Patterned Electric Dressing Effects on Open Wounds

Amputation Clinical Trial

— PED  

Official title:

Patterned Electric Dressing Effects on Open Wounds

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04018469
• Other study ID #: 1807454805
• Status: Withdrawn
• Start date: April 2022
• Est. completion date: November 2023

Study information

• Verified date: April 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

1. This study is a pilot feasibility study to determine treatment effects to estimate sample size for future studies that evaluate wound bacteria colonization. 2. The secondary objective of this study aims to observe the effect of PED on an open wound and its effects in wound bacteria colonization.

Description:

This study is designed as a pilot study where 30 patients receiving a below the knee amputation with at least one open wound on the limb will be enrolled. Patients are identified through medical records. The patients will be selected based on inclusion and exclusion criteria through pre-screening through the Comprehensive Wound Center's Limb Preservation Program and wound physicians/providers at Indiana University. The decision of amputation is made independently of the study and is solely made by the patient and their physician/provider. The provider decides based on the severity of the limb's condition if/when the limb should be amputated and will schedule this surgery with the patient based on current clinical standard of care. Study participation is decided independent of clinical decision. Patients enrolled in the study will wear the Patterned Electric Dressing (PED) on the wound(s) for up to 3 weeks or until amputation, whichever comes first and will have up to a total of 4 study visits.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ages 18 years and older
• Patients identified to be receiving a non-traumatic below the knee amputation within 3 weeks of enrollment
• The affected limb to be amputated must have at least one open wound
• Wound(s) must be able to be covered by 3x3 dressing
• Subjects willing and able to provide informed consent

Exclusion Criteria:

• Pregnant women
• Prisoners
• Individuals lacking consent capacity

Related Conditions & MeSH terms

• Amputation
• Open Wound
• Wounds and Injuries

Intervention

Other:
• No Interventions
No Interventions

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Gayle Gordillo

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ammons MC, Ward LS, James GA. Anti-biofilm efficacy of a lactoferrin/xylitol wound hydrogel used in combination with silver wound dressings. Int Wound J. 2011 Jun;8(3):268-73. doi: 10.1111/j.1742-481X.2011.00781.x. Epub 2011 Apr 1. — View Citation

Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999 May 21;284(5418):1318-22. Review. — View Citation

Douglas LJ. Medical importance of biofilms in Candida infections. Rev Iberoam Micol. 2002 Sep;19(3):139-43. — View Citation

Schachter B. Slimy business--the biotechnology of biofilms. Nat Biotechnol. 2003 Apr;21(4):361-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial colonization & culture	Bacteria colonization (cultures results high, moderate, low or negative).	3 weeks or until amputation, whichever comes first
Primary	Necrotic tissue assessed through light microscopy of tissue biopsies	Hematoxylin and Eosin staining of tissue sections to measure extent of tissue necrosis at baseline and compared to tissue obtained at surgery after PED treatment.% necrotic tissue will be measured.	3 weeks or until amputation, whichever comes first
Secondary	Wound area measured before and after wound treatment	To determine the effect of PED on % wound closure based on wound measurements at baseline and end of PED treatment.	3 weeks or until amputation, whichever comes first
Secondary	Bacterial biofilm through Scanning Electron Microscopy analysis	Perform scanning electron microscopy to detect bacterial biofilm (high, moderate, low or negative) before and after PED treatment.	3 weeks or until amputation, whichever comes first
Secondary	Bacterial contamination assessed through Colony Forming Units	Colony forming units will be measured from tissue samples and dressings to quantitate bacterial contamination levels at baseline and after PED treatment.	3 weeks or until amputation, whichever comes first