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CTRI Number  CTRI/2026/02/103597 [Registered on: 11/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing a dye based blood flow test with the surgeon assessment to prevent flap damage and complications after chest muscle flap surgery in patients with head and neck cancer. 
Scientific Title of Study   Evaluation of Indocyanine Green Angiography Versus Clinical Judgment in Reducing Flap Necrosis and Postoperative Morbidity in Pectoralis Major Myocutaneous Flap Reconstruction for Head and Neck Cancer A Randomized Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shridhar Hosamani 
Designation  Senior Resident 
Affiliation  AIIMS Mangalagiri 
Address  Department Of Surgical Oncology 4th Floor OPD Building AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  9582269645  
Fax    
Email  shri7dh@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemant Kumar Singh  
Designation  Assistant Professor  
Affiliation  AIIMS Mangalagiri 
Address  Room No 416 Department Of Surgical Oncology 4th Floor OPD Building AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  8903306321  
Fax    
Email  hemant.surgicaloncology@aiimsmangalagiri.edu.in   
 
Details of Contact Person
Public Query
 
Name  Dr Hemant Kumar Singh  
Designation  Assistant Professor  
Affiliation  AIIMS Mangalagiri 
Address  Room No 416 Department Of Surgical Oncology 4th Floor OPD Building AIIMS Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  8903306321  
Fax    
Email  hemant.surgicaloncology@aiimsmangalagiri.edu.in   
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Shridhar Hosamani 
Address  Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS Mangalagiri, Mangalagiri, 522503  
Type of Sponsor  Other [Principal Investigator ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shridhar Hosamani  AIIMS,Mangalagiri  Department Of Surgical Oncology 4th Floor OPD Building AIIMS Mangalagiri- 522503
Guntur
ANDHRA PRADESH 
9582269645

shri7dh@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, AIIMS MANGALAGIRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (2) ICD-10 Condition: C028||Malignant neoplasm of overlappingsites of tongue, (3) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (4) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (5) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, (6) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (7) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (8) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (9) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (10) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (11) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (12) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (13) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, (14) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (15) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clinical Judgment group   Patients in the control arm will undergo intraoperative and postoperative flap perfusion assessment based on clinical judgment alone, using conventional clinical parameters such as flap color, capillary refill, bleeding from flap edges, and temperature. No intraoperative ICG fluorescence assessment will be used. Standard postoperative monitoring will be done as per institutional protocol. 
Intervention  ICG-A group  Indocyanine green dye Aurogreen from Aurolab Madurai India twenty five milligram will be diluted in ten millilitre of distilled water. A dose of three millilitre corresponding to zero point two to zero point three milligram per kilogram body weight will be administered as a rapid intravenous bolus injection followed immediately by a ten millilitre normal saline jet flush. An ICG fluorescence imaging system SPY PHI from Stryker San Jose California United States will be used to obtain real time black and white fluorescent images of the PMMC flap to assess vascular perfusion. The camera will be positioned approximately twenty centimetre from the flap surface and the transit of dye through the flap vasculature will be observed and recorded. ICG fluorescence assessment will be performed in three phases. Phase one. After flap elevation. Phase two. After temporary flap rotation and fixation after tunnelling. Phase three. After final inset of the flap. A quantitative perfusion assessment of the PMMC flap will be performed by comparing fluorescence intensity with the baseline reference. A relative perfusion of more than thirty five percent of baseline will be considered indicative of adequate flap perfusion. Perfusion will be graded based on the time taken for dye visualization. Good perfusion is defined as dye visualization within thirty seconds. Moderate perfusion is defined as dye visualization between thirty to sixty seconds. Poor perfusion is defined as dye visualization after more than sixty seconds. Areas of the flap demonstrating poor perfusion will be identified based on fluorescence demarcation. These poorly perfused areas will be surgically revised along the line of demarcation and the size of the transected area will be measured and documented. The surgical team will interpret the ICG angiography findings and proceed with final reconstruction using only adequately perfused portions of the PMMC flap. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Age greater than eighteen years and less than seventy five years.
2.Histologically confirmed squamous cell carcinoma of the oral cavity.
3.Planned for PMMC flap reconstruction after resection.
4.No known allergy to iodides or ICG dye.
5.Willing to provide informed consent
 
 
ExclusionCriteria 
Details  1.Recurrent and Non-resectable head and neck cancers
2.Need for free flap reconstruction.
3.Prior chest wall surgeries or radiation.
4.Patient not fit for surgery
5.Patient not giving consent for participation in this study
6.Patients with diseases with poor healing rates and immunocompromised status
7.Known allergy to iodine or ICG.
8.severe hepatic dysfunction, pregnant/lactating women.

 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Flap-related complications- mainly partial necrosis
1. Flap dehiscence
2. Re-suturing
3. Re-Operations
4. Oro-Cutaneous fistula
 
30 days post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
1.Starting Orals

2.Hospital stays

3.Starting adjuvant Radiotherapy
 
2 Weeks, 4 weeks & before adjuvant RT  
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   02/03/2026 
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="6"
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
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (shri.7.dh@gmail.com).

  6. For how long will this data be available start date provided 31-08-2028 and end date provided 31-08-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Head and neck cancer surgeries often involve removing parts of the face or mouth and reconstructing them using tissue flaps. One commonly used technique in India is the pectoralis major myocutaneous (PMMC) flap, which is reliable and cost-effective. However, poor blood flow in parts of the flap can lead to serious complications such as tissue death, wound breakdown, infection, or the need for repeat surgery. These issues can delay recovery and postpone important treatments like radiotherapy.

Traditionally, surgeons assess flap blood supply during surgery using their clinical judgment—by checking color, bleeding, and temperature. These methods are highly subjective and depend on the surgeon’s experience. As a result, they sometimes fail to detect poorly perfused (low blood flow) areas of the flap.

This study introduces Indocyanine Green Fluorescence Angiography (ICG-A), a modern imaging technique that provides real-time, objective visualization of blood flow. ICG is a dye that, when injected into the bloodstream, fluoresces under infrared light. Using a specialized camera, surgeons can see exactly which areas of the flap have good or poor blood supply. This helps them make more accurate decisions about which tissue to keep and which to revise during the operation.

By comparing traditional methods with ICG-A in a randomized trial, this study aims to evaluate whether ICG-A can reduce complications, improve flap survival, and support faster postoperative recovery, such as earlier feeding, shorter hospital stays, and timely start of radiotherapy.

If successful, this research could help make surgeries safer and more effective, especially in Indian hospitals where PMMC flaps are commonly used, and lead to wider adoption of ICG technology in reconstructive cancer surgery.

 

 
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