Effect of Regulated Oxygen-Enriched Negative Pressure Therapy (RO-NPT) On Soft Tissue Wound Repair

• Conditions: Wounds and Injuries
• Interventions: Device: Wound treatment with RO-NPT; Device: Wound Irrigation

• Registration Number: NCT02357628
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT) will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal soft tissue wounds.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-05
• Last Update Submitted: 2015-02-05
• Study First Posted: 2015-02-06
• Last Update Posted: 2015-02-06
• Study Start: 2015-03
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with hard-to-heal wounds

Exclusion Criteria

• Everyone else

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Research Group III	Wound Irrigation	Wound treatment with RO-NPT 40% and irrigation
Research Group II	Wound treatment with RO-NPT	Wound treatment with RO-NPT 60%
Research Group I	Wound treatment with RO-NPT	Wound treatment with RO-NPT 40%
Research Group III	Wound treatment with RO-NPT	Wound treatment with RO-NPT 40% and irrigation

Primary Outcome Measures

Name	Time	Method
Wound Closure	One Month	Before treatment and after treatment wound area measurements will indicate percentage of closure

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel