Clinical trial NCT03880331: Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
Official title: Prospective Randomized Clinical Trial Comparing Outcomes of Secondary Intention Wound Care Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Surgical
Wound Heal
Keywords: Secondary intention
Wound care methods
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to healing
timeFrame: 0-16 weeks
Secondary outcomes:
measure: Patient satisfaction with scar: Patient Scar Assessment Questionnaire (PSAQ)
timeFrame: 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.
measure: Cosmetic Appearance
timeFrame: 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
measure: Number of required debridements
timeFrame: 0-16 weeks
measure: Number of treatment failures
timeFrame: Through study completion, an average of 6-8 weeks
measure: Complications
timeFrame: 0-16 weeks
Other outcomes:
Locations:
city: Peabody
country: United States
facility: Lahey Medical Center Peabody
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Jeffrey B Tiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saap LJ, Falanga V. Debridement performance index and its correlation with complete closure of diabetic foot ulcers. Wound Repair Regen. 2002 Nov-Dec;10(6):354-9. doi: 10.1046/j.1524-475x.2002.10603.x.
citation: Steed DL. Debridement. Am J Surg. 2004 May;187(5A):71S-74S. doi: 10.1016/S0002-9610(03)00307-6.
citation: Hess CT, Kirsner RS. Orchestrating wound healing: assessing and preparing the wound bed. Adv Skin Wound Care. 2003 Sep-Oct;16(5):246-57; quiz 258-9. doi: 10.1097/00129334-200309000-00015.
citation: Fonder MA, Lazarus GS, Cowan DA, Aronson-Cook B, Kohli AR, Mamelak AJ. Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. J Am Acad Dermatol. 2008 Feb;58(2):185-206. doi: 10.1016/j.jaad.2007.08.048.
citation: Alavi A, Sibbald RG, Phillips TJ, Miller OF, Margolis DJ, Marston W, Woo K, Romanelli M, Kirsner RS. What's new: Management of venous leg ulcers: Treating venous leg ulcers. J Am Acad Dermatol. 2016 Apr;74(4):643-64; quiz 665-6. doi: 10.1016/j.jaad.2015.03.059.
citation: Wilcox JR, Carter MJ, Covington S. Frequency of debridements and time to heal: a retrospective cohort study of 312 744 wounds. JAMA Dermatol. 2013 Sep;149(9):1050-8. doi: 10.1001/jamadermatol.2013.4960.
citation: Luft HS. Becoming accountable-opportunities and obstacles for ACOs. N Engl J Med. 2010 Oct 7;363(15):1389-91. doi: 10.1056/NEJMp1009380. No abstract available.
citation: Gloster HM Jr. The use of second-intention healing for partial-thickness Mohs defects involving the vermilion and/or mucosal surfaces of the lip. J Am Acad Dermatol. 2002 Dec;47(6):893-7. doi: 10.1067/mjd.2002.125065.
citation: Gohari S, Gambla C, Healey M, Spaulding G, Gordon KB, Swan J, Cook B, West DP, Lapiere JC. Evaluation of tissue-engineered skin (human skin substitute) and secondary intention healing in the treatment of full thickness wounds after Mohs micrographic or excisional surgery. Dermatol Surg. 2002 Dec;28(12):1107-14; discussion 1114. doi: 10.1046/j.1524-4725.2002.02130.x.
citation: Dodson MK, Magann EF, Meeks GR. A randomized comparison of secondary closure and secondary intention in patients with superficial wound dehiscence. Obstet Gynecol. 1992 Sep;80(3 Pt 1):321-4.
citation: Joo J, Custis T, Armstrong AW, King TH, Omlin K, Kappel ST, Eisen DB. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. JAMA Dermatol. 2015 Mar;151(3):265-70. doi: 10.1001/jamadermatol.2014.2313.
citation: Durani P, McGrouther DA, Ferguson MW. The Patient Scar Assessment Questionnaire: a reliable and valid patient-reported outcomes measure for linear scars. Plast Reconstr Surg. 2009 May;123(5):1481-1489. doi: 10.1097/PRS.0b013e3181a205de.
citation: Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.