Phase II clinical trial evaluating the safety and efficacy of a tissue engineered autologous skin substitute reconstructive surgery for basal cell carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Safety: adverse events and adverse reactions, including complications and sequelae in the healing of the surgical injury, making a distinction between early sequelae (hematoma, infection, blistering and graft loss) and late sequelae (necrosis, inflammation, granulation, abnormal healing, retractions, residual ulcers, pigmentation disorders...). Safety variables will be measured both in the surgical lesion and in the donor area, when applicable.
研究概览
简要总结
Safety: To confirm that the use of nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid is safe, based on the incidence of adverse events related to the investigational products, both during their implantation, as during subsequent follow-up. Feasibility: To verify that the surgical implant with nanostructured autologous artificial skin based on a fibrin matrix combined with agarose or hyaluronic acid is feasible in terms of its suturability and ability to attach to the recipient tissue, maintain its integrity and facilitate the re-epithelialization of the surgical wound.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients that give their informed consent for study participation.
- •Adult (18 years of age or older), of any sex and racial origin.
- •Clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps.
- •Namely, indication for Mohs surgery.
- •Women with childbearing age or men capable of producing a child, should commit to use contraceptives of medically proven efficacy.
排除标准
- •Locally advanced basal cell carcinoma with evidence of deep tissue infiltration (fascia, muscle…).
- •Coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up.
- •Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.
- •Lesions in the face., except for frontal-lateral area and the temple.
- •Injuries requiring urgent surgical intervention.
- •Infected, necrotic, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft.
- •Injuries that have received treatment with radiotherapy.
- •Contraindication for Mohs surgery.
- •Known allergies to antibiotics that could be part of the impurities in the PHA manufacturing process (gentamicin and amphotericin B).
- •Pregnant or breastfeeding women.
- •Coagulation disorders that make the healing process of the injury difficult.
结局指标
主要结局
Safety: adverse events and adverse reactions, including complications and sequelae in the healing of the surgical injury, making a distinction between early sequelae (hematoma, infection, blistering and graft loss) and late sequelae (necrosis, inflammation, granulation, abnormal healing, retractions, residual ulcers, pigmentation disorders...). Safety variables will be measured both in the surgical lesion and in the donor area, when applicable.
Safety: adverse events and adverse reactions, including complications and sequelae in the healing of the surgical injury, making a distinction between early sequelae (hematoma, infection, blistering and graft loss) and late sequelae (necrosis, inflammation, granulation, abnormal healing, retractions, residual ulcers, pigmentation disorders...). Safety variables will be measured both in the surgical lesion and in the donor area, when applicable.
Feasibility: surgical suturability, and ability to grasp/adhere to the recipient tissue in the first healing, maintain its integrity and facilitate re-epithelialization of the surgical wound.
Feasibility: surgical suturability, and ability to grasp/adhere to the recipient tissue in the first healing, maintain its integrity and facilitate re-epithelialization of the surgical wound.
次要结局
- Economic evaluation: A set of variables will be measured with the objective of comparatively analyzing the efficiency of the three types of treatments used in the clinical trial.
- Efficacy: Percentage of epithelialization of the lesion 3 weeks after the intervention, time until removal of stitches, time until complete epithelialization. Degree of pain (based on a visual analogue scale and analgesic use data). Aesthetic appearance of the lesion according to the POSAS scale (Van de Kar AL, 2005). Quality of life according to the DLQI indices (Finlay AY, 1994) and the SCI (Rhee JS, 2006; Rhee JS, 2007). Rescue surgeries performed.
- Efficacy: Complementarily, a set of structural characteristics, molecular and functional properties of the skin will be measured in the surgical injury using different study techniques: doppler ultrasound, cutaneous homeostasis study, histological tests of skin biopsies using optical microscopy.
研究者
Gloria Carmona Sánchez
Scientific
Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud