Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.

Phase 3Active Not RecruitingNCT05185115

Nantes University Hospital200 enrolled

Overview

Ankle fractures are one of the most common surgeries in the world. After this kind of surgery, complications can occur, related to the scar or an infection. These complications are more frequent in "high-risk" patients. Nasal oxygen therapy is currently used in order to reduce these complications. However, no study proved its efficiency yet. In a cohort of 200 patients, one group will receive oxygen therapy during hospitalization, while the other will not. Complication rates will be observed up to 6 months after the operation

Prospective, single-center, comparative and randomized study based on a cohort of 200 patients with an ankle fracture. The patients will be assigned to one of the following group: with or without oxygen therapy. Patients in the experimental group will receive the oxygen just before the operation, and during the hospitalization. The rest of the care is the same for the 2 groups. Comparison of complication rate, of quality of healing, rate of revision surgery, delay in bone healing, rate of pseudoarthrosis, and ankle pain will be done between the 2 groups during a postoperative period of 6 months. A cost-utility analysis will also be realized. In a subgroup of 40 patients, additional transcutaneous oxygen pressure measurements will be performed to compare the evolution of tissue oxygenation between the 2 groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Ankle Fractures

Outcomes

Primary Outcomes

Cutaneous and infectious complications

Post-surgery ankle complications including skin damage (ecchymosis, phlyctena), necrosis, superficial and deep infection and scar disunion

Time frame: 6 months

Secondary Outcomes

Observer Scar Assessment Scale (OSAS questionnaire)

The OSAS grid is used to evaluate the tolerance and scar quality obtained by the operator. It is based on an evaluation of the healing process thanks to 7 questions whose answers are rated according to an increasing scale from 1 to 10 (1 corresponding to the best result and 10 the worst). The result will lead to a score of 7 to 70 points

Time frame: 3 weeks after surgery

Observer Scar Assessment Scale (OSAS questionnaire)

Time frame: 6 weeks after surgery

Observer Scar Assessment Scale (OSAS questionnaire)

Time frame: 12 weeks after surgery

Revision surgery

Time frame: 6 months after surgery

Pseudoarthrosis Complication

Presence of delayed healing on radiograph at S24

Time frame: 24 weeks after surgery

Visual Analogue Scale (VAS) to evaluate ankle pain