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Clinical Trials/CTRI/2026/02/103597
CTRI/2026/02/103597Not yet recruitingNot Applicable

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

Dr Shridhar Hosamani1 site in 1 country110 target enrollmentStarted: March 2, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
110
Locations
1

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Investigators

Sponsor
Dr Shridhar Hosamani
Sponsor Class
Other [Principal Investigator ]
Responsible Party
Principal Investigator
Principal Investigator

Dr Shridhar Hosamani

AIIMS Mangalagiri

Study Sites (1)

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