To compare the effectiveness of high pressure oxygen treatment as an adjuvant to conventional treatment vs conventional treatment alone in compromised flap patients

Effectiveness of hyperbaric oxygen therapy as an adjuvant to conventional therapy in the salvage of compromised flaps: Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097704

Enrollment

Registered

2025-11-19

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 Health Condition 2: L768- Other intraoperative and postprocedural complications of skin and subcutaneous tissue Health Condition 3: S810- Open wound of knee Health Condition 4: S818- Open wound of lower leg Health Condition 5: S614- Open wound of hand Health Condition 6: S518- Open wound of forearm Health Condition 7: S710- Open wound of hip Health Condition 8: S711- Open wound of thigh Health Condition 9: T817- Vascular complications following aproced

Interventions

Intervention1: Hyperbaric Oxygen Therapy: 5 sessions of Hyperbaric oxygen therapy will be administered to patients of compromised flaps with conventional therapy first week, and if recovery is observe

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiology physical status 1 and 2 Patients with Compromised Flaps.

Exclusion criteria

Exclusion criteria: 1. Any disorders of active upper respiratory tract infection, any active lung pathology 2. Pregnant or breastfeeding females 3. Claustrophobic patients 4. Patients with diabetes or immunosuppressive diseases 5.CSOM or tympanic membrane perforation 6. Emphysema with CO2 retention 7. History suggestive of optic neuritis 8. History of spontaneous pneumothorax 9. History of thorax surgery 10. Seizure disorders 11. Uncontrolled high fever 12. Viral infections

Design outcomes

Secondary

Measure	Time frame
Find healing time, hospital stay & complication rates in comparison to conventional flap care in the management of compromised flapsTimepoint: Healing time,hospital stay & complication rates will find after doing cases	—

Primary

Measure	Time frame
1.Flap Surface Area: Each discolored surface area of flap will be measured by using manual planimetry before starting the treatment & after each session of HBOT 2.Temperature by thermometer 3.Turgor by palpation/skin pinch 4. Random Blood Sugar (RBS) by glucometre 5. Colour on prick by sterile needleTimepoint: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy	—

Measure

Time frame

1.Flap Surface Area: Each discolored surface area of flap will be measured by using manual planimetry before starting the treatment & after each session of HBOT 2.Temperature by thermometer 3.Turgor by palpation/skin pinch 4. Random Blood Sugar (RBS) by glucometre 5. Colour on prick by sterile needleTimepoint: Analysis of healing compromised flap will be done after 1 week (5 sessions) and 2 weeks of hyperbaric oxygen therapy

—

Countries

India

Contacts

Public ContactDr Mohd Ali

Uttar Pradesh University Of Medical Sciences

dr_atit@rediffmail.com9453471671

Outcome results

None listed

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