Procellera and Negative Pressure Therapy for Acute Wounds

NCT ID: NCT01938066

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-12-31

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.

Detailed Description

The study will consent 30 patients undergoing surgery through the abdominal wall and the skin incision will intentionally be left open. Subjects will be randomized using a random number generator. Each number will be placed in an envelope numbered 1-30. Arm 1 will be even numbers and Arm 2 will be odd numbers. A researcher not affiliated with the study will generate the numbers and place them in the envelopes. Arm 1 will place fifteen subjects on Negative Pressure Therapy Only and Arm 2 will place fifteen subjects on Negative Pressure and Procellera. Arm 1 (Negative Pressure Only) will have their dressing changed 3 times per week which is the standard of care for Negative Pressure Therapy. Arm 2 (Negative Pressure Therapy and Procellera) will have their dressing changed every 5 days. Arm 1 and 2 will have a tissue specimen taken on the 5th day only. The tissue will be taken from debrided material and sent for culture. The Negative Pressure Therapy Sponge, which is discarded after each dressing change, will be collected, lavaged with saline and the cells will be examined for macrophage function and the wound fluid will be tested for inflammation response. Photographs, wound measurements, pain scale and pain medication will also be completed at each dressing change. We will check the progress of the wound along with your surgeon during the subject's 30 day surgical follow up in the surgeon's office. The wound will be measured (if not healed), photograph's taken and their pain level assessed.

Conditions

Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Negative Pressure with Procellera

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.

Group Type: ACTIVE_COMPARATOR

Procellera

Intervention Type: DEVICE

bioelectric wound dressing

negative pressure therapy

Intervention Type: DEVICE

Negative Pressure Therapy only

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.

Group Type: SHAM_COMPARATOR

negative pressure therapy

Intervention Type: DEVICE

Interventions

Procellera

bioelectric wound dressing

Intervention Type: DEVICE

negative pressure therapy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years old that are undergoing abdominal wall surgery

Exclusion Criteria

• Below 18 years old and not having abdominal wall surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vomaris Innovations

INDUSTRY

Sponsor Role: collaborator

Gayle Gordillo

OTHER

Sponsor Role: lead

Responsible Party

Gayle Gordillo

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gayle M Gordillo, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

University Hosptial East

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2013H0028

Identifier Type: -

Identifier Source: org_study_id