NCT04038671

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brock Liden, DPM · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Wound, Healed

Interventions

Type	Name	Description
DEVICE	Activated Carbon Cloth Dressing	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.
DEVICE	Knitted Cellulose Acetate Mesh	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.
DEVICE	Antimicrobial Alginate Dressing with Silver	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.

Timeline

• Start date: 2019-01-07
• Primary completion: 2020-01-01
• Completion: 2020-02-01
• First posted: 2019-07-31
• Last updated: 2020-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study