Clinical trial NCT04677166: Coupling Negative Pressure Wound Therapy With Instillation
Official title: Coupling Negative Pressure Wound Therapy With Instillation for Optimal Graft Take: Randomized Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound
Ulcer
Burns
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Acelity
name: KCI USA, Inc
First posted: 2020-12-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either the treatment group (negative pressure wound therapy coupled with instillation) or the control group (standard negative pressure wound therapy). Both groups will receive four days of intervention and outcomes will be measured at day four of negative pressure wound therapy and at thirty days post-operatively.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare standard negative pressure wound therapy with negative pressure wound therapy coupled with instillation for optimal skin graft take. Either the V.A.C ULTA NPWT or V.A.C. VeraFlo Therapy systems with normal saline will be applied intra-operatively to split-thickness skin grafts of upper and lower extremity wounds and kept in place for a duration of four days. Following completion of four days, the skin graft with be assessed for percentage of take/adherence and will be covered with simple gauze dressings as needed.

Detailed description: Past studies have investigated the use of NPWT for post-operative skin graft treatment and shown superior outcomes regarding graft take and need for repeat grafting when compared with standard gauze dressing. However, to date, no study has compared standard NPWT to NPWT coupled with instillation for post-operative treatment of extremity skin grafts. This study is designed as a randomized, controlled pilot study to compare treatment standard NPWT with NPWT coupled with instillation on skin graft take.

Patients will be selected based on inclusion criteria and randomized to either the treatment (NPWT coupled with instillation) or the control group (standard NPWT). Depending on the group to which they are randomized to, patients will have standard NPWT or NPWT coupled with instillation applied intra-operatively after application of split thickness skin graft for treatment of extremity wound.

Patients randomized to control group will receive V.A.C Ulta NPWT at 125mmHg continuous pressure for duration of four days.

Patients randomized to treatment group will receive V.A.C VeraFlo therapy. Protocol will consist of the following:

* Instillation solution: normal saline
* Dwell/soak time: 30 seconds
* Cycle Time: 4 hours
* Pressure: 125mmHg

The devices will be kept in place for four days, at which point, the wound vacs will be removed and the percentage of skin graft take will be evaluated with use of photometric analysis. The skin grafts will be subsequently dressed with gauze as appropriate. Patients will be followed up in clinic to assess outcome of skin graft take.

Eligibility criteria: Inclusion Criteria:

* Patients who have been offered split-thickness skin graft for treatment of an extremity wound.

Exclusion Criteria:

* Abnormal healing (diagnosed with connective tissue disorder)
* Uncontrolled diabetes mellitus (HgbA1c \>9)

Primary outcomes:
measure: Percentage of Skin Graft Take at Four Days Post-Operative
timeFrame: 4 days from intervention
Secondary outcomes:
measure: Percentage of Skin Graft Take at Thirty Days Post-Operative
timeFrame: 30 days from intervention
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda
name: Subhas W Gupta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yin Y, Zhang R, Li S, Guo J, Hou Z, Zhang Y. Negative-pressure therapy versus conventional therapy on split-thickness skin graft: A systematic review and meta-analysis. Int J Surg. 2018 Feb;50:43-48. doi: 10.1016/j.ijsu.2017.12.020. Epub 2017 Dec 29.
citation: Nguyen TQ, Franczyk M, Lee JC, Greives MR, O'Connor A, Gottlieb LJ. Prospective randomized controlled trial comparing two methods of securing skin grafts using negative pressure wound therapy: vacuum-assisted closure and gauze suction. J Burn Care Res. 2015 Mar-Apr;36(2):324-8. doi: 10.1097/BCR.0000000000000089.