Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization

Stopped early · Not applicable

Conditions studied: Wound Debridement

In brief

The purpose of this study is to determine if the use of HemCon chitosan-based dressings is effective to facilitate safe, effective debridement of chronic wounds in the operating room and inpatient ward settings and to minimize bacterial re-colonization of wounds.

Key facts

Study ID

NCT01035944

Run by

HemCon Medical Technologies, Inc

People needed

37

Starts

2010-02-01

Expected to finish

2012-03-01

Last updated by the study team

2014-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years and are able to provide written informed consent.
• Have a wound on their body with an eschar and/or significant slough present
• Documented laboratory studies and coagulation profiles prior to the debridement (including hematocrit, hemoglobin, white blood count, total lymphocyte count, albumin, pre-albumin, HbA1C in patients with diabetes)
• Subjects with a hemoglobin < 9 g/dL must have one unit of blood typed and cross matched prior to the debridement; all other subjects must have an active type and screen performed prior to the debridement procedure.
• Subjects must be willing to consent to a blood transfusion in the rare event that a transfusion is necessary.
• Must be expected to be inpatients for at least 5 days following debridement, to enable controlled dressing changes by the service.
• Female subjects of childbearing age must not be pregnant, and must consent to utilize an appropriate method of contraception during the course of the study.
• For subjects that are to undergo a debridement in the operating room:
• Subjects must be sensate or have wounds that are sufficiently large to warrant a debridement in the OR
• Wounds must require more than a simple eschar removal, or must be extensive enough that an operating room debridement would be more appropriate.
• Subjects must be candidates for regional or general anesthesia, unless the wound occurs in an insensate body part (for example, a pressure sore in a paraplegic or quadriplegic patient, or a diabetic foot ulcer in a patient with a dense diabetic polyneuropathy).
• For subjects that are to undergo a debridement in the bedside setting:
• The part of the wound that is to be debrided must be mostly an eschar and necrotic tissue which is not likely to have significant bleeding.
• Subjects must be insensate, or the wound must be less than 50 cm2 such that the use of local anesthesia in the wound can be undertaken.

You may not qualify if…

• Pre-debridement hemoglobin level < 7.0 g/dL
• Not candidates for or refuse blood transfusions
• Unable to provide written informed consent
• Subjects with sensitivity to chitosan or the gauze dressings used in this study, or any local anesthetic needed for a debridement
• Subjects who are in the intensive care unit
• Subjects who, in the opinion of the Investigator, may not complete the study for any reason.
• Have grossly infected wounds that may reasonably be expected to require multiple debridement procedures prior to clearance of bacteria and nonviable tissue from the wound.
• For wounds situated in the lower extremity, leg must have either palpable pulses or else an ABI > 0.4

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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