Wang Dixin, Zhao Yan, Chang Qihang, Wang Peiru, Zhang Guolong, Wang Xiuli
Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China.
J Cosmet Dermatol. 2025 Sep;24(9):e70421. doi: 10.1111/jocd.70421.
To evaluate the clinical efficacy and safety of a novel skin wound dressing in promoting the repair of the ulcer wound after the treatment of Extramammary Paget's Disease (EMPD) with Hematoporphyrin Derivative Photodynamic Therapy (HpD-PDT).
A total of 10 patients with EMPD previously treated with HpD-PDT were recruited to conduct a self semi-lesion controlled study on the treatment of conformal dressing to evaluate the efficacy and safety of the skin ulcer wound repair therapy after HpD-PDT. The skin lesions treated with novel HVHA Shutai dressing were the study intervention group, and the skin lesions treated with standard of care were the control group. Parameters including skin lesion wound area and adverse events were collected and analyzed in both groups, and wound healing rates were calculated.
The mean total healing time of 10 subjects was 14.80 ± 3.36 weeks on the study intervention side and 18.30 ± 4.16 weeks on the control side. The total healing time of the study intervention side was significantly less than that of the control side (p = 0.009). The average healing rate of the test side was 85.28% ± 17.15% at Week 12, and that of the control side was 70.48% ± 23.20% at Week 12. The average healing rate of the study intervention side was significantly higher than that of the control side at Week 12 (p = 0.004). All skin lesions were completely healed at the end of follow-up. No adverse events such as dressing allergy, pain, or wound infection occurred in the subjects.
For skin wound care after HPD-PDT treatment of EMPD, HVHA Shutai dressing can accelerate wound healing, promote skin tissue and cell regeneration, and significantly shorten the time for complete wound healing of skin lesions, with significant effectiveness and acceptable safety.
评估一种新型皮肤伤口敷料在血卟啉衍生物光动力疗法（HpD-PDT）治疗乳腺外佩吉特病（EMPD）后促进溃疡伤口修复的临床疗效和安全性。
共招募10例先前接受过HpD-PDT治疗的EMPD患者，进行关于保形敷料治疗的自身半病变对照研究，以评估HpD-PDT后皮肤溃疡伤口修复治疗的疗效和安全性。采用新型HVHA舒泰敷料治疗的皮肤病变为研究干预组，采用标准护理治疗的皮肤病变为对照组。收集并分析两组的皮肤病变伤口面积和不良事件等参数，并计算伤口愈合率。
10名受试者在研究干预侧的平均总愈合时间为14.80±3.36周，在对照侧为18.30±4.16周。研究干预侧的总愈合时间明显短于对照侧（p = 0.009）。在第12周时，试验侧的平均愈合率为85.28%±17.15%，对照侧为70.48%±23.20%。在第12周时，研究干预侧的平均愈合率明显高于对照侧（p = 0.004）。所有皮肤病变在随访结束时均完全愈合。受试者未发生敷料过敏、疼痛或伤口感染等不良事件。
对于EMPD患者经HPD-PDT治疗后的皮肤伤口护理，HVHA舒泰敷料可加速伤口愈合，促进皮肤组织和细胞再生，显著缩短皮肤病变完全伤口愈合的时间，疗效显著且安全性可接受。
