A Prospective Randomized Controlled Trial Comparing Postoperative Incision Closure Rates, Patient Satisfaction, and Complications Between Activated Carbon Cloth Dressing and Two Standard Dressings After Foot/Ankle Procedures

Background: Postoperative wound complications and surgical site infections are risks for patients undergoing surgery.  While most surgical wounds heal without complications, postoperative complications, such as erythema, blistering, maceration, scarring, necrosis, and infection, will interfere with the normal healing process. Preventing such complications must be a priority, as they may contribute to longer recovery times, as well as increased hospital stays, costs, and morbidity. Ideally, surgical incision dressings should promote a moist environment; be absorbent, but transparent so fluid accumulation and other complications may be observed; be permeable; be low adherent to facilitate removal from skin; and act as a complete barrier to bacteria and water, but not to moisture vapor. Some flexibility to avoid restricted limb movement and postoperative edema in the wound area also is important. Despite advances in wound dressing designs, there is no consensus regarding the ideal surgical incision dressing.

Purpose: The purpose of this prospective, randomized, controlled study with IRB approval is to compare an activated carbon cloth dressing that exhibits the above characteristics to standard-of-care wound dressings, including a non-adherent antimicrobial alginate dressing with silver and a non-adhering knitted cellulose acetate mesh dressing soaked in Povidone-iodine.  

Methods: Enrollment of 24 subjects (8 in each study group) undergoing primary foot, ankle, and lower extremity operative procedures is underway.  Patients are being followed weekly for four weeks or until incision closure is achieved, whichever occurs first. Dressings are changed at each visit to assess for incision closure and post-surgical wound complications. The primary endpoint is incision closure. Secondary endpoints include inflammation, edema, odor, pain, incision/scar appearance, patient satisfaction, and number of dressing changes. Interim and final statistical analyses will be performed.

Predicted Results: It is anticipated that the use of the activated carbon cloth dressing will be associated with faster incision closure, higher patient satisfaction, and potential secondary benefits.

*Poster is not available at this time.