跳至主要内容
临床试验/CTRI/2020/10/028419
CTRI/2020/10/028419尚未招募不适用

Effect Of Hyperbaric Oxygen Therapy On Uptake Of Split Thickness Skin Grafts – A Randomised Control Trial

AIIMS1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年10月16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
64
试验地点
1
主要终点
compare the percentage of skin graft uptake on patients given hyperbaric oxygen therapy in immediate post op period compared to control group given standard care.

研究概览

简要总结

It is a well-known fact that sufficient oxygen supply and avoidance of wound infection is critical to healing process. The ischemic tissues heals poorly and get easily infected. Animal experimentations have shown that arterial hypoxia retards healing and also reduces tensile strength of the wound.Popular theory a decade ago has been that haemoglobin level should be maintained above 10g/dL to promote wound healing.2,3 As a result, some physicians and surgeons have been promoting blood transfusion to raise the haemoglobin level for better wound healing.

To achieve similar effect and improve oxygen perfusion, promote antimicrobial effect and promote neo-vascularization of the target site it was hypothesized that exposure to hyperbaric oxygen chamber could achieve better results. Rates of re-epithelisation (of the donor site) were also suggested to be affected positively by Hyperbaric Oxygen Therapy (HBOT) and thus included in study.

The success of a skin graft or its take depends on nutrient uptake and vascular in growth from the recipient bed. This occurs in three phases namely inflammatory response/plasmatic imbibitions, inosculation, angiogenesis and reinnervation. Proper skin graft dressing prevents graft mobility and seroma formation. Factors that affect take of graft include seroma or hematoma formation, poorly vascularized wound bed, contaminated bed, shearing of graft and lack of adequate tissue oxygen perfusion.4 Apart from these, cormobid conditions, some medicines like steroids, smoking and malnutrition affect take of graft.

In the first 48 h of grafting, the graft survives by “plasmatic imbibition.â€7 As discussed earlier, oxygen is the most critical needs of tissues. Improved oxygen availability contributes to better graft survival and engraftment. In the usual circumstances, this should not be necessary. However, in the compromised graft/bed, it may be invaluable. The benefit has been established in several animal and clinical studies.

Oxygen is vital for hydroxylation of lysine and proline residues during collagen synthesis and for cross linking and maturation of collagen which is required for strong wound healing.6 Lack of oxygen is corrected during HBOT, leading to adequate amounts of mature collagen formation.

HBOT works through both primary and secondary effects. Primary effects involve both increased pressure and hyperoxia by upto 20 times.Hyperoxygenation is an application of Henry’s law and results from an increase in dissolved oxygen in plasma as a result of increased partial pressure of arterial oxygen. A pressure of 3 ATA results in 6 ml of Oxygen being dissolved per 100 ml of plasma, thus rendering as much Oxygen delivery as by haemoglobin bound Oxygen.5Secondary effects as a result of a controlled oxidative stress include antimicrobial effects, blunting of ischemia–reperfusion injury, and wound healing. Wound healing is the result of both local and systemic effects.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Granulated traumatic wounds who underwent skin graft.

排除标准

  • Patient having :- pneumothorax, tympanic membrane perforation.
  • Patient is on bleomycin and doxorubicin drugs.

结局指标

主要结局

compare the percentage of skin graft uptake on patients given hyperbaric oxygen therapy in immediate post op period compared to control group given standard care.

时间窗: 10 days

次要结局

  • To compare rate of epithelisation of the donor site of patients receiving HBOT verses the control group

研究者

发起方
AIIMS
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验