Procellera and Negative Pressure Therapy for Acute Wounds

NCT01938066 | Completed Results DMC

• 1 other identifier: 2013H0028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if Procellera speeds wound healing. The study will examine colonization (bacterial growth), pain and pain medication and reduced cost of care by using Procellera (an antimicrobial agent) under Negative Pressure Therapy placed on the wound after abdominal wall surgery. Procellera is a single layer dressing that helps to kill germs that cause infections. Negative Pressure Therapy is a vacuum device with a sponge that is placed in your wound to help heal the wound faster.

Conditions

Wound

Keywords

procellera

Outcome Measures

Primary Outcomes (1)

• Wound Infection

  At the end of 5 days all subjects will get a Culture and Sensitivity to see if they have an infection or what type of infection they have in the wound

  At the end of 5 days

Secondary Outcomes (1)

• Amount of Pain Medication Used (Morphine)

  5 days

Study Arms (2)

Negative Pressure with Procellera

ACTIVE COMPARATOR

Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.

Device: Procellera; Device: negative pressure therapy

Negative Pressure Therapy only

SHAM COMPARATOR

Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.

Device: negative pressure therapy

Interventions

Procellera DEVICE

bioelectric wound dressing

Negative Pressure with Procellera

negative pressure therapy DEVICE

Negative Pressure Therapy only; Negative Pressure with Procellera

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old that are undergoing abdominal wall surgery

You may not qualify if:

• Below 18 years old and not having abdominal wall surgery

Sponsors & Collaborators

• Gayle Gordillo: lead
• Vomaris Innovations: collaborator

Study Sites (1)

University Hosptial East

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Gayle Gordillo
• Organization: The Ohio State University

gayle.gordillo@osumc.edu

6142938566

Study Officials

• Gayle M Gordillo, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 10, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 21, 2016
• Results First Posted: April 21, 2016

Record last verified: 2016-03

Locations

US (1)