A Standardized Procedure of Dressing Management for Toxic Epidermal Necrolysis

Summary

This is a standardized dressing protocol for patients with toxic epidermal necrolysis. This robust protocol utilizes silver ion dressings designed to accelerate healing and alleviate pain, minimizing hospital stays.

Abstract

Toxic epidermal necrolysis (TEN) is a severe cutaneous adverse drug reaction with high mortality rates, demanding specialized wound care to address epidermal detachment and bullae formation. This study summarizes a standardized dressing management protocol to enhance the healing process, reduce complications, and improve patient comfort during dressing changes for TEN patients. The protocol emphasizes a systematic approach to patient preparation, environmental control, and the utilization of silver-ion-based dressing materials. Specifically, it integrates gentle cleansing techniques with a warmed povidone-iodine saline solution, precise necrotic tissue removal, and silver sulfadiazine lipid hydrocolloid dressings to maintain an optimal healing environment. The effectiveness of this protocol was further validated through a retrospective analysis, which showed a significant reduction in the onset of re-epithelization, wound healing time, and hospital stays, resulting in diminished pain during dressing changes. Furthermore, this protocol also provides tailored strategies for dressing changes in sensitive areas, ensuring comprehensive care. The standardized protocol streamlines the dressing process and contributes to more efficient allocation of healthcare resources, establishing a robust foundation for TEN treatment that can be adopted in clinical practice and inform future research.

Introduction

Toxic epidermal necrolysis (TEN) is a severe cutaneous adverse drug reaction, distinguished by widespread epidermal detachment and bullae formation, which confers an increased susceptibility to complications such as infections and derangements in fluid and electrolyte balance¹. This condition invariably precipitates a host of complications, notably infection and fluid and electrolyte imbalances, with the severity of TEN being inextricably linked to the manifestation and progression of such complications. The literature has documented that TEN mortality rates span from 12% to 30%². Areas of diffuse erythema are seen in TEN, with individual macular lesions at the periphery. Large, flaccid blisters are formed from the detachment of the epidermis from the underlying dermis. The roofs of the blisters turn necrotic and large 5 cm sheets show denudation of the epidermis³. The efficacious management of TEN is predicated upon the prompt discontinuation of the inciting drug regimen and meticulous wound care⁴. Of particular note, wound care assumes a central position in the treatment paradigm for TEN patients. Its principal objectives are to stanch occult fluid loss, forestall the onset of sepsis, and foster epithelial regeneration⁵. The overarching principles governing wound care encompass safeguarding the underlying exposed dermis, attenuating the potential for infection, mitigating the risks of pigmentary alterations and scarring, and optimizing the process of epithelial reformation. More specifically, wound care resides within the purview of surgical debridement, and its operational modalities entail selecting either debridement procedures or supportive dressings. This translates into either the excision of detached and necrotic epidermal tissues or the retention of viable epidermis as a biological dressing, followed by the application of supportive dressings to facilitate epithelial reformation⁴.

The extensive skin lesions associated with TEN are particularly susceptible to being invaded by microbes such as bacteria, fungi, and other pathogens⁶. Conventional dressings, such as gauze and cotton pads, exhibit limited water absorption capabilities and have a propensity to adhere to wound surfaces, leading to iatrogenic trauma, exacerbated pain levels, and bleeding during dressing changes⁷. These materials provide inadequate air permeability, which impedes wound healing⁸. Furthermore, traditional dressings are ineffective at preventing and managing infections, increasing the risk of wound sepsis⁹. Their inability to facilitate wound healing results in prolonged convalescence, increased patient discomfort, and higher healthcare costs¹⁰.

Novel dressings, such as zinc oxide talcum powder wraps and silver ionic dressings, have been investigated for TEN management¹¹. Notably, silver sulfadiazine lipid hydrocolloid dressings dressing, a typical silver ionic dressing that sustains the release of silver sulfadiazine, has shown promise in maintaining adequate antibacterial levels, promoting a moist healing environment, and decreasing irritation and pain during dressing changes^12,13,14,15. Recent studies suggest that silver sulfadiazine lipid hydrocolloid dressings can reduce healing time, infection rates, and patient discomfort compared to traditional dressing^16,17. However, standardized dressing change protocols still need to be developed for TEN patients.

At present, there is a lack of standardized protocols for the wound care of patients with toxic epidermal necrolysis (TEN). Moreover, wound management practices differ among various medical units. Consequently, the establishment of standardized wound management for TEN patients constitutes a crucial yet unfulfilled clinical priority¹⁸. The primary aim of this research is to standardize the wound dressing change procedures for TEN patients. Specifically, it endeavors to compare the wound healing time between two different dressing change regimens: one centered around silver sulfadiazine liposome hydrocolloid dressing, and the other being the conventional dressing change approach. The secondary objective is to investigate the efficacy of silver sulfadiazine liposome hydrocolloid dressing in facilitating wound healing in these patients.

Protocol

All procedures performed in this study comply with the ethical standards of the First Affiliated Hospital of Chongqing Medical University and the Declaration of Helsinki and its later amendments or similar moral standards. This study was approved by the ethics committee of Chongqing Medical University (Number: 2024-155-01), Participants were informed of the process, content, and possible medical phenomena before the start of the trial to ensure their right to know. Patients and their families were consulted to determine their willingness to participate in the trial activities. Before the enrollment of this patient, their informed consent for the use of photographs and participation in this research was obtained. This dressing management protocol was primarily designed for patients diagnosed with TEN. However, this protocol is also applicable for patients with extensive body areas of epidermolysis, such as pemphigus, bullous pemphigoid, and epidermolysis bullous.

1. Preparations

1. Environmental preparation
   1. House the patient in a single room with protective isolation, maintaining it at 25-28 °C and 40-50% humidity, with daily UV irradiation and ventilation. Place a far-infrared grill 30-50 cm from the patient for 30-60 min sessions to treat trauma; allow them to adjust their position for optimal exposure.
   2. Disinfect the room, including the floor and bed, using a 500 mg/L chlorine solution twice daily.
   3. Ensure that the bed is an antibedsore inflatable mattress with sterile sheets, sterile cotton pads, and disposable nursing pads. Use whole-body exposure therapy with disinfected quilt frames during dressing changes to minimize epidermal stripping.
      NOTE: Disposable nursing pads were used to prevent fluid seepage.
2. Patient preparation
   1. For bedridden patients, carefully rinse and dress localized skin breaks without moving them from the bed.
   2. For ambulatory patients who can stand by the bedside, place a medical waste bag beneath their feet to ensure that garbage and liquids are collected and flushed.
      NOTE: This precaution prevents the ward floor from getting wet due to rinsing fluid.
3. Material preparation
   1. Keep essential items ready, including a treatment trolley, sterile gauze rolls, gloves (both sterile and film), empty needles, a dressing change box with sterile scissors, and medical swabs.
      1. Ensure the dressing change box contains large and small gauze blocks, Bactroban ointment, fu fang comfrey oil, povidone-iodine, 0.9% sodium chloride in 500 mL bottles, silver sulfadiazine lipid hydrocolloid dressings, rb-bFGF, sterile cotton pads, duvet covers, pillowcases, and petroleum jelly oil gauze.
   2. Keep personal protective equipment ready-disposable sterile surgical gowns, caps, shoe covers, masks, and household and medical garbage bags.

2. Skin cleansing and disinfection

1. Prepare the cleaning solution by mixing povidone-iodine with bottled saline in a 1:9 ratio. Warm the mixture in hot water to achieve a temperature of approximately 35 °C.
   NOTE: The mixture's temperature should be based on the patient's comfort. Iodophor primarily functions as a disinfectant and sterilizing agent. If a patient is allergic to iodophor, its use can be selectively considered depending on the severity of the allergy. Nevertheless, chlorhexidine can serve as an alternative.
2. Assess the patient's condition to ensure the cleaning technique is suitable.
3. Remove the previous dressing by moistening it with ozone water to facilitate detachment from the skin.
4. Clean the patient's entire body using the prepared povidone-iodine saline solution and gently dry the patient's skin using a large sterile gauze.
   1. For the first dressing change, rinse the lesion area with the povidone-iodine saline solution.
      NOTE: There is no need to remove all the necrotic epidermis entirely. Just wait for them to fall off naturally. When removing previous dressings, if the dressing adheres to the skin tightly, avoid forceful separation to prevent damage to the delicate neonatal epithelium.
5. Use far-infrared thermal retention devices throughout the process to warm the patient and protect against chill¹⁹.

3. Dressing change procedures

1. Dressing change at the erythema and bullae stage
   NOTE: Preserve the skin's integrity to improve the protective barrier and prevent secondary skin infections. Avoid forcibly removing extensive bullae and loosened epidermis; leave them in place to serve as biological dressings.
   1. In cases in which the epidermis has been shed and there is debris, gently remove necrotic tissue and debris that can be easily detached without force.
      NOTE: In step 2.3, when the previous dressing is moistened with ozone water, the necrotic, detached epidermis would come off with the removal of gauze or can be gently removed by hand.
   2. Preserve the unpeeled skin tissue (the ruptured epidermis that is not removable along with gauze). Use sterilized scissors to remove any loose or peeling skin tissue.
   3. Leave small bullae and those with minimal exudate untreated, keeping the bullae wall intact for natural absorption.
   4. For large bullae >2 cm in diameter filled with fluid, apply iodophor for sterilization. Then, use a 2 mL sterile syringe to aspirate the fluid from the bullae through a low puncture, and send the fluid for bacterial and fungal cultures. Alternatively, use a surgical blade to make a small incision at the lowest point of the bullae for natural drainage.
   5. Overlay with sterile gauze.
2. Dressing change at the exfoliation stage
   1. Confirm that the patient's epidermis is loose and exfoliated, with associated exudation and increased pain.
   2. Use the Numerical Rating Scale to assess the patient's pain level.
   3. To alleviate discomfort, administer 100 mg of Tramadol intramuscularly 30 min before dressing changes.
   4. Measure the dimensions and contour of the skin lesion to determine the appropriate dressing size.
   5. Apply Silver Sulfadiazine Lipid Hydrocolloid dressing, ensuring complete coverage and extending 0.5 to 1 cm beyond the wound margin.
   6. Saturate a substantial sterile gauze block with comfrey oil and Bactroban ointment and place it on the silver ion dressing.
   7. Overlay with sterile gauze and secure with sterile cotton pads.
      NOTE: Avoid using tapes that adhere directly to the skin, which will tear the skin when changing dressing. Instead, sterile cotton pads, like clothes, should cover the whole body.
3. Dressing change at the reepithelization stage
   1. Observe that the skin is in the reepithelization stage, showing a tendency to heal but remaining fragile.
   2. Discontinue using silver sulfadiazine lipid hydrocolloid dressings and switch to rb-bFGF to accelerate the healing process.
      NOTE: Protect the newly formed skin tissues by avoiding any actions that could cause dragging, pulling, or tugging.
   3. Implement a bi-hourly axial turnover to reduce the risk of developing pressure ulcers due to prolonged contact pressure.

4. Efficacy and number of dressing changes

1. In cases of profuse exudates, replace the dressing 1-2x daily. Conversely, if the exudate is scant, change the dressing every 2-3 days.
2. The three stages mentioned above could exist simultaneously. Monitor the patient's skin condition and adjust care procedures to support the healing process effectively.
3. Closely monitor the exudate from cutaneous lesions, documenting its volume, color, and odor. Repeat the previous procedures if necessary. Adhere to the following standardized protocol during dressing changes: initial disinfection, subsequent cleansing, thorough drying, and applying a new dressing.

5. Dressing change at particular sites

1. Mouth and lips
   1. To alleviate oral discomfort, use a 5% sodium bicarbonate solution and lidocaine for gargling.
   2. Apply thick Bactrim or erythromycin ointment to the lips for local antiseptic and protective effects.
   3. Oral hygiene practices
      1. Advise patients to avoid keeping their lips closed for long durations.
      2. Encourage patients to open their mouths frequently to reduce the risk of secondary chapping and promote healing.
2. Ocular area
   1. In cases where a patient presents ocular symptoms, advise them to consult an ophthalmologist to assess the condition.
   2. Flush the conjunctival sac of the eyelid daily with 0.9% sodium chloride to maintain cleanliness.
   3. Cleanse the eye promptly of pseudo membranes and inflammatory secretions using sterile cotton swabs.
   4. Administer Tobramycin and levofloxacin eye drops 4x daily to treat ocular infections and inflammation.
   5. Cover both eyes with petroleum jelly gauze for a patient incapable of closing their eyes.
      NOTE: Regularly covering both eyes with petroleum jelly gauze is also recommended for regular patients.
3. Perineum
   1. Perform daily perineal irrigation with a saline solution to maintain hygiene.
   2. After irrigation, apply silver sulfadiazine lipid hydrocolloid dressings dressing to the affected skin lesions.
   3. Wrap the area with comfrey oil gauze.
   4. Advise male patients to use comfrey oil gauze to separate the penis from the scrotum to prevent adhesion and facilitate healing.

Results

We retrospectively compared the outcomes of this new method (based on silver sulfadiazine lipid hydrocolloid dressings dressing) with the conventional method (which did not involve silver sulfadiazine lipid hydrocolloid dressings dressing or sterile cotton pads) throughout the years 2023-2024. Sixty patients with toxic epidermal necrolysis (TEN) from the Dermatology Department of the First Affiliated Hospital of Chongqing Medical University were enrolled for statistical analysis. Mean values, standard deviations (SD), an...

Discussion

TEN is a rare but devastating drug reaction characterized by extensive skin detachment affecting more than 30% of the body's surface area and the mucous membranes¹⁸. TEN is associated with severe complications, like sepsis with a mortality rate of 14%-30%. It has been reported that mortality is strongly linked with the areas of detached skin because the widespread skin bullae significantly increases the risk of infection due to the loss of the protective skin barrier²⁰....

Materials

Name	Company	Catalog Number	Comments
0.9% sodium chloride	SOUTHWEST PHARMACEUTICAL Co.,Ltd.
Bactroban ointment	Tianjin Shike Pharmaceutial Co.,Ltd.
Disposable Medical Kit (a dressing change box with sterile scissors)	Zhende Medical Co.,Ltd.	GB/T HYA-15
Fu fang Comfrey oil	Jian Min Ji Tuan Ye KaiTaiGuoYao Co.,Ltd.	GBZ20044385
Medical  Swab	Zhende Medical Co.,Ltd.	6926515436841
petroleum jelly oil gauze	Henan PiaoAn Group Co.,Ltd.	GB20153140848
Povidone-iodine	SHANDOING LIERKANG TECHOLOGY Co.,Ltd.
rb-bFGF	ZHU HAi Yi SHENG  BIOLOGICAL MEDICAL Co.,Ltd.	GBS1098077
silver sulfadiazine lipid hydrocolloid dressings	LABORATOIRES URO	3546895089623
Single-Use Sterile Rubber Surgical Gloves (both sterile and film)	SHANDOING YU YUAN RBBER GLOVES Co.,LTD	GB/T 7543-2020
Sterile Dispensing Syringe for Single Use (empty needles)	SHANDON WEIGAO GROUP MEDICAL POLYER Co.,LTD	GB/T 20142140076
sterile gauze rolls	Zhende Medical Co.,Ltd.	6959385745812