Activated Carbon Interphase Effect on Surgical Incisions vs.Two Common Wound Dressings

Study Overview
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Brief Summary
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This randomized, prospective study evaluates incision closure, post-surgical wound complications, dressing changes, incision/scar appearance, pain associated with dressing changes, and patient satisfaction rates of an activated carbon dressing versus two commercially available wound dressings.

Detailed Description
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Postoperative incision complications and surgical site infections are risks for patients undergoing surgery. While most surgical incisions heal without complications, postoperative complications, such as erythema, blistering, maceration, scarring, necrosis, and infection, 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 exhibit the following characteristics: 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; act as a complete barrier to bacteria and water, but not to moisture vapor; and feature some flexibility to avoid restricted limb movement and postoperative edema in the incision area [Chen et al; Collins]. However, despite advances in wound dressing designs, there is no consensus regarding the ideal surgical incision dressing. One emerging dressing modality exhibits these key characteristics. This novel activated carbon cloth dressing is low-adherent, comprised of 100% pure activated carbon and also conforms to body contours to maintain contact with the incision surface. This randomized, prospective clinical trial will compare this activated carbon cloth dressing to two other commercially-available wound dressings, including a non-adherent antimicrobial alginate dressing with silver and a non-adhering knitted cellulose acetate mesh dressing soaked in Povidone-iodine. The primary endpoint is incision coaptation/closure. Secondary endpoints include incision/scar appearance, such as inflammation and edema, odor, pain, patient satisfaction, and number of dressing changes.

Official Title
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Activated Carbon Interphase Effect on Surgical Incisions Compared to Two Common Wound Dressings in a Prospective Randomized Control Trial

Conditions
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Surgical Wound, Healed

Intervention / Treatment
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* Device: Activated Carbon Cloth Dressing
* Device: Knitted Cellulose Acetate Mesh
* Device: Antimicrobial Alginate Dressing with Silver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are at least 18 years of age. Patients of both genders and all races. Patients undergoing primary, uni- or bilateral operative procedures of the forefoot, midfoot, non-heel posterior foot, ankle, and lower extremity and whose incisions are linear and at least 2 inches in length. Patients who are in good general health. Patients with no systemic or local active dermatologic disease, such as, but not limited to eczema, psoriasis, skin cancer, scleroderma, or chronic urticaria. Patients with vascular disorders must have been treated surgically to be considered for inclusion. Patients with diabetes must have ankle brachial index measurements greater than 0.6 to be considered for inclusion. Patients who have voluntarily signed the informed consent form, including HIPAA Authorization. Exclusion Criteria: Patients who are younger than 18 years of age. Patients undergoing operative procedures involving the heel or whose incisions are non-linear, such as those with curved arches or S configurations, and/or are less than 2 inches in length. Patients with previous operative procedure around the same area or joint. Patients with systemic or local active dermatologic disease, such as but limited to eczema, psoriasis, skin cancer, scleroderma, or chronic urticaria, that might interfere with surgical site evaluation. Patients with history of previous local infection. Patients with autoimmune conditions. Patients with known allergies or topical hypersensitivities to silver or any other components of the study dressings. Patients currently taking steroids or other immune modulators know to affect wound healing. Patients with vascular disorders that are non-interventional. Patients with diabetes who have ankle brachial index measurements less than 0.6 or lower extremities that are non-interventional or by-passable. Patients who are considered by the investigator for any reason to be an unsuitable candidate. Patients who are unwilling or unable to follow the follow-up evaluation schedules. Patients who refuse to voluntarily sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activated Carbon Dressing<br>A low-adherent, comprised of 100% pure activated carbon and also conforms to body contours to maintain contact with the incision surface. The dressing may be used either dry or moistened with sterilized water over dry or discharging, partial and full thickness wounds. | Device: Activated Carbon Cloth Dressing<br>* Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.<br>|
| Active Comparator: Knitted Cellulose Acetate Mesh<br>a non-adhering dressing, comprised of a knitted cellulose acetate mesh impregnated with a specially-formulated petrolatum emulsion. | Device: Knitted Cellulose Acetate Mesh<br>* Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.<br>|
| Active Comparator: Antimicrobial Alginate Dressing with Silver<br>a non-adherent antimicrobial alginate dressing with silver | Device: Antimicrobial Alginate Dressing with Silver<br>* Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision Closure | Complete re-epithelialization with no drainage | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Surgical Wound Complications | Presence of post-surgical wound complication(s) will be monitored | 8 weeks | 
| Incision Scar Appearance | Patient & Observer Scar Assessment Scale consists of 2 scales; one that the investigator completes and one that the subject completes. The investigator rates vascularization, pigmentation, thickness relief, and pliability on five 10-point numeric scales, with normal skin on the left pole and worst scar imaginable on the right pole. Patients rate their scar pain & itching, and scar appearance on six 10-point numeric scales, with no, no complaints on the left pole and yes, worst imaginable on the right pole. Individual items from both scales are summed with higher scores representing poorer scars and lower scores representing scars more closely resembling normal skin. The total score range of the observer scale component is 5 to 50. The total score range of the patient scale component is 6 to 60. The lowest scores, 5 and 6, respectively, reflect normal skin. | 8 weeks | 
| Number of Dressing Changes | The number of dressing changes will be counted by the investigator or study staff. | 8 weeks | 
| Wound odor | Patients will rate the odor of their wound using a Visual Analog Scale that consists of 10-cm(100-mm) line with the descriptor no odor positioned at the left pole and the descriptor extremely offensive odor positioned at the right pole. The lowest score, 0, reflects no wound odor, whereas a score of 10cm/100mm indicates extremely offensive wound odor. | 8 weeks | 
| Pain with Dressing Changes | Patients will rate their pain associated with the dressing changes using a Visual Analog Scale, as described by Springer BD et al, Am J Orthopedics, 2015. The Visual Analog Scale consists of a 10-cm (100-mm) line with the descriptor no pain positioned at the left pole and the descriptor worst pain imaginable positioned at the right pole. The lowest score, 0, reflects no pain, whereas a score of 10/100 indicates worst pain imaginable. | 8 weeks | 
| Patient Satisfaction | Patients will rate their satisfaction of their ability to perform activities of daily living, including ability to perform personal hygiene activities, ability to change clothes, ability to sit comfortably, and ability to sleep comfortably, using a Visual Analog Scales, as described by Springer et al, Am J Orthopedics, 2015. For each of the 4 satisfaction measures, patients will rate their satisfaction on the scale that consists of a 10-cm (100-mm) line, with the descriptor completely unsatisfied on the left pole and the descriptor completely satisfied on the right pole. These 4 satisfaction measures will be averaged for a composite satisfaction measure. An average score of 10/100 would indicate the patient is completely satisfied, whereas an average of 0 would indicate the patient is completely unsatisfied. | 8 weeks | 
| Ease of Dressing Changes | Investigator or study staff will rate the difficulty of the dressing changes using a Visual Analog Scale that consists of 10-cm(100-mm) line with the descriptor no difficulty positioned at the left pole and the descriptor extreme difficulty positioned at the right pole. The lowest score, 0, reflects no difficulty with dressing changes, whereas a score of 10cm/100mm indicates most difficulty with the dressing changes. | 8 weeks |