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Clinical Trials/CTRI/2025/08/092908
CTRI/2025/08/092908Not yet recruitingPhase 4

Negative versus neutral drainage systems in patients following head and neck surgery- A randomised control study

All India Institute of Medical Sciences New Delhi1 site in 1 country96 target enrollmentStarted: September 1, 2025Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
96
Locations
1
Primary Endpoint
Immediate postoperative quality of life in neutral and negative suction groups

Study Overview

Brief Summary

Surgical drains are now a routine part of postoperative management in major head and neck surgeries. Based on their mechanism of action, drains are broadly classified into negative pressure (active suction) systems and neutral pressure (passive or gravity-based) systems. While negative suction drains are considered effective in reducing fluid collections, minimising dead space, and possibly decreasing infection risk, their application in complex oral cancer surgeries—where tissue integrity is delicate and direct communication with the aero-digestive tract is common—remains debatable. In surgeries involving communication between the oral cavity and neck, or where only thin tissue layers separate compartments, negative pressure drains may pose risks such as tissue compression, microvascular compromise, and suture line dehiscence. Our study aims to address this gap by comparing postoperative hospital course and outcomes in two groups of patients managed with either negative or neutral drainage systems

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Adult patients with age 18 to 60 years 2 Patients with oral and oropharyngeal malignancies anticipated to have neck communication during resection 3 Parents willing to sign informed consent.

Exclusion Criteria

  • 1 Patients with early stage malignancies where oral and oropharyngeal parts will not be communicated with neck 2 Patients with other site malignancies 3 Prior radio or chemotherapy.

Outcomes

Primary Outcomes

Immediate postoperative quality of life in neutral and negative suction groups

Time Frame: drain output will be measured on day 1, 2, 3, 4, 5, 6, 7 and 8 postoperatively

Secondary Outcomes

  • Postoperative complications in the negative & neutral suction groups.(will be seen on postoperative day 1, day 8 & day 14)

Investigators

Sponsor
All India Institute of Medical Sciences New Delhi
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Hitesh Verma

All India Institute of Medical Sciences, New Delhi

Study Sites (1)

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