A Randomized, Open-label, Multi-center, Controlled Clinical Study to Compare MAR-CUTIS With Dermabond Advanced in Closure of Surgical Incisions and Lacerations up to 15 Centimeters
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 38
- 主要终点
- Number of Participants With Total Dehiscence of Target Wound at Day 10
研究概览
简要总结
This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (<=)15 centimeter (cm). Eligible participants were randomized 2:1 to MAR-CUTIS or Dermabond Advanced.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For participants with surgical incisions:
- •Participants underwent closure of surgical incision 6 to 15 centimeters (cms) following laparotomy, abdominal hysterectomy, or laparoscopic intervention.
- •For participants with lacerations:
- •Participants requiring closure of a laceration on face (avoiding the immediate area around the eye) or extremities. In participants with multiple lacerations, one was selected as the target wound (i.e., greatest length and meets the study entry criteria).
- •For all participants:
- •Participant had given written informed consent/assent to participate.
- •Male and female participants at least 2 years of age and body weight 10 kilogram (kg) or greater.
- •Participants willing and capable of following instructions for wound care provided by the investigator and agreeing to return for all treatment control visits specified in this clinical study.
排除标准
- •For participants with lacerations:
- •Wounds on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips, eyes).
- •Wounds which might be regularly exposed to body fluids or with dense natural hair (e.g., scalp); wounds on ears.
- •Wounds on palms and feet.
- •Animal or human bites.
- •Lacerations that were heavily contaminated.
- •Punctured or crushed wounds.
- •Participants with lacerations having wound treatment more than 6 hours after the trauma.
- •For all participants:
- •Participants requiring suturing with sutures greater than 5 mm thickness.
- •Participants with documented skin disease or skin conditions (e.g., excessive hair at the site of surgery, scar tissue, wound, tattoo, coloration, or pre-existing open sores at the site of surgery that would interfere with the application of Investigational Medical Device or the skin assessment, as judged by the investigator).
- •Participant with any factors that might had an adverse effect on wound healing (e.g., previous history of keloid formation or hypertrophy [as well in the family]), history of immunosuppression, chronic systemic infection, or poor general health.
- •Participants with known blood clotting disorders.
- •Participants receiving steroids, immunosuppressants, chemotherapy, or anticoagulants.
- •Participants having known or suspected allergy or sensitivity to polyurethane, cyanoacrylates, formaldehyde, tapes or adhesives, or benzalkonium chloride.
- •Participant participating in any current clinical study with a non-CE ("Conformitee Europeene") marked device or investigational product.
- •Participant who was pregnant or breastfeeding.
- •Participant with history of a significant dermatologic disease or condition, such as atopic dermatitis, psoriasis, lichen ruber planus, vitiligo or conditions known to alter the skin appearance or physiologic response (e.g., decompensated diabetes mellitus, porphyria) that involves the investigative site.
- •Removal of Participants From Therapy or Assessments:
- •Only participants that were withdrawn from the study due to product failure at the time of application were replaced.
- •Participants might stop the study for any of the following reasons:
- •Participant request.
- •Use of non-permitted concurrent therapy.
- •Lost to follow-up (considered lost to follow-up only before Day 10).
- •Occurrence of adverse events not compatible with the continuation of participant participation in the study, in the investigator's opinion, or unacceptable to the participant to continue.
- •Investigator request.
- •Inter-current illness.
结局指标
主要结局
Number of Participants With Total Dehiscence of Target Wound at Day 10
时间窗: At Day 10
Wound dehiscence involved the breaking open of the surgical incision along the suture. Number of participants with dehiscence (reported as "yes") and number of participants showing no dehiscence (reported as "No").
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: From Baseline (Day 0) up to Month 3
A TEAE was defined as any adverse event (AE) that occured during the on-treatment-period (i.e. after the start of the application of the Investigational Medical Device (IMD) (Day 0) until the end-of-treatment visit \[Month 3\]).This included any events related to the procedures, the IMD, or the comparator. An SAE was any untoward medical occurrence or effect that: led to death, or led to serious deterioration in the health of the participant, that either resulted in: life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent, or impairment to a body structure or a body function. Or, led to fetal distress, fetal death, or a congenital abnormality or birth defect.
次要结局
- Number of Participants With Total Dehiscence of Target Wound at Month 1(At Month 1)
- Number of Participant's Reporting Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS)(At Month 1 and Month 3)
- Percentage of Participants With Wound Infections(At Day 10, and Month 1)
- Investigator's Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS)(At Month 1 and Month 3)
- Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale(At Day 10 and Month 1)
- Number of Participant Reporting Satisfaction With the Device Using a Product-Related Questionnaire(At Day 10 and Month 1)
- Number of Participants Reporting Satisfaction With the Device Evaluated by Investigator Using a Product-Related Questionnaire(At Day 0 and Month 1)
- Investigator's Satisfaction With Ease of Use With the Device Using a Product-Related Questionnaire(At Month 1)