Activated Carbon Interphase Effect on Surgical Incisions Compared to Two Common Wound Dressings in a Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Incision Closure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Activated Carbon Dressing
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.
干预措施: Activated Carbon Cloth Dressing (Device)
Knitted Cellulose Acetate Mesh
a non-adhering dressing, comprised of a knitted cellulose acetate mesh impregnated with a specially-formulated petrolatum emulsion.
干预措施: Knitted Cellulose Acetate Mesh (Device)
Antimicrobial Alginate Dressing with Silver
a non-adherent antimicrobial alginate dressing with silver
干预措施: Antimicrobial Alginate Dressing with Silver (Device)
结局指标
主要结局
Incision Closure
时间窗: 4 weeks
Complete re-epithelialization with no drainage
次要结局
- Number of Dressing Changes(8 weeks)
- Post-Surgical Wound Complications(8 weeks)
- Incision Scar Appearance(8 weeks)
- Patient Satisfaction(8 weeks)
- Ease of Dressing Changes(8 weeks)
- Wound odor(8 weeks)
- Pain with Dressing Changes(8 weeks)
研究者
Brock Liden, DPM
Principal Invesigator
Liden, Brock, DPM