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Role of Low Molecular weight Dextran in pedicled flap Reconstruction for oromandibular defects in patients of oral cavity malignancy

To study efficacy of Low molecular weight Dextran in pedicled flap Reconstruction for repair of oromandibular defect in patients with malignant lesions of oral cavity: A randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036147
Enrollment
44
Registered
2021-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C069- Malignant neoplasm of mouth, unspecified

Interventions

Intervention1: Dextran 40 infusion at 30ml/hour for 72 hours post operatively: Patients will be given test dose of Dextran-40 20 ml intraoperataively to check for anaphylactic reactions. If tolerating

Sponsors

Dr Zaid Shaikh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy proven patients with oral cavity malignancy, planned for surgical treatment and requiring reconstruction with pedicled flap will be included.

Exclusion criteria

Exclusion criteria: Age of the patients 70 years, patients with hemodynamic compromise, patient with history of previous cardiac or pulmonary complications like PAH, Pulmonary edema, Coronary artery disease with history of interventions.

Design outcomes

Secondary

MeasureTime frame
Hemodynamic parametersTimepoint: On POD 1 and before discharge;Post operative chest X-ray compared with pre-operative chest X-RayTimepoint: On post operative day 1;Post operative neck drain to be measured. If chest drain insitu that too has to be measured on every post operative dayTimepoint: On post operative day 1,2,3,4,5 until drain removal

Primary

MeasureTime frame
Flap survival status post operatively to be assessed and compared with intraoperative pictureTimepoint: Flap survival status post operatively will be assessed on POD1,3,5 and 7

Countries

India

Contacts

Public ContactDr Dillip Samal

AIIMS Bhubaneswar

ent_dillip@aiimsbhubaneswar.edu.in9438884168

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026