Clinical trial NCT04038671: Activated Carbon Interphase Effect on Surgical Incisions vs.Two Common Wound Dressings
Official title: Activated Carbon Interphase Effect on Surgical Incisions Compared to Two Common Wound Dressings in a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgical Wound, Healed
Lead sponsor: Liden, Brock, DPM
Sponsor class: INDIV
First posted: 2019-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incision Closure
timeFrame: 4 weeks
Secondary outcomes:
measure: Post-Surgical Wound Complications
timeFrame: 8 weeks
measure: Incision Scar Appearance
timeFrame: 8 weeks
measure: Number of Dressing Changes
timeFrame: 8 weeks
measure: Wound odor
timeFrame: 8 weeks
measure: Pain with Dressing Changes
timeFrame: 8 weeks
measure: Patient Satisfaction
timeFrame: 8 weeks
measure: Ease of Dressing Changes
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Circleville
country: United States
facility: Circleville Foot & Ankle, LLC
state: Ohio
city: Logan
country: United States
facility: Hocking Valley Community Hospital
state: Ohio
Study officials:
References:
citation: Chen KK, Elbuluk AM, Vigdorchik JM, Long WJ, Schwarzkopf R. The effect of wound dressings on infection following total joint arthroplasty. Arthroplast Today. 2017 Jul 3;4(1):125-129. doi: 10.1016/j.artd.2017.03.002. eCollection 2018 Mar.
citation: Collins A. Does the postoperative dressing regime affect wound healing after hip or knee arthroplasty? J Wound Care. 2011 Jan;20(1):11-6. doi: 10.12968/jowc.2011.20.1.11.
citation: Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
citation: Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.
citation: Kalinski CK, Schnepf M, Laboy D, HernandezL, Nusbaum J, McGrinder B, Comfort C, Alvarez OM. Effectiveness of a Topical Formulation Containing Metronidazole for Wound Odor and Exudate Control. Wounds. 2005;17(4):84-90.
citation: Langlois J, Zaoui A, Ozil C, Courpied JP, Anract P, Hamadouche M. Randomized controlled trial of conventional versus modern surgical dressings following primary total hip and knee replacement. Int Orthop. 2015 Jul;39(7):1315-9. doi: 10.1007/s00264-015-2726-6. Epub 2015 Mar 19.
citation: Springer BD, Beaver WB, Griffin WL, Mason JB, Odum SM. Role of Surgical Dressings in Total Joint Arthroplasty: A Randomized Controlled Trial. Am J Orthop (Belle Mead NJ). 2015 Sep;44(9):415-20.
citation: Tustanowski J. Effect of dressing choice on outcomes after hip and knee arthroplasty: a literature review. J Wound Care. 2009 Nov;18(11):449-50, 452, 454, passim. doi: 10.12968/jowc.2009.18.11.44985.