A study comparing two methods of stopping bleeding from oral cavity graft harvest site in surgery for urethral narrowing

Randomized Controlled Trial Comparing Oxidized Regenerated Cellulose Hemostat (Surgicel ) with Conventional Oral Packing for Buccal Mucosal Graft Hemostasis in Primary Urethroplasty - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/098152

Enrollment

100

Registered

2025-11-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Oxidised Regenerated Cellulose (Surgicel ) Group: A Kilner-Doughty mouth retractor will be used to expose the cheek. The Stensen s duct will be identified and avoided. A full-thickness

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing primary urethroplasty requiring unilateral buccal mucosal graft, Graft size between 5 7 cm

Exclusion criteria

Exclusion criteria: History of oral malignancy, Active oral infection or inflammation, Poor oral hygiene or periodontal disease, Chronic tobacco use (smoking or chewing), History of previous urethral surgery, Systemic coagulopathies or active anticoagulant/antiplatelet use

Design outcomes

Primary

Measure	Time frame
To compare the incidence of postoperative bleeding, severity of bleeding and requirement of additional hemostatic interventions (surgical or pharmacological)following use of Oxidized Regenerated Cellulose Hemostat (Surgicel ) with Conventional Oral Packing with sterile gauze after harvest of buccal mucosal graft for primary urethroplastyTimepoint: Postoperative Day 0 to Day 30	—

Secondary

Measure	Time frame
To compare the pain at graft harvest site using Visual analogue scale, Donor site morbidity using the Oral Impacts on Daily Performance (OIDP) questionnaire following use of Oxidized Regenerated Cellulose Hemostat (Surgicel ) with Conventional Oral Packing with sterile gauze after harvest of buccal mucosal graft for primary urethroplastyTimepoint: Day 2, 1 week, 1 month, and 12 months ;To compare the healing status by clinical assessment, patient satisfaction and comfort with treatment approach using structured questionnaire, incidence of postoperative complications following use of Oxidized Regenerated Cellulose Hemostat (Surgicel ) with Conventional Oral Packing with sterile gauze after harvest of buccal mucosal graft for primary urethroplastyTimepoint: 1 week, 1 month, 3 months, 6 months, and 12 months	—

Measure

Time frame

To compare the pain at graft harvest site using Visual analogue scale, Donor site morbidity using the Oral Impacts on Daily Performance (OIDP) questionnaire following use of Oxidized Regenerated Cellulose Hemostat (Surgicel ) with Conventional Oral Packing with sterile gauze after harvest of buccal mucosal graft for primary urethroplastyTimepoint: Day 2, 1 week, 1 month, and 12 months ;To compare the healing status by clinical assessment, patient satisfaction and comfort with treatment approach using structured questionnaire, incidence of postoperative complications following use of Oxidized Regenerated Cellulose Hemostat (Surgicel ) with Conventional Oral Packing with sterile gauze after harvest of buccal mucosal graft for primary urethroplastyTimepoint: 1 week, 1 month, 3 months, 6 months, and 12 months

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Countries

India

Contacts

Public ContactDinesh M

Asian Institute of Nephrology and Urology

bhavatej@gmail.com9652342642

Outcome results

None listed

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