Cutaneous Microcirculation After Remote Ischemic Preconditioning

NCT ID: NCT02417805

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2023-02-28

Brief Summary

In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that remote ischemic preconditioning (RIPC) can accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on second-degree burns, superficial and chronic wounds in a human in-vivo setting for the first time.

Conditions

Burn Injury; Acute Wound; Chronic Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Second-Degree Burn

Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Group Type: EXPERIMENTAL

Intervention: Remote Ischemic Preconditioning

Intervention Type: PROCEDURE

Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.

Skin Excision (for Skin Graft)

Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Group Type: EXPERIMENTAL

Intervention: Remote Ischemic Preconditioning

Intervention Type: PROCEDURE

Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.

Chronic Wound

Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Group Type: EXPERIMENTAL

Intervention: Remote Ischemic Preconditioning

Intervention Type: PROCEDURE

Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.

Intact Skin

Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident.

Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Group Type: ACTIVE_COMPARATOR

Intervention: Remote Ischemic Preconditioning

Intervention Type: PROCEDURE

Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.

Interventions

Intervention: Remote Ischemic Preconditioning

Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body.

Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA.

Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA.

Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. No soft tissue injury must be evident.

Exclusion Criteria

• below 18 years of age
• wounds requiring artificial respiration, since consent for the study participation is unobtainable

• peripheral arterial occlusive disease
• vasculitis
• diabetes mellitus
• chronic kidney or liver disease
• cardiac dysfunction
• arterial hypo- or hypertension

• ongoing immunosuppressive or chemotherapy treatment
• drug abuse
• systemic skin diseases
• systemic and local cortisone therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Tobias Kisch

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Kisch, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

14-266-2

Identifier Type: -

Identifier Source: org_study_id