Overview

Control More, Change Less

Unique Exudate Management Technology Makes Wound Care Easier

TIELLE™ AND TIELLE™ Plus Hydropolymer Adhesive Dressings are fluid handling systems. As exudate is absorbed by the dressing, the hydropolymer central island expands and conforms to the contours of the wound - minimizing exudate build-up and the chance of maceration. Excess moisture is held in the wicking layer next to the polyurethane backing. The vapor-permeable backing allows excess moisture to evaporate through the back of the dressing. As the exudate evaporates, the TIELLE™ or TIELLE™ Plus Hydropolymer Dressing is able to manage additional exudate, until the dressing reaches its absorbent capacity.

TIELLE™ AND TIELLE™ Plus: There when you need it

The Technology

Mode of Action

Features	Benefits93
Innovative Product Composition	Maintains a moist wound environment TIELLE™ Dressings require 9% fewer changes versus a hydrocolloid Controls leakage and odour more effectively than hydrocolloids
Polyurethane Backing	Water resistant and vapor-permeable to help protect wound from exogenous bacteria and contaminants
Nonwoven Wicking Layer	TIELLE™ Plus absorbs up to 15 times its own weight in fluid Removes excess moisture from wound site
Hydropolymer Central Foam Island	Fills wound cavity as it absorbs May be left in place for up to seven days Requires no secondary dressing or tape Will not melt down into wound bed like a hydrocolloid
Gentle Adhesive Border	Easy to apply and more comfortable for the patient than hydrocolloids

Indications

TIELLE™ and TIELLE™ PLUS Hydropolymer Adhesive Dressings should be used under health care professional direction for the following indications:

• Pressure ulcers
• Lower extremity ulcers
  • Venous
  • Arterial
  • Mixed etiology
• Diabetic ulcers
• Donor sites

TIELLE™ and TIELLE™ PLUS Hydropolymer Adhesive Dressings are suitable for use under compression bandaging.

How to use

Preparation

Prepare the wound according to wound management protocol. Ensure skin surrounding the wound is dry.

Application

Position the dressing with the absorbent island placed centrally over the wound site . One at a time, peel away the side backing papers while smoothing adhesive border onto intact skin.

Techniques

A. Digit Dressing
B. Heel Dressing
C. Overlap for Large Wounds
D. Sacral Dressing

Changing

Change the dressing when wound fluid is present at the edges of the hydropolymer central island. Do not allow exudate to accumulate under the backing.

Upon removal lift one corner and carefully peel back. On fragile or friable skin, water or saline may be used to break the adhesive seal.

It is essential for proper wound management to avoid trauma to the intact skin.

Technique for Additional Water Repellancy

After the application of TIELLE™ Adhesive Dressing, petroleum jelly or other petroleum based product can be applied to the edges of the dressing and surrounding skin.

Package insert

• IFU TIELLE™
• IFU TIELLE™ Plus

TIELLE™

TIELLE™ Hydropolymer Adhesive Dressing provides an exudate handling system for low to moderately exuding wounds. It is a highly absorbent dressing. The absorbent material is a synthetic polymer.

The island dressing maintains a moist environment that aids in the wound healing process and allows granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate. It allows the wound to remain moist thus encouraging autolytic debridement which may initially increase lesion size. This is normal and to be expected prior to wound granulation.

Indications

TIELLE™ Dressing is indicated for the management of low to moderately exuding wounds. TIELLE™ Dressing should be used under health care professional direction for the following indications:

• Pressure ulcers
• Lower extremity ulcers
  • Venous
  • Arterial
  • Mixed aetiology
• Diabetic ulcers
• Donor sites

TIELLE™ Dressing is suitable for use under compression bandaging.

Precautions

TIELLE™ Dressing is not indicated for use on the following:

• Third-degree burns
• Lesions with active vasculitis as this type of ulcer needs more frequent observations by a healthcare professional.

TIELLE™ Dressings may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.

Directions for use

Site preparation

1. Prepare the wound according to wound management protocol.
2. Ensure skin surrounding the wound is dry.

Dressing application

The size of the dressing selected should allow the absorbent island to overlap the wound edge by approximately 1cm.

1. Peel open the package and remove the dressing.
2. Partially peel back side backing papers. Position absorbent island centrally over wound site and smooth in place.
3. One at a time, peel away side backing papers while smoothing adhesive border onto intact skin.

Dressing change and removal

It is essential for proper wound management to avoid trauma to the intact skin.

1. Change dressing when wound fluid is present at the edges of the foam pad. Do not allow exudate to accumulate under the backing. The dressing may be left in place up to 7 days depending upon the amount of exudate.
2. On removal lift one corner and carefully peel back. On fragile or friable skin, water or saline may be used to break the adhesive seal.

Do not use if individual pack damaged/opened.
Do not resterilize.
The use by date of this product is printed on the packaging.

Caution: Federal [U.S.] Law restricts this device to sale by or on the order of a physician [or properly licensed professional]. This caution is not applicable outside the U.S.

Leaflet prepared: February 2001

TIELLE™ Plus

TIELLE™ Plus Hydropolymer Adhesive Dressing provides a dynamic exudate handling system with a highly absorbent internal wicking layer for regulating moisture from moderate to heavily exuding wounds. During use the absorbent island gently expands as it takes up exudate. The island dressing maintains a moist environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under the optimum conditions. This may initially increase lesion size, which is normal and to be expected prior to wound granulation.

Indication

TIELLE™ Plus Dressing is indicated for the management of moderate to heavily exuding wounds.

TIELLE™ Plus Dressing should be used under health care professional direction for the following indications:

• Pressure ulcers
• Lower extremity ulcers
  • Venous
  • Arterial
  • Mixed aetiology
• Diabetic ulcers
• Donor sites

TIELLE™ Plus Dressing is suitable for use under compression bandaging.

Precautions

TIELLE™ Plus Dressing is not indicated for use on the following:

• Third-degree burns
• Lesions with active vasculitis as this type of ulcer needs more frequent observations by a healthcare professional.

TIELLE™ Plus Dressings may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.

Directions for use

Site preparation

1. Prepare the wound according to wound management protocol.
2. Ensure skin surrounding the wound is dry.

Dressing application

The size of the dressing selected should allow the absorbent island to overlap the wound edge by approximately 1cm.

1. Peel open the package and remove the dressing.
2. Partially peel back side backing papers. Position absorbent island centrally over wound site and smooth in place.
3. One at a time, peel away side backing papers while smoothing adhesive border onto intact skin.

Dressing change and removal

It is essential for proper wound management to avoid trauma to the intact skin.

1. Change dressing when wound fluid is present at the edges of the foam pad. Do not allow exudate to accumulate under the backing. The dressing may be left in place up to 7 days depending upon the amount of exudate.
2. On removal lift one corner and carefully peel back. On fragile or friable skin, water or saline may be used to break the adhesive seal.

Do not use if individual pack damaged/opened.
Do not resterilize.
The use by date of this product is printed on the packaging.

Caution: Federal [U.S.] Law restricts this device to sale by or on the order of a physician [or properly licensed professional]. This caution is not applicable outside the U.S.

Leaflet prepared: February 2001

Evidence

The TIELLE™ family of dressings has been extensively tested in multiple randomized controlled trials and post-market studies.

The effect of successfully managing exudate is shown in the overwhelmingly positive results achieved consistently across the major wound types and different exudate levels in thousands of patients.^{57, 59, 60, 61}

For example:

• 58% chronic wounds healed (diabetic, pressure ulcer, leg ulcer) using TIELLE™ after 12 weeks (results for 2,187 patients)⁶¹.
• 100% healing for TIELLE™ Lite in acute wounds after four weeks⁶⁰.

The patients' experience

The patients' ability to live with the dressing is also vital.

• TIELLE™ adhesive dressings can be worn in the shower.
• Flexible, soft to touch.⁶²

TIELLE™ adhesive dressings have a unique gel adhesive.

• No adhesive over wound margin.
• Stays in place without adhering to wound bed.⁶⁰
• Easy to remove without trauma⁵⁸ or pain.⁵⁹

The bottom line

Cost-effective wound care relies on reducing the time to healing but also on reducing the number of dressing changes needed. TIELLE™ provides a cost-effective solution, with proven wear time in practice of four days⁵⁹ in typical use and up to seven days.

Order Information

TIELLE™ Hydropolymer Foam Dressing

Code	Description	Packaging	Eaches
MTL100	7 cm x 9 xm	10 eaches/box	10
MTL101EN	11 cm x 11 cm	10 eaches/box	10
MTL102	15 cm x 20 cm	5 eaches/box	5
MTL103	18 cm x 18 cm	5 eaches/box	5
MTL104	18 cm x 18 cm SACRUM	5 eaches/box	5
MTL105	15 cm x 15 cm	10 eaches/box	10

TIELLE™ PLUS Hydropolymer Foam Dressing

Code	Description	Packaging	Eaches
MTP501	11 cm x 11 cm	10 eaches/box	10
MTP502	15 cm x 20 cm	5 eaches/box	5
MTP505	15 cm x 15 cm	10 eaches/box	10
MTP506	15 cm x 15cm SACRUM	10 eaches/box	10
MTP508	26.5 cm x 20 cm HEEL	5 eaches/box	5

TIELLE™ MAX Non-Adhesive Hydropolymer Foam Dressing

Code	Description	Packaging	Eaches
MTP701	11 CM x 11CM	10 eaches/box	10
MTP702	15CM x 20CM	5 eaches/box	5
MTP705	15 CM x 15CM	10 eaches/box	10