Citation

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. — View Citation

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. — View Citation

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, Martínez 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. Review. — View Citation

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. — View Citation

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. — View 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. — View Citation

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, Martínez 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	The percentage change in wound area	To assess progress towards wound closure using the percentage change in wound area (cm2)	28 days
Secondary	The number of patients with a confirmed clinical infection or presenting with clinical signs of infection	Patients that have a confirmed clinical infection or the number of patients that present with clinical signs of infection in their reference wound	28 days
Secondary	The number of patients with the condition of their surrounding skin recorded as either Healthy, Fragile, Inflamed, Macerated, Dry and Flaky, or Other	To assess the condition of the patients surrounding skin	28 days
Secondary	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	To assess the patients level of pain on application and during therapy	28 days
Secondary	The study will monitor safety in use and will record and assess all adverse events that occur during the study		28 days
Secondary	The percentage change in wound volume	To assess progress towards wound closure using the percentage change in wound area (cm3)	28 days
Secondary	The percentage change in wound depth	To assess progress towards wound closure using the percentage change in wound depth (mm)	28 days