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

Lahey Health

Status: Completed

Conditions: Wound Surgical; Wound Heal

Treatments: Procedure: Debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT03880331

20193001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Aggressive Debridement

Active Comparator group

Description:

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.

Treatment:

Procedure: Debridement

Minimal Debridement

Active Comparator group

Description:

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.

Treatment:

Procedure: Debridement