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临床试验/CTRI/2026/02/104112
CTRI/2026/02/104112尚未招募不适用

A study on the effect of derotation on perforator flaps challenged with vascular compromise Randomised controlled trial

AIIMS1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年2月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS
入组人数
54
试验地点
1
主要终点
Increase in surface area of flap at day 10, in those whom intervention is done along with conventional treatment.

研究概览

简要总结

The study will include all perforator flaps having vascular compromise. The vascular compromise will be detected by clinical methods- colour, temperature, turgor, bleeding pattern and measuring blood sugar of flap (using glucometer).

The flap will be randomised to group A or B by means of computer-generated table of random numbers.  Group A will get conventional measures, namely, removal of sutures and loosening of local dressing, increase of local temperature, limb elevation, oral antiplatelet drugs (aspirin 75 mg). Group B will get conventional measures, namely, removal of sutures and loosening of local dressing, increase of local temperature, limb elevation, oral antiplatelet drugs (aspirin 75 mg), along with derotation of the flap. After 3 days, the derotated flap will be rotated into the defect. All flaps will be monitored every 6 hourly by clinical methods- colour, temperature, turgor, bleeding pattern and measuring blood sugar of flap (using glucometer). The person allocating the groups and performing the monitoring will be different from the operating surgeon.

At the end of 10 days, the surviving surface area of the flap will be measured using measuring scale and software available at https://www.sketchandcalc.com/area-calculator-app/. This will be done by a person different from the operating surgeon.

All relevant data will be collected and entered in the proforma. The data will then be tabulated using MS-Excel spreadsheet and appropriate statistical analysis will be done. SPSS 23 will be used, wherever required.

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
0.00 Day(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • Patients (or guardian) giving consent.
  • Perforator flap having vascular compromise.

排除标准

  • Patients not willing for followup.
  • Mentally unstable patient.

结局指标

主要结局

Increase in surface area of flap at day 10, in those whom intervention is done along with conventional treatment.

时间窗: day 10 after surgery

次要结局

  • Lesser need for secondary surgey, lesser morbidity, lesser pain, lesser hospital stay(Day 10)

研究者

发起方
AIIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shilpi Karmakar

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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