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Advanced wound care for complicated wounds

Comparative clinical study in 266 patients - published study

Aim

  • To compare MPPT to an antibiotic and an antiseptic to determine whether MPPT, which acts by balancing the microbiome, is superior to approaches that kill the bacteria in the wound.
  • To determine the effects on early healing rates as these are predictive for time to full wound closure.

Entry criteria

  • Post-operative wounds, carbuncles, diabetic foot and venous leg ulcers or burns
  • Presence of necrosis and tissue infiltration, i.e. infection.

Comparison groups

  • SertaSil
  • Gentaxane (an absorbing powder containing the antibiotic gentamicine)
  • Ioddicerin (iodine combined with DMSO, where DMSO is used to improve tissue penetration)

Application period

  • Once daily application until achieving a clean wound, i.e. free from necrosis, pus and fibrinogenous thickenings.

Measurements

  • For subgroup of post-surgical wounds and abscesses, wound surface area at 4 time points over 10 days..
  • For all wounds, days to reach 3 key stages in the wound healing process.


Results

Patient Enrolment

266 patients with wounds requiring the intervention of a surgeon were included in the study. The wounds were primarily trophic ulcers caused by pancreatic diabetes and venous insufficiency of lower extremities, carbuncles, infected heat burns of degree III B - IV, and infiltrations of postoperative wounds.

 

Days to Wound Closure

The group receiving SertaSil demonstrated substantially faster wound closure compared to patients receiving Gentaxane or Ioddicerin.

Rates of wound closure

In a subgroup of patients with comparable wound sizes and pathology, the wound surface area was measured at 4 time points (mean ± SD) from the start of application (N=30 per group with 80% carbuncles, abscesses, and cysts and 20% infected wounds in all three groups).

Days to specific wound healing stages

Patients receiving SertaSil reached a clean wound in 3 days compared to 7 and 8 days for Gentaxane and Ioddicerin. This acceleration of the first stage of the wound healing process also reduced the time to reach the subsequent stages as seen by a faster onset of granulation and epithelialization for wounds receiving SertaSil.

Effects on wound healing stages

Days (mean ± SD) to reach three Wound Healing Stages in patients following application with SertaSil (n=88), Gentaxane (n=90), or Ioddicerin (n=88).


Hospitalisation days

Patients receiving SertaSil had 31% fewer hospitalisation days compared to Gentaxane and 39% fewer compared to Ioddicerin.

 

Conclusions

  • SertaSil reduced the time to reaching a clean wound by 60%.
  • SertaSil accelerated the early healing rates and this translated into faster wound closure.
  • SertaSil did not cause any severe adverse events, wound irritation or sensitisation.
  • An approach based on supporting the return of control of the microbiome to the immune system is highly superior to approaches that are based on the killing of bacteria in the microbiome.

 More detail open

 

 

SertaSil was compared to the topical antibiotic Gentaxane (gentamicin, L-tryptophan and zinc sulphate in a polymethylsiloxane powder) and the antiseptic Ioddicerin (0.5% iodine, 30% dimexide (dimethylsulfoxyde), and 69.5% glycerine) in a clinical study to determine if SertaSil reduced the time for the wounds to reach wound cleansing and how this affected the time for onset of granulation and epithelialization. Topical antibiotics and antiseptics such as iodine are standard treatments for infected wounds.

The study included 266 patients with wounds in which a necrotic component and tissue infiltration, caused by infections, predominated. Patients were assigned to treatment groups by sequential allocation. SertaSil, Gentaxane and Ioddicerin were applied once daily until the achieving a clean wound, i.e. free from necrosis, pus and fibrinogenous thickenings. The wounds were primarily trophic ulcers caused by pancreatic diabetes and venous insufficiency of lower extremities, carbuncles, infected heat burns of degree III B - IV, and infiltrations of postoperative wounds. Patients with advanced diabetic foot ulcers at the stage requiring amputation were excluded.

The study included a wide range of wound types and wound sizes for which reason it would not be possible to use wound surface area as a meaningful measure for all wounds. Instead, surface area was only measured in a subgroup of patients with comparable wound sizes and pathology (N=30 per group with 80% carbuncles, abscesses, and cysts and 20% infected wounds in all three groups). The wound surface area was measured at 4 time points.

For all 266 patients in the study, the wounds were evaluated based on number of days to reach three well-defined wound healing stages:

  • Clean Wound
  • Onset of Granulation
  • Onset of Epithelialization

By measuring the time to reach specific stages in the early healing process it was possible to compare wounds of different size and pathology. A large number of clinical studies have demonstrated that the early healing rate is predictive of the time to complete wound closure (see Cardinal et al. 2008 for a review). The time needed to reach specific stages in the wound healing process could therefore be used as a surrogate marker for time to full wound closure.

suppurative necrotic phase
granulation phase
epithelialization phase

Close-up pictures of wounds at each of the three wound healing phases.
Arrows indicate A: Suppurative necrotic layers; B: Early granulation tissue; and C: Early epithelial tissue.

 

The three stages that were measured were:

  • Clean Wound: Wounds entering the study were in the suppurative necrotic phase, which consists of alteration and exudation stages and is characterized by the presence of necrotic tissues and purulent contents (originating from infections), oedema and high microbial seeding. The wounds were rated to be clean when they were free from pus and fibrinogenous thickenings.
  • Onset of Granulation: The granulation phase consists of wound cleansing, normalization of microcirculation and metabolic processes in tissues, and granulations formation. The wounds were rated to have reached this stage, when the first presence of granulation tissue was detected.
  • Onset of Epithelialization: The wounds were rated to have reached this stage, when the first presence of young skin, i.e. epithelial tissue growth, was detected. At this stage the wound shows stable progressive epithelialization and active reduction of wound size.

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Clinical evaluation in patients with dehisced surgical wounds - Additional details

MPPT was evaluated in a clinical audit at Bristol University Hospital on 9 dehisced surgical wounds and a category 4 pressure ulcer. Several of the wounds displayed more than 40% slough and signs of local infection. MPPT rapidly lifted the slough off and facilitated a rapid build-up of granulation tissue such that the wounds continued towards full closure much faster than normal. An average of 3 applications was used on the wounds to reach a clean actively healing wound. According to the responsible TVN, these wounds would normally have required 1 week with UrgoClean to remove the slough followed by 2 or more weeks with TNP (topical negative pressure) to reach the same stage as that achieved with 3 applications of MPPT. None of the wounds became chronic.

See Abstract