Randomized, Investigator-blinded Study of Compression in Wound Healing With and Without Fractional Ablative CO2 Laser After Excisions on the Lower Extremity (CHIME+)

Summary

The purpose of this study is to determine the efficacy and safety of compression bandaging with fractional ablative carbon dioxide laser (FACL) compared to compression and standard dressings alone for healing of post-operative wounds of the leg. This is a randomized, SMART design, clinical trial. Approximately 80 participants will be randomized to initially receive compression bandages or standard wound dressings after surgery on the lower leg. After 4 weeks, the group assigned to compression bandages will be further randomized to either continue with the compression bandages only or continue with the compression bandages and also receive (FACL). The study is designed as an 6-month study. This study was a pilot study designed to determine feasibility of these procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

Yes

Interventions

• Other
  Compression bandages

  Class I (20-30 mmHg) compression bandages or stocking

• Other
  Standard wound dressings

  Wound dressings alone consisting of gauze and skin tape to cover the wound

• Device
  Fractional ablative carbon dioxide laser

  Participant will have laser applied to their wound bed.

Location