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

NCT ID: NCT01500746

Last Updated: 2014-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-10-31

Brief Summary

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

Detailed Description

Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The major drawback to pulse irrigation is that it is extremely messy and can easily contaminate the patient's surroundings, putting other patients and the person operating the device at risk. In order to obtain the benefits of pulse lavage, we have created a device that will contain the water spray from the lavage and protect both the patient and their surroundings. Due to the fact that frequent (multiple times daily) pulse lavage therapy has not been possible previously, it is unknown how effectively serial pulse lavage irrigation reduces bacterial counts. This study evaluates the effectiveness of serial pulse lavage therapy in decreasing bacterial counts in chronic wounds.

Conditions

Chronic Wounds

Study Design

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

Study Groups

Lavage arm

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.

Group Type: EXPERIMENTAL

Pulse lavage treatment

Intervention Type: 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).

Moist dressings

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.

Group Type: ACTIVE_COMPARATOR

Dressing changes

Intervention Type: OTHER

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

Interventions

Pulse lavage treatment

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).

Intervention Type: PROCEDURE

Dressing changes

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

Intervention Type: OTHER

Other Intervention Names

Pulsed lavage (Stryker Pulsavac Plus); Wound containment apparatus

Eligibility Criteria

Inclusion Criteria

1. Patients must have a chronic wound (as defined by the wound being present for >30 days) located on any part of their body

2. The wound must be smaller than 10cm in greatest diameter.

3. Patients must have an expected remaining hospital duration of 4 days

4. Patients must be willing and able to comply with all study procedures

Exclusion Criteria

1. Patients must not have undergone any surgical excisions or debridements of the wound in the past 30 days

2. The wound may not undergo any surgical procedures or other treatments other than the study treatments during the course of the study.

3. The wound may not require any immediate surgical intervention or debridement

4. Patients may not start any new antibiotic therapy during the course of the study

5. Must not have an allergy to skin adhesives.

6. Patients must not be taking any immunosuppressive medications.

7. Subjects who, in the opinion of the investigator, may not complete the study for any reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Robert Galiano

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert D Galiano, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 343735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17449917 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17341696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17015593 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9866365 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10696155 (View on PubMed)

Other Identifiers

STU00057288

Identifier Type: -

Identifier Source: org_study_id