Postoperative Hyperbaric Oxygen Treatments to Reduce Complications in Diabetic Patients Undergoing Vascular Surgery

NCT01002209 | Withdrawn Phase 2

• 1 other identifier: HODIVA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to evaluate if hyperbaric oxygen treatment (HBO) given postoperatively is effective in reducing healing time and wound complications after lower extremity bypass surgery in patients with diabetes. Hypothesis: Postoperative HBO treatment is effective in reducing complications in patients with diabetes undergoing peripheral vascular surgery

Conditions

Diabetes; Peripheral Arterial Disease; Arterial Occlusive Disease

Keywords

Diabetes; Vascular Surgery; Hyperbaric oxygen; Surgical complications; Wound complication; Randomized; Controlled

Outcome Measures

Primary Outcomes (1)

• Time to complete healing of operative wounds

  7-365 days

Secondary Outcomes (8)

• Number of wound infections at 7 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.

  7 days (plus minus 3 days)

• Number of wound infections at 30 days assessed by ASEPSIS score. A score over 20 will be considered as a wound infection.

  30 days (plus minus 3 days)

• The severity of wound infection defined as by ASEPSIS score: 0-10= satisfactory healing 11-20= disturbed healing 21-30= minor wound infection 31-40= moderate wound infection >40= severe wound infection.

  highest score up to 30 days (plus minus 3 days)

• A combination of any wound infection and/or unhealed wounds at 30 days (combined endpoint).

  30 days (plus minus 3 days)

• SF-36 score

  7, 14, 28, 365 days (plus minus 3 days)

Study Arms (2)

Sham Hyperbaric Oxygen Treatment

SHAM COMPARATOR

Procedure: Sham HBO

Hyperbaric oxygen treatment (HBO)

EXPERIMENTAL

Procedure: Hyperbaric Oxygen treatment (HBO)

Interventions

Hyperbaric Oxygen treatment (HBO) PROCEDURE

HBO treatment will be given in a monoplace chamber and will start on first postoperative day (study day 1). The HBO group will be treated with 100% oxygen at 2.5 bar for 100 min with two 10 min airbrakes (without mask). HBO treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO/placebo treatment and who have a clearly uncomplicated postoperative course will terminate HBO/placebo treatment on the day of discharge from hospital.

Hyperbaric oxygen treatment (HBO)

Sham HBO PROCEDURE

HBO sham treatment will start on first postoperative day (study day 1). HBO sham treatment will be given twice daily first three days (study day 1-3) and then once daily for up to three days (study day 4-6). The total number of treatments will be at least 6 and at most 9 treatments. Patients who have received at least three days HBO sham treatments and who have a clearly uncomplicated postoperative course will terminate HBO sham treatment on the day of discharge from hospital. For patient blinding purposes, the sham group will breathe air and will be given a brief compression to 1.5 bar at the beginning of each treatment after which the chamber is slowly decompressed to 1.1, 1.2 , 1.3, or 1.4 bar corresponding to 0.23 ,0.25, 0.27, and 0.29 bar inspired oxygen. Two 10 min "airbrakes" will also be included.

Sham Hyperbaric Oxygen Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained
• Scheduled for lower extremity open vascular surgery
• Diabetes treated with insulin or oral antidiabetic medicine
• Age ≥ 18 years

You may not qualify if:

• Contraindications to HBO therapy
• Patients already in HBO treatment
• Vascular reoperation
• Creatinine \> 250 mmol/L
• NYHA class IV heart failure or severe cardiopulmonary disease with desaturation judged to be incompatible with safe HBO/ placebo therapy in a monoplace chamber
• Clinically significant chronic obstructive pulmonary disease.
• Acute sepsis.
• Malignancy or other serious medical condition where it is likely that the patient will significantly deteriorate or not survive within the two years of follow up.
• Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices.
• Mental condition making the subject unable to understand the concepts and risk of the study

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Arterial Disease; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Kerstin Brismar, Professor

  Karolinska Institutet

  STUDY DIRECTOR

• Jonas Malmstedt, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Folke G Lind, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Sergiu Catrina, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Joy Roy, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Nils Pettersson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Bengt M Eriksson, MD

  Hyperbaric Medicine, Karolinska Univ Hosp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

SE (1)