Efficacy of a Bioresorbable Matrix in Healing Complex Chronic Wounds

An Open-Label Prospective Pilot Study

Sarah W. Manning, MD; David A. Humphrey, MD; William R. Shillinglaw, DO; Eric Crawford; Gaurav Pranami, PhD; Ankit Agarwal, PhD; Michael J. Schurr, MD

Disclosures

Wounds. 2020;32(11):309-318. 

In This Article

Results

Baseline Characteristics

A total of 32 patients who underwent treatment at the wound care center met the inclusion criteria listed in Table 1 and provided written consent to participate in the clinical study. One patient had 3 diabetic foot ulcers (DFUs), and another patient had 2 venous stasis ulcers; thus, a total of 35 wounds were included in the study. At baseline, all wounds were nonhealing (ie, stagnant or deteriorating) and showed signs of clinical infection (ie, pain, erythema, edema, warmth, malodor, purulent exudate, discoloration of granulation tissue, or friable granulation tissue).[24,25] Patients who did not respond to prior protocols of care, including systemic antibiotics or topical antimicrobial agents, were suspected to have persistent microbial colonization. The patients' age, wound types, and duration for which their wounds were nonhealing prior to inclusion in the study are shown in Table 2. The median age of patients enrolled in the study was 62 years (range, 22–95 years). Prior to the study, all 35 wounds had been nonhealing for a median of 39 weeks (range, 3–137 weeks). Venous stasis ulcers and DFUs had been nonhealing the longest with a median of 37 and 52 weeks, respectively. The average wound surface area at the beginning of the study was 6.7 cm2 (range, 0.1 cm2–33 cm2); the median wound surface area was 2.1 cm2. All patients had undergone multiple wound care treatment plans with various antibiotics and topical antimicrobials, including wound dressings containing iodine, betadine, and silver (Figure 2). Among 35 chronic wounds included in the study, venous stasis ulcers comprised the majority (54%) of wounds (19/35) followed by DFUs (23%; 8/35) (Figure 2).

Figure 2.

(A) Various antimicrobial treatments administered to the patients prior to starting the treatment plan with the matrix; and (B) the number of different types of wounds included in the study (N=35).

Outcomes: Primary Endpoint (3-week Assessment)

Three venous stasis ulcers were excluded from the analysis due to incomplete data sets and no follow-up visit after the first application of the matrix. After 3 weeks of treatment with the matrix, 72% (22/32) of the wounds included in the analysis had an average wound area reduction of 66% from baseline. Of the 16 venous stasis ulcers, 11 improved by an average closure rate of 60%, and 6 of 8 DFUs improved by an average wound area reduction of 79% (Table 3). At the 3-week assessment, the burn wound and postoperative wounds had average wound area reduction of 38% and 58%, respectively.

Outcomes: Secondary Endpoint (12-week Assessment)

After the primary 3-week assessment, patients continued to receive wound treatment with the matrix at least once weekly for up to 12 weeks until complete wound closure or until patients were lost to follow-up. A total of 26 wounds were treated with the matrix beyond the 3-week period. Over 12 weeks, 91% of the wounds (29/32) included in the analysis either healed completely (ie, fully reepithelialized) or documented significant improvement in healing with an average wound area reduction of 73% (Figure 3). Venous stasis ulcers and DFUs achieved an average wound area reduction greater than 75%, with visual signs of healthy granulation tissue formation and reepithelialization. There were 12 wounds with greater than a 90% wound area reduction. The burn wound was completely closed in 9.5 weeks. The 3 venous stasis ulcers, each of which was exudating, continued to increase in size and were removed from the evaluation after 4 weeks of weekly treatment with the matrix.

Figure 3.

(A) Duration of the treatment with the matrix for a given number of wounds; and (B) percent of wound area reduction achieved for each of the 32 wounds included in the study analysis during 12 weeks of treatment with the matrix.

Patient Experience

From a qualitative perspective, the application of the matrix in protocols of care for chronic wounds was well tolerated by the patients in the study. No patient reported discomfort from the application of the matrix and associated dressing changes. There were no matrix-related AEs reported during the duration of this study.

Representative Cases

Case 1: Venous Stasis Ulcer: A 58-year-old female presented with a nonhealing venous stasis ulcer. The wound had been stalled for 52 weeks at baseline. In prior treatment plans, the patient had received antibiotics, and the wound had been treated with bacitracin, Dakin's solution, or hydrogen peroxide in conjunction with compression therapy but showed no improvement. The wound then was treated weekly with the matrix and compression therapy. The initial size of the wound at the start of treatment with the matrix was 4.6 cm2. After 3 weeks of treatment with the matrix, the wound reduced in size to 2.3 cm2 (% wound area reduction = 51%). Additional weekly treatments with the matrix resulted in steady closure, with complete closure by the 12-week evaluation (Figure 4). In this case, the matrix paired with compression therapy was associated with a positive outcome.

Figure 4.

Case 1: a 58-year-old female presented with a nonhealing venous stasis ulcer stalled for 52 weeks. (A) Ulcer at the baseline; (B) ulcer was completely closed after 12 weeks (85 days) of once-weekly application of the matrix in conjunction with compression therapy; and (C) progression of wound closure with time—each data point represents a clinic visit when the matrix was reapplied.

Case 2: Venous Stasis Ulcer: A 72-year-old male presented with a nonhealing venous stasis ulcer. The wound had been stalled for 8 weeks at baseline. In prior treatment plans, the patient had received antibiotics, and the wound had been treated with an iodine-based antimicrobial absorbent pad or a silver foam in conjunction with compression therapy but showed no improvement. The wound then was treated with the matrix at weekly evaluation and compression therapy. The initial size of the wound at the start of treatment with the matrix was 5.3 cm2. After 3 weeks of treatment with the matrix, the wound reduced in size to 2.7 cm2 (% wound area reduction = 49%). Additional weekly treatments with the matrix paired with compression therapy resulted in steady closure to 0.1 cm2 (% wound area reduction = 99%) documented by the 10-week evaluation (Figure 5).

Figure 5.

Case 2: a 72-year-old male presented with a nonhealing venous stasis ulcer stalled for 8 weeks. (A) Ulcer at baseline; (B) ulcer was completely closed after 8 weeks (72 days) of once-weekly application of the matrix in conjunction with compression therapy; and (C) progression of wound closure with time—each data point represents a clinic visit when the matrix was reapplied.

Case 3: DFU. A 68-year-old male presented with a nonhealing DFU. The wound had been stalled for 31 weeks at baseline. In prior treatment plans, the patient had received gentamycin and treated with topical antimicrobials along with surgical debridement but showed no improvement. The wound then was treated with the matrix 2 to 3 times per week. The initial size of the wound was 10.6 cm2. After 4 weeks, the wound had reduced in size to 2.4 cm2 (% wound area reduction = 77%) (Figure 6). The patient did not return for subsequent follow-up.

Figure 6.

Case 3: a 68-year-old male with a nonhealing diabetic foot ulcer stalled for 31 weeks. (A) Ulcer at baseline; (B) ulcer was 77% closed after 4 weeks (26 days) of 2 to 3 weekly applications of the matrix; and (C) progression of wound closure with time—each data point represents a clinic visit when the matrix was reapplied.

Case 4: Burn Wound. A 43-year-old female presented with a nonhealing full-thickness burn wound; the patient had no comorbidities. The wound had been stalled for 5 weeks at baseline and suspected of infection. In prior treatment plans, the patient had received antibiotics, and the wound had been treated with silver sulfadiazine cream, an iodine-based absorbent pad, and a silver-based foam dressing but showed no improvement. The wound then was treated with weekly applications of the matrix and covered with gauze dressings. The wound did not require debridement during weekly evaluations, and no oral or topical antibiotics were administered. The initial size of the wound at the start of treatment with the matrix was 24.1 cm2. Three weeks after weekly treatment with the matrix, the wound reduced in size to 15 cm2 (% wound area reduction = 38%). Additional weekly treatments with the matrix resulted in steady closure of the previously stalled wound. Complete closure was achieved by the 12-week evaluation (Figure 7).

Figure 7.

Case 4: a 43-year-old female with a full-thickness burn wound stalled for 5 weeks. (A) Burn wound at baseline; (B) wound was completely closed after 12 weeks (85 days) of once-weekly application of the matrix; and (C) progression of wound closure with time—each data point represents a clinic visit when the matrix was reapplied.

Case 5: Postoperative Pilonidal Cyst. A 22-year-old female presented with a nonhealing postoperative pilonidal cyst surgical site infection. The wound had been stalled for 4 weeks at baseline. In prior treatment plans, the wound had been treated with Dakin's solution, followed by negative pressure wound therapy but showed no improvement. The wound then was treated with the matrix 2 to 3 times per week along with concurrent application of negative pressure wound therapy. The initial size of the wound was 33.3 cm2. After 6 weeks of regular treatment with the matrix, the wound had reduced in size to 0.6 cm2 (% wound area reduction = 98%) (Figure 8).

Figure 8.

Case 5: a 22-year-old female with a postop pilonidal cyst stalled for 4 weeks. (A) Wound at baseline; (B) wound was 98% closed after 6 weeks (43 days) of 2 to 3 weekly applications of the matrix; and (C) progression of wound closure with time—each data point represents a clinic visit when the matrix was reapplied.

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