N/A N=22 Randomized Single-blind Treatment

Efficacy of Laser Debridement on Pain and Bacterial Load in Chronic Wounds

Wound Open · Chronic Venous Hypertension (Idiopathic) With Ulcer · Diabetic Foot Ulcer

Bottom Line

View on ClinicalTrials.gov: NCT03182582 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Pain With Debridement — 3.0; 4.8 units on a scale — p=0.003

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement (Device); Scalpel/Curette Debridement (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain With Debridement	3.0; 4.8	0.003 sig
PRIMARY Bacterial Load Pre- and Post-Laser Debridement	0; 2; 6; 11; 16; 9	—
PRIMARY Bacterial Load Pre- and Post-Sharp Debridement	0; 5; 12; 10; 10; 7	—
SECONDARY Patient Preference	9; 6; 2	—
SECONDARY Percent Change in Wound Size- Immediately Post-debridement	40.2; 63.4	—
SECONDARY Percent Change in Wound Size - 1 Week Post-debridement	-20.8; -36.7	—

Summary

Bacterial load is frequently associated with impaired healing of chronic wounds. As well, sharp debridement is often associated with pain, causing patient distress, and thereby occasionally contributing to inadequacy of debridement, leading to a delay in wound healing. The purpose of this study is to assess the efficacy of the Sciton Laser in reducing bacterial load and patient distress in patients with chronic wounds, in efforts to expedite the wound healing process.

Eligibility Criteria

Inclusion Criteria

Aged eighteen years or older
Having a chronic wound (as defined by lack of at least 50% reduction in wound surface area over a period of four weeks)
No clinical evidence of active wound bed infection
No exposure of any vital structure (i.e., tendon, bone, vessel)
Has signed the informed consent form prior to any study protocol related procedure
Willing and able to adhere to protocol requirements

Exclusion Criteria

Any unstable medical condition that would cause the study treatment to be detrimental to the subject, as judged by the Principle Investigator
Documented medical history of significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), metabolic, neurological, hepatic or nephrologic disease would impede the subject's participation, as judged by the Principle Investigator
Documented medical history of immunosuppression, immune deficiency disorder, or currently using immunosuppressive medications
Having clinical presentation of active osteomyelitis
Pregnancy or lactation
Participation in another clinical study involving ulcers within thirty days prior to enrollment

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Data sourced from ClinicalTrials.gov (NCT03182582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.