跳至主要内容
临床试验/CTRI/2025/10/096503
CTRI/2025/10/096503尚未招募4 期

Epidermal growth factor dressing in comparison to Collagen sheet dressing for Skin graft donor site wound

Aarupadai veedu medical college1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Epidermal growth factor dressing is better than Collagen sheet dressing in aspects of Wound healing time, Scar quality, Low chance of Surgical site infection.

研究概览

简要总结

After the clearance from the IRC and IEC, sampling of patients for Epidermal Growth Factor and Collagen sheet dressing done by Group Allocation concealment method during the study period mentioned, fulfilling the inclusion and exclusion criteria already listed above will be recruited for the study, after obtaining informed consent. The nature, purpose, and the roles in the study will be explained in detailed, including the information that their non-participation in the study would not affect the quality of the treatment that they are to receive and that they are free exit the study at any time. After assuring that their response would remain confidential, an informed written consent for the same shall be obtained from the all participants.

Patients will be randomized into two groups. This is done by Group Allocation Concealment Method (i.e) Patient has been separated randomly into two groups by single blinding technique as the investigator alone knows which patient is in which group.

Collagen sheet dressing and Epidermal Growth Factor dressing will be performed for both the groups. In one group Collagen sheet dressing and in the other group Epidermal Growth Factor dressing will be performed. Duration of wound healing, post operative complications has been evaluated. Donor site dressing will be opened only after 14 days of surgery. On Post operative day 2, 4 and 6 , I will measure pain of the patients using Pain score scale. On Post operative day 14, 1 st look of the donor site wound will be done and 2 nd look will be done on post op day 21 based on scar pigmentation (Normal /Hypopigmentation /Hyperpigmentation), scab formation, infection.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing split thickness skin grafting were included in the study.

排除标准

  • Hypersensitivity to collagen Infected donor site wound Uncontrolled diabetes Severe anemia and Hypoproteinemia Immunocompromised patients Mentally ill patients Malignancy, local irradiation Collagen vascular disease Patient refusal.

结局指标

主要结局

Epidermal growth factor dressing is better than Collagen sheet dressing in aspects of Wound healing time, Scar quality, Low chance of Surgical site infection.

时间窗: Assessing donor site wound on post operative day 14 and 21 for wound characteristics

But, Collagen sheet dressing is better in terms of Pain in comparison with Epidermal growth factor local applicantion.

时间窗: Assessing donor site wound on post operative day 14 and 21 for wound characteristics

次要结局

  • Assessment of pain over donor site wound on comparing epidermal growth factor and collagen sheet dressing(Post operative day 2, 4,6)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Amirtharaj N

Aarupadai veedu medical college

研究点 (1)

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