Cutaneous Microcirculation After Remote Ischemic Preconditioning

NCT02417805 | Completed

• 1 other identifier: 14-266-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in microcirculation (composite measure)

  * capillary blood flow \[arbitrary units AU\] * capillary blood velocity \[AU\] * tissue oxygen saturation \[%\] * relative postcapillary venous filling pressure \[AU\]

  Baseline and 1 minute post-dose

Secondary Outcomes (1)

• Change in microcirculation (areolar measure)

  Baseline, while and 1 minute post-dose

Study Arms (4)

Second-Degree Burn

EXPERIMENTAL

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)

Procedure: Intervention: Remote Ischemic Preconditioning

Skin Excision (for Skin Graft)

EXPERIMENTAL

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)

Procedure: Intervention: Remote Ischemic Preconditioning

Chronic Wound

EXPERIMENTAL

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)

Procedure: Intervention: Remote Ischemic Preconditioning

Intact Skin

ACTIVE COMPARATOR

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)

Procedure: Intervention: Remote Ischemic Preconditioning

Interventions

Intervention: Remote Ischemic Preconditioning 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; Intact Skin; Second-Degree Burn; Skin Excision (for Skin Graft)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Tobias Kisch, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 16, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

DE (1)