Burn wound is probably the most devastating of all the wounds – physically, psychologically, socially and economically. Early, expedious burn wound closure is crucial for survival of patients with large burn wounds. After successful initial management, burn wound infection leading to systemic sepsis is the single most major cause of death in burn patients – especially in India. Existence of burn wound causes,
- Loss of barrier to bacterial invasion.
- Hyper metabolism with consumption of body proteins leading to severe catabolic state
- Immuno-suppresion, which is directly proportional to the extent of burn.
- Disturbance of temperature regulation.
- Possibility of deformities and disfigurement.
For partial thickness burn wound (that involves destruction of epidermis and variable extent of dermis) the natural process of wound healing can be aided and / or expedited with appropriate use of several biological wound covers (e.g. collagen, amnion, banana leaf dressing, etc.) or interactive wound dressings (e.g. Acticoat) and topical agents (e.g. antimicrobial creams, E G F containing preparations, etc.) The healing usually takes about 10-20 days. The scar is acceptable.
But, for full thickness burn wound, split thickness skin grafting is the only way of obtaining wound closure. Patients with burn size upto 40-50% Total Body Surface Area (TBSA) can usually be provided permanent closure of such wounds with skin autografts obtained from the unburnt areas of the patient. But, with larger burn size, several factors preclude autograft procurement
- Poor general condition of patient.
- Paucity of autograft donor sites.
- Risk of increase in the size of wound due to addition of donor site wound to the extent of burn wound and its consequences.
- Risk of loss of autografts due to sub optimal recipient bed and general status.
- Duration needed (usually 3 weeks) for reharvesting skin graft from same donor sites.
In these situations, the only way of salvaging such patients is using substitutes for skin autografts such as.
- Xenografts (from other species e.g. pig-skin)
- Allografts (from another human being)
- Biosynthetic skin substitutes (Artificial Skin)
These skin substitutes provide temporary but long term wound closure, with potential to save life of a patient with large burn.
Xenografts are not commercially available in our country. Biosynthetic skin substitutes are extremely expensive and unaffordable for most of the burnt patients in our country. The availability is also uncertain. Then the only alternative available is Skin Allografts obtained from a human donor. The efficacy of skin allografts in the management of burn wound was realized in 1881.These have also been shown to be the most effective of the alternatives. In Western countries, besides better facilities and resources, one of the main reasons for salvage of patients with very large burn (e.g. 95% of TBSA) is availability of skin homografts.
Skin Allograft Donors can be
- 1 .Living Donor :-For procurement of Skin grafts, the living donor needs to undergo a battery of investigations for preoperative evaluation followed by a surgical procedure under suitable anesthesia, hospitalization for atleast 2-3 days, donor site healing time of about 10 days and postoperative wound site pain. Maximum body surface area that can be safety utilized for harvesting of skin grafts is 15 to 20% at a time. To avoid vested interests and commercial angles – it is advisable to use only close relatives as living donors. In the present age of nuclear families availability of such a relative is obviously very rare and inconvenient too. It is even more difficult to come across a willing donor for a young female patient. In reality, majority of our patients are young females from poor socioeconomic strata with compromised nutritional status and have large burn size (average extent more than 50% TBSA) with most of the area bearing full thickness burn wound. So the problem is obviously challenging.
The other alternative is to procure split thickness skin grafts from a cadaver donor and preserve them for use in future.
- 2 .Cadaver Donor :-The concept of skin donation after death is not new and the first skin bank was established in USA around 1950. The chief benefits of use of allografts on excised full thickness burn wounds are
- Effective control of protein and fluid loss from wounds.
- Reversal of hypermetabolic state with improvement in nutritional status.
- Augmentation of immunological response.
- Control of wound infection and improvement in the wound bed making it ready for acceptance of precious skin autografts.
- Immediate pain relief and general feeling of well being.
- Excellent biological wound cover till the autograft donor sites become ready for reharvesting.
The skin allograft transplant differs from organ transplantation as the skin grafts are used to provide temporary long term protection and are not expected to survive in the recipient permanently as transplanted organ. This means that neither ABO blood group nor HLA matching is required for allograft skin transplantation. So, literally any human being can be a donor for anyone else.
The need for skin allografts is not likely to be perceived unless the burn center is a high volume unit with ability to salvage most of the patients with upto 50% TBSA burns.
At this stage the unit will be forced to think of ways to salvage patients with larger than 50%TBSA burns. This was what exactly happened at the burn unit at L t M General Hospital, Sion. When I was entrusted with the responsibility of the burn unit in 1989, the L.A. 50% (L.A. 50 is the burn extent at which 50% of patients are expected to succumb to the burn injury) was of 35 % TBSA. With dedicated team efforts this progressed to 50% TBSA by 1995. Availability of skin substitute was crucial for continued progress.
During my training in burn care at burn centre in Denmark in 1990, I had assisted in the final skin grafting procedure of a patient with 95% TBSA burns. That patient was salvaged only due to use of allografts from the skin bank in the unit. By then the Euro skin bank at Beverwick in Netherlands had been functional for several years and was providing skin to burn centers in Europe. The time that I spent at both these centers had convinced me of the utility of allograft skin and skin banking. Considering the profile of our burnt patients skin allograft was and is the only suitable skin substitute in my opinion.The paucity of live relative donors and the inconvenience associated with this procedure made it obvious that we had to obtain skin allografts from cadaver donors. In 1998, my visit to Shriner’s burn institute and UTMB tissue bank at Galvaston, Texas, USA provided further stimulus as well as valuable information.
The concept of skin donation after death
Indian Society has been aware of eye donation after death for several decades. But I was making an effort to introduce a completely new concept to our society. The eye donation needs to be procured preferably within 2 hours of death . But skin donation can be taken upto 12 hours and with precautions even upto 24 hours after death. The donation is possible if the deceased person was more than 16 years of age and was not harbouring transmissible infections such as Hepatitis B, Hepatitis C and HIV. Those suffering from skin cancer, septicaemia and with damaged skin e.g. scleroderma, pemphigus; are not suitable donors.
The first step was to seek approval of the appropriate authority to procure skin grafts after death. I was aware of some earlier abortive efforts in this direction and the difficulties faced by the healthcare professionals associated with the field of burn care. I had studied the legal issues related to organ and tissue donation after death .I was confident that split thickness skin graft (which by definition is a tissue) can be procured from a cadaver with the consent of the next of kin. This was possible according to the Bombay Anatomy Act of 1949, that also supports body donation after death. As with any new venture, some discouraging remarks were made and a few contradictory statements with potential to harm the cause were issued by some. But I had the courage of conviction and support of a dedicated team. So with permission from the Head of the institution, a proposal was drafted in early 1999 and was submitted to the state appropriate authority for approval.
The state appropriate authority has been established by Government of Maharashtra to ensure adherence to stipulated guidelines in relation to allogenic transplantation. The concept of skin donation after death was new for the officials as well. Some questions were raised and were resolved satisfactorily. The officials captured the significance of skin donation after death and the need for skin bank. The formalities were completed and the approval letter was obtained within a period of 6 months. This was truly encouraging and augmented the enthusiasm to initiate the new venture.
The next and certainly more difficult task was that of creating awareness about this new concept. This cannot be a onetime activity and constant, ongoing efforts are needed to maintain the level of awareness. I had realized that awareness was needed not only in general population but also amongst the medical fraternity. It was necessary to make use of all the various media for this cause. The activity that was started in the year 2000, is being regularly carried out till today and will continue in future too.
Initially brochures were prepared containing information regarding skin donation after death in three languages. These were and still are being distributed at meetings. Print media have been extremely supportive and articles, interviews are being published at regular intervals in various news-papers and magazines. A power-point presentation explaining the need for skin allografts, process of skin donation after death and utilization of these grafts has been prepared and it is used during lectures and discussions at various group meetings. Till date, I have given more than 50 lectures for several senior citizens’ groups, branches of Rotary club, Lions’ club, social organizations and voluntary groups in different parts of Mumbai. Ardent supporters such as Sunday Friends have made banners and posters and are contributing significantly to this mammoth task of creating awareness. Akashwani Radio stations have helped by airing talks or dial-in programs. Visual impressions probably have better impact. But major ty of the electronic visual media channels have not been enthusiastic in supporting the cause. I could convince the education media research center at Pune to make a short film on this subject. But I have no knowledge of it being aired at any time. Ineffective efforts in identifying appropriate contact person or failure on my part to convey the social relevance of this concept and its benefit to the decision makers, may be some of the reasons for apathy on the part of visual electronic media. This indeed is unfortunate as this medium has the power to make the society experience the devastating effects of burn injury and the benefits derived from use of skin allografts. Television channels can play a pivotal role in elevating the level of awareness about skin donation after death through short, effective and regular messages.
The act of skin donation after death can help save a life ; most often of a young woman of 25 years and this means a family will survive, children will have their mother and the husband his wife. At other time, it may give lease of life to a young man – the only bread winner in the household and the family won’t crumble to pieces.
It is essential to understand the social relevance of this noble act of giving a gift of life even after death. I will elaborate more about actual setting up of the skin bank in the second part of the article.
The decision to start a skin bank with the capability to procure skin donation after death was taken and several activities were initiated. Besides my colleagues from department of surgery, faculty of department of Microbiology especially Dr Daksha Pandit (then Associate professor) contributed significantly to the process of establishing protocols and standardizing the procedures. The department of Microbiology continues to be the integral part of the skin bank team. The actions involved the following :
- Approval from authorities :- The state appropriate authority established by Government of Maharashtra was approached to seek its approval for procuring cadaver skin homografts with consent of next of kin. This request was supported by Bombay Anatomy Act of 1949 that makes body donation after death possible. Though the concept was completely now, the official captured the significance and the need for skin bank. The formalities were completed and the consent letter was obtained within a period of 6 months. This was really encouraging.
- Preparation of Documents :- Late Dr. Pritam Phatnani – then Professor and Head of Department Forensic Medicine was of great help in drafting the consent form in appropriate words. Other forms for maintenance of records such as donor details, graft processing, recipient details, etc were prepared using UTMB tissue bank documents as prototypes.
- Preparation of Protocols:-
The following protocols were prepared after review of references and discussion with all the team members.
- Defining eligibility criteria.
- Communication and response details.
- Readiness of equipment.
- Procurement protocol.
- Transport equipment & protocol.
- Deposition and information routine.
- Homograft and serological processing protocol.
- Storage method and quality control.
- Procedure for requisition and disbursement of homograft.
- Record keeping.
- Space allocation and procurement of equipment While all the above preparation was in progress, a room was identified in the department of surgery and after appropriate approval from administrative authority, the area was made ready for installation of equipment. Some items such as incubator, hot air oven were acquired from MCGM funds. Most of the main storage equipment was received in donation from “Sunday Friends” - a voluntary organization that has been associated with our burn unit for several years.
- Work distribution:Awareness, Counseling , procurement and utilization – Department of Surgery.Processing , banking, disbursement – Department of Microbiology.Funding – Donation from Voluntary organization, M.C.G.M.
- Equipment : The details regarding equipment and personnel may be of help to an institution interested in setting up a skin bank. Depending on the choice of preservation technique, the required equipment would vary in certain details.
a) Instruments for skin graft procurement - Rs. 50,000 – 00
b) Dermatome ( optional ) - Rs. 5,00,000 - 00
c) Refrigerator - Rs 10,000 – 00
d) Incubator - Rs. 20,000 – 00
e) Ultra-cool refrigerator for -70 o C temperature - Rs. 7,00,000 - 00
f) Laminar flow cabinet - Rs. 2,00,000 - 00
g) Air conditioners - Rs. 3,00,000 - 00
h) Universal power supply Rs 1,00,000 - 00
i) Laboratory articles, reagents, chemicals, furniture – 1,00,000 – 00
The total initial expenditure to equip the skin bank is about Rs. 20,00,000 – 00
The cost of consumables needed for procuring skin donation from one donor is about Rs. 2000 – 00 and this includes the cost of serological testing.
The institutional infrastructure has to contribute to activities such as central sterile supply, serology and microbiological testing, graft antibiotic treatment and sterility testing. A stand alone skin bank will have to arrange these provisions.
- Personnel :The functioning of skin bank depends on the dedication and commitment of personnel in the skin bank team. From available persons we need to identify counselor, contact person, response team including surgeon, assistant, helper and supervising consultant. The laboratory processing has to be entrusted to identified microbiologist or biochemist. A record keeper is of great assistant in maintaining documents and record of purchases. Each member of the team needs to be briefed about his/ her responsibility as well as that of others.
- Records :Donor record with all lab reports, graft record, recipient record, communication with donor’s family, filing of donor declaration forms with registration number, answers to questions regarding skin bank – all need to be attended to by identified person.
All the above actions were completed ( preparation time about 6 months) before declaring the Skin Bank open.
Donor : It was decided that any person above the age of 16 years will be accepted as skin donor after death if behavioral and medical history and serological testing of the deceased ruled out the following conditions.
- Hepatitis B or C, HIV I / II, Transmissible diseases.
- Skin cancer, skin infections, damaged skin.
- Systemic sepsis.
Consent : Consent for skin donation is obtained from the closest prioritized relative after explaining the procedure.
Skin graft procurement : This should be done with shortest delay after death, though it can be procured upto 24 hours after death if the body is preserved in cold storage. Prolonged delay causes bacterial and fungal colonization of the donor skin. The procurement should be conducted with aseptic precautions in operation theater when possible. If this is impractical, the procedure can be carried out in the side room of ward, hospital bed , morgue or home of the deceased. The procedure takes about one hour and involves removal of epidermis along with superficial layers of dermis from both thighs and back of the donor. There is no bleeding as blood circulation stops at death. The thighs are covered with dressing before handing over the body to relatives. About 10 ccs of blood of the deceased is collected at the same time for serological testing The grafts are transported to the skin bank in Phosphate buffered saline in glass containers placed in ice box along-with blood sample for serology. The microbiologi t is informed and the processing is initiated. Process details can be provided to interested personnel.
Graft storage : If serology and microbiology reports are satisfactory, the grafts are shifted to -70 0 C. with 15% Glycerol as cryo-protectant. The grafts can be preserved upto 6 months at this temperature. Liquid Nitrogen technology permits preservation upto 3 years. But the present mismatch between availability and requirement does not necessitate the need for methods for prolonged storage. The grafts are thawed to room temperature before use and once thawed, restorage is not recommended.
The response :From April 2000 to 30 th September 2007 , skin donation after death has been received from 82 donors. Grafts from 3 donors had to be discarded due to positive serology. The donation was procured from 58 men and 24 women. The age range was from 16 to 99 years. 32 donors were less than 50 years of age and 31 were more than 70 years old . The procurement was within 6 hours of death of majority of donors and the location of procedure was home in 21, L.T.M.general hospital in 42 and other hospitals in 19 donors. Till date the skin allografts have been used for 47 patients all with burn extent of more than 40% total body surface area. The greatest burn size of the survivor amongst the recipients was 85 % TBSA. Three of the recipients could not be salvaged.
The future :The awareness in the medical fraternity needs to be augmented so that the relatives of the deceased would be counselled. More efforts are called for in stimulating participation of teaching institutions, peripheral hospitals and private hospitals for counseling of relatives after death of a patient in respective institutions.Participation of voluntary organization needs to be co-ordinated. The facility for skin banking should ideally be available in every medical college hospital as maximum numbers of burnt patients seek treatment at these institutions. Several collection centers can be affiliated to each skin bank facility. Training in standardized graft procurement protocol can be provided to available personnel.
It is essential to ensure the quality in functioning of skin bank. Establishment of Tissue bank Association of India would be the logical step in right direction. This will provide guidelines and assistance in quality control.
Appeal : Work of this magnitude cannot be done single-handed. Department of Surgery , LTM Medical College has made a beginning and our experience shows that Indian society has accepted the concept. Now we seek active support and participation of all medical professionals and alert citizens in promoting the concept and in saving lives of several young and productive members of our society.