Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds

NCT01500746 | Completed Results

• 1 other identifier: STU00057288
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.

Conditions

Chronic Wounds

Keywords

chronic wound treatment; pulse lavage; serial pulse lavage; wounds; bacterial colonization of wounds

Outcome Measures

Primary Outcomes (2)

• Change in Bacterial Counts

  A punch biopsy of the wound will be taken once the subject is enrolled in the study. A repeat biopsy will be taken after the 8th lavage treatment or the 8th dressing change. These will be sent for bacterial count analysis and the difference in bacterial counts will be evaluated. The lavage fluid from baseline measurements will be filtered and sent for bacterial counts and will be compared to the filtered fluid from the last lavage treatment. In addition, surface swabs will be taken at the beginning and end of the study and will be sent for bacterial counts as well. Bacterial counts from these lavage, biopsy specimen, and swabs will be averaged and analyzed.

  Baseline and at 4 days

• Change in Gene Expression Analysis

  A punch biopsy will be taken at the beginning of the study. this will be sent for gene expression analysis. A repeat biopsy at the end of the study will also be sent at the end of the study, and a change in gene expression in analysis will be evaluated.

  4 days

Secondary Outcomes (1)

• Pain With Lavage Treatments

  4 days

Study Arms (2)

Lavage arm

EXPERIMENTAL

This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.

Procedure: Pulse lavage treatment

Moist dressings

ACTIVE COMPARATOR

This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.

Other: Dressing changes

Interventions

Pulse lavage treatment PROCEDURE

A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments).

Also known as: Pulsed lavage (Stryker Pulsavac Plus), Wound containment apparatus

Lavage arm

Dressing changes OTHER

Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).

Moist dressings

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a chronic wound (as defined by the wound being present for \>30 days) located on any part of their body
• The wound must be smaller than 10cm in greatest diameter.
• Patients must have an expected remaining hospital duration of 4 days
• Patients must be willing and able to comply with all study procedures

You may not qualify if:

• Patients must not have undergone any surgical excisions or debridements of the wound in the past 30 days
• The wound may not undergo any surgical procedures or other treatments other than the study treatments during the course of the study.
• The wound may not require any immediate surgical intervention or debridement
• Patients may not start any new antibiotic therapy during the course of the study
• Must not have an allergy to skin adhesives.
• Patients must not be taking any immunosuppressive medications.
• Subjects who, in the opinion of the investigator, may not complete the study for any reason.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

• Brown LL, Shelton HT, Bornside GH, Cohn I Jr. Evaluation of wound irrigation by pulsatile jet and conventional methods. Ann Surg. 1978 Feb;187(2):170-3. doi: 10.1097/00000658-197802000-00013.

  PMID: 343735 BACKGROUND

• Granick MS, Tenenhaus M, Knox KR, Ulm JP. Comparison of wound irrigation and tangential hydrodissection in bacterial clearance of contaminated wounds: results of a randomized, controlled clinical study. Ostomy Wound Manage. 2007 Apr;53(4):64-6, 68-70, 72.

  PMID: 17449917 BACKGROUND

• Kuehn BM. Chronic wound care guidelines issued. JAMA. 2007 Mar 7;297(9):938-9. doi: 10.1001/jama.297.9.938. No abstract available.

  PMID: 17341696 BACKGROUND

• Svoboda SJ, Bice TG, Gooden HA, Brooks DE, Thomas DB, Wenke JC. Comparison of bulb syringe and pulsed lavage irrigation with use of a bioluminescent musculoskeletal wound model. J Bone Joint Surg Am. 2006 Oct;88(10):2167-74. doi: 10.2106/JBJS.E.00248.

  PMID: 17015593 BACKGROUND

• Keblish DJ, DeMaio M. Early pulsatile lavage for the decontamination of combat wounds: historical review and point proposal. Mil Med. 1998 Dec;163(12):844-6.

  PMID: 9866365 BACKGROUND

• Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300. No abstract available.

  PMID: 10696155 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Dr. Elliot Hirsch
• Organization: Northwestern University

elliot-hirsch@md.northwestern.edu

312-695-6022

Study Officials

• Robert D Galiano, MD

  Northwestern 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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: December 28, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 14, 2014
• Results First Posted: April 14, 2014

Record last verified: 2014-03

Locations

US (1)