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CTRI Number  CTRI/2020/10/028419 [Registered on: 15/10/2020] Trial Registered Prospectively
Last Modified On: 15/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Hyperbaric Oxygen Therapy On Uptake Of Skin Grafts  
Scientific Title of Study   Effect Of Hyperbaric Oxygen Therapy On Uptake Of Split Thickness Skin Grafts – A Randomised Control Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nilesh Jagne 
Designation  senior resident 
Affiliation  AIIMS RISHIKESH 
Address  VIRBHADRA ROAD
SHIVAJI NAGAR
Dehradun
UTTARANCHAL
249203
India 
Phone    
Fax    
Email  nileshjagne@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nilesh Jagne 
Designation  senior resident 
Affiliation  AIIMS RISHIKESH 
Address  VIRBHADRA ROAD
SHIVAJI NAGAR
Dehradun
UTTARANCHAL
249203
India 
Phone    
Fax    
Email  nileshjagne@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nilesh Jagne 
Designation  senior resident 
Affiliation  AIIMS RISHIKESH 
Address  VIRBHADRA ROAD
SHIVAJI NAGAR
Dehradun
UTTARANCHAL
249203
India 
Phone    
Fax    
Email  nileshjagne@gmail.com  
 
Source of Monetary or Material Support  
AIIMS rishikesh 
 
Primary Sponsor  
Name  AIIMS 
Address  virbhadra road, shivaji nagar, near barrage,AIIMS rishikesh, 249203 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nilesh Jagne  AIIMS RISHIKESH  VIRBHADRA ROAD SHIVAJI NAGAR NEAR BARRAGE
Dehradun
UTTARANCHAL 
7507392288

nileshjagne@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T148||Other injury of unspecified body region,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  hyperbaric oxygen therapy  in study group hyperbaric oxygen therapy will be prescribed for two sessions of 1 hour each on 2nd and 3rd post-operative day. HBOT will be given with 100% oxygen using multiple place chamber, using standard precautions at pressure of 1.5 atmospheres and 2 atmospheres absolute on the 2nd and 3rd post-operative day, respectively, by skilled technician. The area of graft uptake, as a percentage of the total area grafted, will be calculated in the study group on 4th and 7th post-operative day using the same technique described above. Donor site epithelization will also be assessed on 5th and 10th post-operative day and classified based on percentage of area epithelized. 
Comparator Agent  standard care  in the control group graft dressing will be opened on 4th post op day to analyse graft take and photographed as described above. Further dressing change will be on 7th post-operative day and again photographed. Donor site dressing will be opened on 5th and 10th post-operative day and epithelisation will be assessed.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Granulated traumatic wounds who underwent skin graft
 
 
ExclusionCriteria 
Details  Patient having :- pneumothorax, tympanic membrane perforation. Patient is on bleomycin and doxorubicin drugs. Patient who are not get clearance from ENT and cardiology
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.
 
10 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare rate of epithelisation of the donor site of patients receiving HBOT verses the control group
 
10days 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.”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.

 
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