Efficacy of the Application of a Purified Native Collagen With Embedded Antimicrobial Barrier Followed by a Placental Allograft on a Diverse Group of Nonhealing Wounds of Various Etiologies: A Case Series

George J. Koullias, MD, PhD

Disclosures

Wounds. 2021;33(1):20-27. 

In This Article

Results

Patients received an average of 5.9 applications of PCMP, followed by an average of 3.2 applications of dACM or HSAM. Combined, an average of 9 applications of PCMP and dACM or HSAM placental allograft were done. Sixteen wounds were included in the study; however, 1 patient was excluded from the assessment of healing rates due to death at week 12 resulting from complications of cancer treatment. Of the remaining 15 wounds, 13 (86.67%) closed at or before week 12, with the remaining 2 wounds achieving complete wound closure (CWC) by week 17. For the patient who died, measurements taken at the patient's last visit to the wound care center showed a 73% reduction from baseline during treatment. A summary of the clinical course for all patients is shown in Table 2.

A subgroup analysis of the larger wounds (> 25 cm2) was conducted in addition to analysis of all wounds regardless of size. Of the 16 wounds, 6 (37.5%) were present for 8.5 weeks and ranged in size from 31 cm2 to 78 cm2. The mean baseline area (SD) and median baseline area of these larger wounds were 43.5 cm2 (15.99) and 42 cm2, respectively (Table 1). A large neck wound in a patient who died from complications related to cancer treatment at 12 weeks was included in these baseline area computations; however, this wound was excluded from calculating mean and median time to closure. Only the subset of large wounds were treated with an average of 7 PCMP applications followed by an average of 3.5 placental allograft applications. Using PCMP and placental allografts in combination resulted in an average of 10.5 total applications per patient. Following treatments (ie, first treatment with debridement followed by application of PCMP and placental allografts), the mean time (SD) and median time to CWC were 11.6 weeks (4.45) and 11.3 weeks, respectively. Of the 5 larger wounds, 3 (60%) closed before 12 weeks.

Case 1: Skin Squamous Carcinoma Excision

An 80-year-old female with a history of hypertension, hyperlipidemia, and multiple skin squamous carcinoma excisions presented with a squamous carcinoma repeat excision wound of 1 month's duration measuring 35 cm2, with a cellulitic, infected, and necrotic dehisced flap at the excision site on the right calf. Wound biopsies were negative for malignancy. Arterial examination was normal, and duplex ultrasonography to assess for venous insufficiency showed no serious form of venous reflux. Serial wound debridements followed by once-weekly treatment with PCMP application were performed. This treatment continued for 6 weeks. When the wound bed demonstrated an evident granular base, no drainage, and reduced tenderness, PCMP application was stopped and dACM application was started. This new treatment was applied once-weekly for 5 weeks. Complete wound closure was achieved by week 11 (Figure 1).

Figure 1.

Wound healing progression of a squamous carcinoma wound of 3–6 months' duration, measuring 35 cm2, on the right lower leg of an 80-year-old female with a history of hypertension and cancer: (A) week 1, (B) week 2, (C) week 6, (D) week 9, and (E) week 11. (A) Before and (B–D) after 6 once-weekly applications of purified collagen matrix with embedded polyhexamethylene biguanide followed by 5 subsequent once-weekly applications of dehydrated amnion/chorion membrane. (E) The wound healed completely by week 11.

Case 2: Advanced Squamous Cell Carcinoma

A 64-year-old female with a history of chronic smoking (25 years) presented with a progressively enlarging, foul-smelling, necrotic, and draining exophytic left neck mass of 2 years' duration. She was immediately referred to an oncologist, who diagnosed the mass as a locally advanced squamous cell carcinoma with deep tissue penetration and invasion of the left carotid sheath. The patient refused radiation therapy but consented to and was started on a triple chemotherapy regimen. After initiation of chemotherapy, she was sent back to the wound care center for wound, odor, and drainage management. The wound was managed with active carbon dressings for odor control, highly absorbent foam for drainage control, and once-weekly serial debridement and PCMP applications for biofilm management and reduction of wound surface area. Because of the proximity of the wound bed to the lateral pharynx and esophagus as well as to the left common carotid artery, every effort was made to elevate the wound bed and heal the wound expeditiously, also taking into account the extensive cytotoxic effects of chemotherapy. Wound biopsies performed during chemotherapy were negative for malignancy. Upon completion of initial management of necrotic debris and odor, the baseline wound area measured 78 cm2. The wound area decreased to 42 cm2 after removal of necrotic tissue, at which time PCMP applications were started. The wound was managed with 7 applications of PCMP and 1 of dACM. The patient tolerated chemotherapy well; however, at week 11 she acquired pneumonia, and at week 12 she died. By the time of the patient's death, the wound area had reduced by 73%, and the distance of the wound bed from the wall of the left common carotid artery had increased by almost 1 cm (Figure 2).

Figure 2.

Wound healing progression of a squamous carcinoma wound of 2.5 months' duration, measuring 42 cm2, in the neck of a 64-year-old female with a history of chronic smoking (25 years): (A) week 1, (B) week 5, (C) week 6, and (D) week 11. (A) Before and (B, C) during 7 applications of purified collagen matrix with embedded polyhexamethylene biguanide and 1 subsequent application of dACM. (D) The area of the wound reduced by 73% by week 11 (1 week before the patient died).

Case 3: Ischemic Wound (Medial Mid-calf)

A 75-year-old female with a history of heavy smoking (28 years), coronary artery disease, previous non-ST-elevation myocardial infarction, aortic stenosis, congestive heart failure, poorly managed type 2 diabetes, hyperlipidemia, hypertension, rheumatic fever (in adolescence), previous aortobifemoral bypass graft for abdominal aortic occlusive disease, and short distance claudication in the right leg presented with fever, chills, and an ischemic, infected, draining, malodorous wound measuring 42 cm2 at the right medial mid-calf. Antibiotic therapy was initiated. Arterial workup showed extensive arterial occlusive disease, with occlusion in the right common femoral artery and a 20-cm occlusion in the right superficial femoral artery in addition to severe infrapopliteal disease with occluded right peroneal and posterior tibial arteries. Venous mapping showed the saphenous veins to be inadequate for use as bypass conduits. Because of the severely infected, ischemic wound and also because of the occluded right common femoral artery and status post remote Dacron (INVISTA) aortobifemoral bypass, the patient was treated with right aortobifemoral–to-distal superficial femoral artery bypass with human cadaveric cryopreserved saphenous vein. Following these procedures and treatment, the patient underwent serial weekly wound debridement followed by 5 once-weekly applications of PCMP and then 3 once-weekly applications of HSAM. Complete wound healing was achieved by week 9 (Figure 3).

Figure 3.

Wound healing progression of (A) an ischemic infected wound of 2 months' duration, measuring 42 cm2, in the lower leg of a 73-year-old female with a history of chronic smoking, hypertension, arterial artery disease, heart failure, and poorly managed type 2 diabetes. The patient received (B [week 2] and C [week 5]) 5 once-weekly applications of purified collagen matrix with embedded polyhexamethylene biguanide, followed by 3 once-weekly applications of hypothermically stored amniotic membrane. (D) Complete wound healing was achieved by week 8.

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