跳至主要内容
临床试验/CTRI/2025/11/097704
CTRI/2025/11/097704尚未招募2 期

Effectiveness of hyperbaric oxygen therapy as an adjuvant to conventional therapy in the salvage of compromised flaps: Randomized Controlled Study

Uttar Pradesh University Of Medical Sciences1 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30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1.Flap Surface Area: Each discolored surface area of flap will be measured by using manual planimetry before starting the treatment

研究概览

简要总结

Flap surgery remains a cornerstone of reconstructive procedures using skin grafts and flaps are essential for

restoring tissue integrity following trauma, chronic disease, surgical excision, or burns. However, despite

optimal planning and surgical technique, flap or graft failure may still occur due to factors such as ischemia,

venous congestion, or poor wound bed quality. These complications can result in delayed healing, additional

surgical interventions, increased healthcare costs, and psychosocial distress for patients.

.

Current treatment strategies for compromised grafts and flaps include local wound care, vacuum assisted

closure, surgical debridement, and additional reconstructive procedures. These are associated with increases

in healthcare- associated costs, patient discomfort, and may lead to additional donor site morbidity. Flap

surgeries widely used in reconstructive procedure to restore ischemic reperfusion resulting from trauma,

surgical excision or burns.

Hyperbaric oxygen therapy is an adjunctive treatment modality that deliver 100% oxygen at elevated

atmosphere pressure (1-2 ATA). It significantly increased dissolve oxygen in plasma due to elevated arterial

partial pressure of oxygen. Hyperbaric oxygen therapy provides administration of hyper oxygenation that

supports key process in wound healing, fibroblast proliferation, collagen synthesis, bacterial clearance by

generation of oxygen free radical. Its therapeutic benefits in restoring compromised flaps as it improves flap

viability & necrosis when surgical re-exploration reveals no correctable cause.

.

HBOT may help in saving tissues that are compromised and not healing properly. It promotes salvage of

compromised flaps or grafts and uncomplicated healing after ablative or reconstructive surgery. It has also

been used to improve ischemic wounds before skin grafting and to support ischemic flaps.

This thesis aim to assess the efficacy of HBOT in improving outcomes of compromised flaps. There are

studies for HBOT on effectiveness in restoring compromised flap but their is lack of direct study which

comparing HBOT as an adjuvant to conventional therapy in compromised flap in term of effectiveness.

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

  • American Society of Anesthesiology physical status 1 and 2 Patients with Compromised Flaps.

排除标准

  • Any disorders of active upper respiratory tract infection, any active lung pathology
  • Pregnant or breastfeeding females
  • Claustrophobic patients
  • Patients with diabetes or immunosuppressive diseases 5.CSOM or tympanic membrane perforation
  • Emphysema with CO2 retention
  • History suggestive of optic neuritis
  • History of spontaneous pneumothorax
  • History of thorax surgery
  • Seizure disorders
  • Uncontrolled high fever
  • Viral infections.

结局指标

主要结局

1.Flap Surface Area: Each discolored surface area of flap will be measured by using manual planimetry before starting the treatment

时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy

& after each session of HBOT

时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy

2.Temperature by thermometer

时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy

3.Turgor by palpation/skin pinch

时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy

4. Random Blood Sugar (RBS) by glucometre

时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy

5. Colour on prick by sterile needle

时间窗: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy

次要结局

  • Find healing time, hospital stay & complication rates in comparison to conventional flap(care in the management of compromised flaps)

研究者

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

Mohd Ali

Uttar Pradesh University Of Medical Sciences

研究点 (1)

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