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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880331
• Other study ID #: 20193001
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wound Surgical
• Wounds and Injuries

Intervention

Procedure:
• Debridement
Aggressive vs Minimal Debridement

Locations

Country	Name	City	State
United States	Lahey Medical Center Peabody	Peabody	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. Review. — View 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. — View 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. — View Citation

Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Steed DL. Debridement. Am J Surg. 2004 May;187(5A):71S-74S. Review. — View 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. Erratum in: JAMA Dermatol. 2013 Dec;149(12):1441. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to healing	Time to complete healing as determined by one of the study investigators	0-16 weeks
Secondary	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.	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.
Secondary	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.	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
Secondary	Number of required debridements	Number of required debridements over the course of healing	0-16 weeks
Secondary	Number of treatment failures	Number of wounds that do not heal by 16 weeks	Through study completion, an average of 6-8 weeks
Secondary	Complications	Including degree of pain (on a scale of 0-10), number of episodes of bleeding, number of infection, and incidence of tumor recurrence	0-16 weeks