Placental Membranes for Management of Refractory Cutaneous Sinus Tracts of Surgical Origin: A Pilot Study

Abstract

Despite advances in surgical technique, postoperative complications may lead to refractory cutaneous sinus tracts or tunnels. Negative pressure wound therapy is difficult to apply in longer tracts with a narrow diameter opening and conservative treatment failures ultimately necessitate surgical revisions. The aim of this pilot study was a clinical utility assessment of two different commercial placental membrane products for refractory cutaneous sinus tracts of surgical origin. Patients were treated with viable cryopreserved placental membrane (vCPM, n = 6) or devitalized dehydrated amnion/chorion membrane (dHACM, n = 6). The primary outcome measurement was the proportion of complete sinus tract depth resolution without exudate. Secondary endpoints included 4-week percent reduction in sinus tract probing depth and peri-tract wound surface area, days and number of grafts to resolution, number of wound-related infections, and 1-year recurrence rate for closed sinus tracts. All vCPM patients demonstrated complete sinus tract resolution compared to zero closures in the dHACM group (p = 0.00216). The vCPM group achieved greater percent reduction in probing depth (73.3 ± 21.9 versus −4.4 ± 91.3) and surrounding wound surface area (34.8 ± 86.8 versus −279.3 ± 454.9) at 4 weeks than dHACM. The use of viable intact cryopreserved placental membrane has demonstrated positive clinical outcomes for the treatment for refractory exudative sinus tracts and may be an alternative to repeat surgical intervention.

Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells

“…Clinical outcomes of vCPM have been reported in multiple studies for wounds of various etiologies and locations. [12][13][14][15][16][17][18][19][20] In the present study using vLPM adjunct to SOC, we demonstrated similar closure rates to those rates previously shown in clinical studies with the cryopreserved formulation (Fig. 2).…”

“…[8][9][10][11] High closure rates for difficult-to-treat wounds of different etiologies and locations have been demonstrated in multiple vCPM clinical studies. [12][13][14][15][16][17][18][19][20] Two prospective studies, one utilizing amnionderived vCPM and one utilizing chorion-derived vCPM, demonstrated a 62% and 59.3% closure rate for chronic diabetic foot ulcers (DFUs) and chronic complex DFUs, respectively. 12,14 Results of these DFU prospective clinical trials are mirrored by reported DFU closure rates in real-world patients.…”

“…16 Multiple vCPM case series' in different patient populations, such as peripheral arterial disease (PAD) smokers, patients with surgical tract wounds, or with exposed hardware, have reported high and durable closure rates. [18][19][20] In two retrospective studies, various types of wounds managed with vCPM plus SOC showed closure rates of 76.1% and 63.0%, respectively. 13,15 In a prospective, single-arm study, 53.0% of patients achieved complete wound closure with vCPM plus SOC in the treatment of chronic venous leg ulcers (VLUs) that had previously failed 12 weeks of SOC.…”

Properties of viable lyopreserved amnion are equivalent to viable cryopreserved amnion with the convenience of ambient storage

“…Previous studies on devitalized VCAM have demonstrated that viable cells are required for the tissue to respond in vitro in a wound-mimicking environment [ 18 , 45 , 46 ]. Clinical studies have demonstrated that VCAM results in a higher rate of wound closure in comparison to devitalized amnion-chorion for intractable large or sinus track wounds [ 26 , 27 ].…”

“…Other VCAM retrospective and prospective clinical studies reported positive clinical outcomes in patients with acute and chronic wounds of various etiologies, and in a variety of surgical procedures [ 22 – 25 ]. Comparative effectiveness studies of VCAM versus a devitalized dehydrated amnion chorion product showed that the use of VCAM resulted in higher wound closure rate of larger, more difficult to treat wounds [ 26 , 27 ]. Clinical results are consistent with results from in vitro studies providing further support for preserving all components of native placental tissues.…”