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

Not Applicable

Completed

• Conditions: Wound Heal; Wound Surgical
• Interventions: Procedure: Debridement

• Registration Number: NCT03880331
• Lead Sponsor: Lahey Clinic

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 Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-19
• Study Start: 2019-12-03
• Primary Completion: 2020-07-01
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aggressive Debridement	Debridement	Aggressive and frequent debridement of fibrin and crust from the wound base down to pinpoint bleeding, both by the patient as part of daily wound care at home, and also by the clinician (either physician or experienced dermatologic surgery nurse) during follow-up visits. Silver nitrate will be used to treat excessive granulation tissue only if the granulation tissue is higher than the level of surrounding skin. Patients will return weekly until healed. Patients will be provided with detailed instructions and guidelines to help determine whether healing has taken place.
Minimal Debridement	Debridement	No debridement of fibrin by the patient or the clinician. Exceptions include debridement of dried crust or eschar. Silver nitrate will be used to treat excessive granulation tissue only if the granulation tissue is higher than the level of surrounding skin. Patients will return every two weeks until healed. In between visits at weekly intervals, the patient will be contacted by phone to determine if healing has occurred in between clinic visits11. Patients will be provided with detailed instructions and guidelines to help determine whether healing has taken place.

Primary Outcome Measures

Name	Time	Method
Time to healing	0-16 weeks	Time to complete healing as determined by one of the study investigators

Secondary Outcome Measures

Name	Time	Method
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	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.
Number of required debridements	0-16 weeks	Number of required debridements over the course of healing
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.	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.
Number of treatment failures	Through study completion, an average of 6-8 weeks	Number of wounds that do not heal by 16 weeks
Complications	0-16 weeks	Including degree of pain (on a scale of 0-10), number of episodes of bleeding, number of infection, and incidence of tumor recurrence

Trial Locations

Locations (1)

Lahey Medical Center Peabody; 🇺🇸 Peabody, Massachusetts, United States