Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lahey Clinic
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Time to healing
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Blinded investigator will assess photographs of completely healed wounds
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Dermatology patients at Lahey Clinic:
- •who have undergone Mohs surgery or excision
- •who are older than 18 years
- •who are able to give consent
- •who had postoperative defects allowed to heal by secondary intention on the a) head and neck, b) trunk and upper extremities, c) lower extremities
- •who are willing and able to return to clinic in Peabody, MA, for all wound care visits
Exclusion Criteria
- •Unable to consent (due to language barrier or mental status)
- •Unable to perform daily wound care
- •Unwilling or unable to return for follow-up
- •Have baseline venous stasis or pitting edema of the affected limb
- •Wear compression stockings or require use of a compressive bandage (such as an Unna Boot) at baseline.
Outcomes
Primary Outcomes
Time to healing
Time Frame: 0-16 weeks
Time to complete healing as determined by one of the study investigators
Secondary Outcomes
- Cosmetic Appearance(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)
- Number of required debridements(0-16 weeks)
- Patient satisfaction with scar: Patient Scar Assessment Questionnaire (PSAQ)(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.)
- Number of treatment failures(Through study completion, an average of 6-8 weeks)
- Complications(0-16 weeks)
Investigators
Jeffrey Tiger
Principal Investigator
Lahey Clinic