Comparing the amount of blood loss and healing in cleft operations when using newer cutting tools such as Colorado tip with traditional methods such as surgical knife

COMPARISON OF COLORADO TIP AND CONVENTIONAL SCALPEL FOR BLOOD LOSS AND HEALING IN PRIMARY CLEFT PALATE SURGERY - A RANDOMISED CLINICAL TRAIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042056

Enrollment

Registered

2022-04-22

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-02

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: Colorado Microdissection Needle tip: Colorado Microdissection Needle tip for incisions in Primary cleft palate surgery Control Intervention1: Surgical Scalpel: Conventional Surgical Sca

Eligibility

Inclusion criteria

Inclusion criteria: Patient undergoing primary cleft palate repair surgery

Exclusion criteria

Exclusion criteria: 1. Cleft patients with associated syndromes 2. Medically compromised patients 3. Cleft palate revision surgery 4. Mentally retarded and uncooperative patients 5. History of systemic disease, CVS disease, Asthma, -Hypertension, Diabetes, Coagulopathy, Bleeding disorders, Vascular anomalies.

Design outcomes

Primary

Measure	Time frame
1.Total blood loss: Suction bottle, Gauze & Pre and post operative Hemoglobin measurement 2.Healing of wound: Southampton Wound grading system Timepoint: 1.Total blood loss: Suction bottle- baseline- during surgery, Gauze- during surgery & Pre and post operative Hemoglobin measurement- Before surgery and 1 day after surgery 2.Healing of wound: Southampton Wound grading system -Baseline, 7 days, 1 month and 3 months	—

Measure

Time frame

1.Total blood loss: Suction bottle, Gauze & Pre and post operative Hemoglobin measurement 2.Healing of wound: Southampton Wound grading system Timepoint: 1.Total blood loss: Suction bottle- baseline- during surgery, Gauze- during surgery & Pre and post operative Hemoglobin measurement- Before surgery and 1 day after surgery 2.Healing of wound: Southampton Wound grading system -Baseline, 7 days, 1 month and 3 months

—

Secondary

Measure	Time frame
Presence or absence of Palatal fistulaTimepoint: Presence or absence of Palatal fistula- Immediate post operative, after seven days, after one month, after three months.	—

Countries

India

Contacts

Public ContactDr Senthil Murugan Pandurangan

Saveetha Dental College and Hospital

senthilmuruganp.sdc@saveetha.com9790869469

Outcome results

None listed

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