| 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 |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Effect Of Hyperbaric Oxygen Therapy On Uptake Of Skin Grafts
|
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Scientific Title of Study
|
Effect Of Hyperbaric Oxygen Therapy On Uptake Of Split Thickness Skin Grafts – A Randomised Control Trial
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| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
AIIMS |
| Address |
virbhadra road, shivaji nagar, near barrage,AIIMS rishikesh, 249203 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS RISHIKESH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T148||Other injury of unspecified body region, |
|
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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.
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|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Granulated traumatic wounds who underwent skin graft
|
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| 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
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Investigator Blinded |
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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 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To compare rate of epithelisation of the donor site of patients receiving HBOT verses the control group
|
10days |
|
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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" |
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Phase of Trial
|
N/A |
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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.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. |