Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods

Lahey Clinic8 enrolled

Overview

This is a randomized controlled trial which is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.

Secondary intention is an established method of allowing post-surgical defects to heal. Previous studies have shown a positive association between the frequency of debridement and healing rates in chronic wounds. However, the effect of debridement on acute, post-surgical wounds is not well-described in the literature. This randomized controlled trial is designed to determine whether aggressive and frequent debridement of an acute post-surgical wound shortens healing time.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Wound Surgical Wound Heal

Interventions

DebridementPROCEDURE

Aggressive vs Minimal Debridement

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Dermatology patients at Lahey Clinic: 2. who have undergone Mohs surgery or excision 3. who are older than 18 years 4. who are able to give consent 5. who had postoperative defects allowed to heal by secondary intention on the a) head and neck, b) trunk and upper extremities, c) lower extremities 6. who are willing and able to return to clinic in Peabody, MA, for all wound care visits Exclusion Criteria: 1. Unable to consent (due to language barrier or mental status) 2. Unable to perform daily wound care 3. Unwilling or unable to return for follow-up 4. Have baseline venous stasis or pitting edema of the affected limb 5. Wear compression stockings or require use of a compressive bandage (such as an Unna Boot) at baseline.

Locations (1)

Lahey Medical Center Peabody

Peabody, Massachusetts, United States

Outcomes

Primary Outcomes

Time to healing

Time to complete healing as determined by one of the study investigators

Time frame: 0-16 weeks

Secondary Outcomes

Patient satisfaction with scar: Patient Scar Assessment Questionnaire (PSAQ)

As assessed by the Patient Scar Assessment Questionnaire (PSAQ), a validated questionnaire used standardly in Dermatology for assessing patient-based outcome measures of scarring. It consists of 5 subscales: appearance, symptoms consciousness, satisfaction with appearance and satisfaction with symptoms. Each subscale consists of a set of items with 4-point categorical responses, scoring 1 to 4 points (with 1 point assigned to the most favorable category and 4 assigned to the least favorable). It has been demonstrated to be a reliable and valid measure of patients' perception of scarring. See reference #12 in reference list for more information.

Time frame: 0-16 weeks. NOTE: The PSAQ will be completed by the patient once their wound is determined to be completely healed by the study investigators; usually between 6-8 weeks.

Cosmetic Appearance

As assessed by the Visual Analog Scale, a validated image-based scale, that uses photographs for evaluation in 5 dimensions (pigmentation, vascularity, acceptability, observer comfort, and contour). "Observer comfort" measures the observer's "comfort level" when viewing the wound. The benefit of using this scale for the purposes of the study is because it is a photograph-based scale which can be evaluated later by a blinded physician rather than in the clinic at the time of the visit. The observer places a mark along a continuous line that measures 10cm long, and then that is measured from left to right and a corresponding score is given corresponding to that length (between 0 and 10). The individual scores are tallied to obtain a single overall score ranging from "poor" to "excellent." See reference #13 in reference list for more information.

Time frame: 0-16 weeks. NOTE: A photograph of the the patient's final healed wound will be evaluated by a blinded investigator after the wound is determined to be completely healed by the study investigators; usually between 6-8 weeks

Data from ClinicalTrials.gov

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