| CTRI Number |
CTRI/2025/11/097704 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness of high pressure oxygen treatment as an adjuvant to conventional treatment vs conventional treatment alone in compromised flap patients |
|
Scientific Title of Study
|
Effectiveness of hyperbaric oxygen therapy as an adjuvant to conventional
therapy in the salvage of compromised flaps: Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Ali |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
Department Of Anaesthesiology and critical care
Uttar Pradesh University Of Medical Sciences
Saifai
Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7037923253 |
| Fax |
|
| Email |
mali786etw@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atit Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
Department Of Anaesthesiology and critical care
Uttar Pradesh University Of Medical Sciences
Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9453471671 |
| Fax |
|
| Email |
dr_atit@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Ali |
| Designation |
Junior |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
Department Of Anaesthesiology and critical care
Uttar Pradesh University Of Medical Sciences
Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7037923253 |
| Fax |
|
| Email |
mali786etw@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University Of Medical Sciences |
| Address |
Department Of Anaesthesiology
Saifai ,Etawah , Uttar Pradesh
Pincode 206130 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MOHD ALI |
Uttar Pradesh University Of Medical Sciences |
Department Of Anaesthesiology
Saifai ,Etawah , Uttar Pradesh
Pincode 206130
Etawah
UTTAR PRADESH |
7037923253
mali786etw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue, (3) ICD-10 Condition: S810||Open wound of knee, (4) ICD-10 Condition: S818||Open wound of lower leg, (5) ICD-10 Condition: S614||Open wound of hand, (6) ICD-10 Condition: S518||Open wound of forearm, (7) ICD-10 Condition: S710||Open wound of hip, (8) ICD-10 Condition: S711||Open wound of thigh, (9) ICD-10 Condition: T817||Vascular complications following aprocedure, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Treatment Alone |
Conventional treatment of compromised flaps includes local wound care, vacuum assisted closure, surgical debridement. |
| Intervention |
Hyperbaric Oxygen Therapy |
5 sessions of Hyperbaric oxygen therapy will be administered to patients of compromised flaps with conventional therapy first week, and if recovery is observed then another 5 sessions of 60 minutes will be continued for the next
week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiology physical status 1 and 2
Patients with Compromised Flaps. |
|
| ExclusionCriteria |
| Details |
1. Any disorders of active upper respiratory tract infection, any active
lung pathology
2. Pregnant or breastfeeding females
3. Claustrophobic patients
4. Patients with diabetes or immunosuppressive diseases
5.CSOM or tympanic membrane perforation
6. Emphysema with CO2 retention
7. History suggestive of optic neuritis
8. History of spontaneous pneumothorax
9. History of thorax surgery
10. Seizure disorders
11. Uncontrolled high fever
12. Viral infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Flap Surface Area: Each discolored surface area of flap will be measured by using manual planimetry before starting the treatment
& after each session of HBOT
2.Temperature by thermometer
3.Turgor by palpation/skin pinch
4. Random Blood Sugar (RBS) by glucometre
5. Colour on prick by sterile needle |
Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Find healing time, hospital stay & complication rates in comparison to conventional flap
care in the management of compromised flaps |
Healing time,hospital stay & complication rates will find after doing cases |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mali786etw@gmail.com].
- For how long will this data be available start date provided 05-05-2027 and end date provided 05-05-2075?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
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. |