Wound treatment clinical trial
Updated: Jan 29, 2019
Stiehl Tech will be conducting a clinical trial of its Perilav™ wound irrigation system. The objective of the study is to prove that daily wound irrigation can be done effectively outside of the hospital surgical operating room. Complex, often chronic wounds may have undergone surgical debridement and irrigations by the surgeon but now need continued daily wound irrigations. Limited anecdotal studies have proven that remarkable gains can be made in healing with this method, often in wounds where healing has stalled after many months of other treatments.
Under the Perilav™ clinical trial, treatments will be administered in the outpatient setting, such as in a nursing home, in a wound clinic or at the patient’s bedside. We believe the optimal course of treatment will require 30 treatments over 30 consecutive days. Treating clinicians will consult with the primary care physician in charge of the patient’s care and determine when the wound has stabilized and can be converted to simple daily dressings. At that point, the wound is near complete resolution and will soon close. Patients with very large wounds have been known to take up to 100 days for the wound to completely heal. Other patients whose wounds have stabilized may undergo tertiary reconstructive surgeries with skin grafts, etc., for final treatment.
Stiehl Tech will provide treatment materials to be used in the trial. The Stiehl Tech Perilav™ system consists of two main components: a handheld pulsatile irrigator and a fluid collection bag. The surgical irrigator is similar to surgical irrigation devices that have long been used by surgeons worldwide and that are the standard of care for irrigating wounds and open surgical sites. The fluid collection bag is an innovative mechanism to collect fluid used during treatment, floating wound debris and debris that may have been aerosolized during the course of treatment. Fluid collection bags will be provided for both extremity wounds as well as torso wounds. In addition to the fluid collection bag, the Perilav™ wound irrigation system contains several other components to prepare the wound site and to facilitate patient treatment.
The Perilav™ wound irrigation system investigational study is approved under the auspices of the Sterling Investigation Review Board (Atlanta, GA). No patients will be allowed to receive treatment with the Perilav™ wound irrigation system unless they participate in the clinical trial. Referrals may be made by physicians, nursing home staff, wound care nurses or therapists. All treatments must be authorized by the patient’s primary care physician or the physician directing the patient’s care.
There are no charges or fees for participating in the trial. The patient’s insurance may be billed for the medical devices and materials used in the study. The system is considered low risk and clinical staff will be trained in proper treatment techniques. The care of all patients participating in the study will be carefully documented in an anonymous database to determine the efficacy of the Perilav™ wound irrigation system. The protocol includes procedures to administer questionnaires, conduct periodic wound measurements and obtain wound photographs to document wound healing. Participation is strictly voluntary. Patients may withdraw from the study at any time.
Contact us to learn more or to request access to the clinical trial.