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The funding sponsor decided to move in a different direction and terminated the study before site began patient recruitment.
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activated Carbon Dressing | Experimental | 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. |
|
| Knitted Cellulose Acetate Mesh | Active Comparator | a non-adhering dressing, comprised of a knitted cellulose acetate mesh impregnated with a specially-formulated petrolatum emulsion. |
|
| Antimicrobial Alginate Dressing with Silver | Active Comparator | a non-adherent antimicrobial alginate dressing with silver |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated Carbon Cloth Dressing | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incision Closure | Complete re-epithelialization with no drainage | 4 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Circleville Foot & Ankle, LLC | Circleville | Ohio | 43113 | United States | ||
| Hocking Valley Community Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29560407 | Background | 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. | |
| 21278635 | Background | 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. |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
| Knitted Cellulose Acetate Mesh | Device | 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. |
|
| Antimicrobial Alginate Dressing with Silver | Device | 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. |
|
| 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 |
| Logan |
| Ohio |
| 43138 |
| United States |
| 15253184 | Background | 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. |
| 14622683 | Background | 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. |
| Background | 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. |
| 25787680 | Background | 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. |
| 26372751 | Background | 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. |
| 19901873 | Background | 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. |