Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial
Abstract Background Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the last decade hydrosurgery has become popular as a new tool for tangenti...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-04-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2599-2 |
| _version_ | 1818306657453604864 |
|---|---|
| author | Catherine M. Legemate Harold Goei Esther Middelkoop Irma M. M. H. Oen Tim H. J. Nijhuis Kelly A. A. Kwa Paul P. M. van Zuijlen Gerard I. J. M. Beerthuizen Marianne K. Nieuwenhuis Margriet E. van Baar Cornelis H. van der Vlies |
| author_facet | Catherine M. Legemate Harold Goei Esther Middelkoop Irma M. M. H. Oen Tim H. J. Nijhuis Kelly A. A. Kwa Paul P. M. van Zuijlen Gerard I. J. M. Beerthuizen Marianne K. Nieuwenhuis Margriet E. van Baar Cornelis H. van der Vlies |
| author_sort | Catherine M. Legemate |
| collection | DOAJ |
| description | Abstract Background Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the last decade hydrosurgery has become popular as a new tool for tangential excision. Hydrosurgery is generally thought to be a more precise and controlled manner of burn debridement leading to preservation of viable tissue and, therefore, better scar quality. Although scar quality is considered to be one of the most important outcomes in burn surgery today, no randomized controlled study has compared the effect of these two common treatment modalities with scar quality as a primary outcome. The aim of this study is, therefore, to compare long-term scar quality after hydrosurgical versus conventional tangential excision in deep dermal burns. Methods/design A multicenter, randomized, intra-patient, controlled trial will be conducted in the Dutch burn centers of Rotterdam, Beverwijk, and Groningen. All patients with deep dermal burns that require excision and grafting are eligible. Exclusion criteria are: a burn wound < 50 cm2, total body surface area (TBSA) burned > 30%, full-thickness burns, chemical or electrical burns, infected wounds (clinical symptoms in combination with positive wound swabs), insufficient knowledge of the Dutch or English language, patients that are unlikely to comply with requirements of the study protocol and follow-up, and patients who are (temporarily) incompetent because of sedation and/or intubation. A total of 137 patients will be included. Comparable wound areas A and B will be appointed, randomized and either excised conventionally with a knife or with the hydrosurgery system. The primary outcome is scar quality measured by the observer score of the Patient and Observer Scar Assessment Scale (POSAS); a subjective scar-assessment instrument, consisting of two separate six-item scales (observer and patient) that are both scored on a 10-point rating scale. Discussion This study will contribute to the optimal surgical treatment of patients with deep dermal burn wounds. Trial registration Dutch Trial Register, NTR6232. Registered on 23 January 2017. |
| first_indexed | 2024-12-13T06:45:58Z |
| format | Article |
| id | doaj.art-9631afafa43443bbad1f6c785429acd9 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T06:45:58Z |
| publishDate | 2018-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9631afafa43443bbad1f6c785429acd92022-12-21T23:56:16ZengBMCTrials1745-62152018-04-011911610.1186/s13063-018-2599-2Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trialCatherine M. Legemate0Harold Goei1Esther Middelkoop2Irma M. M. H. Oen3Tim H. J. Nijhuis4Kelly A. A. Kwa5Paul P. M. van Zuijlen6Gerard I. J. M. Beerthuizen7Marianne K. Nieuwenhuis8Margriet E. van Baar9Cornelis H. van der Vlies10Association of Dutch Burn Centers, Maasstad HospitalAssociation of Dutch Burn Centers, Maasstad HospitalDepartment of Plastic, Reconstructive and Hand Surgery, Amsterdam Movement Sciences, VU University Medical CenterBurn Center, Maasstad HospitalDepartment of Plastic, Reconstructive and Hand Surgery, Erasmus Medical CenterBurn Center, Red Cross HospitalDepartment of Plastic, Reconstructive and Hand Surgery, Amsterdam Movement Sciences, VU University Medical CenterBurn Center, Martini HospitalAssociation of Dutch Burn Centers, Martini HospitalAssociation of Dutch Burn Centers, Maasstad HospitalBurn Center, Maasstad HospitalAbstract Background Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the last decade hydrosurgery has become popular as a new tool for tangential excision. Hydrosurgery is generally thought to be a more precise and controlled manner of burn debridement leading to preservation of viable tissue and, therefore, better scar quality. Although scar quality is considered to be one of the most important outcomes in burn surgery today, no randomized controlled study has compared the effect of these two common treatment modalities with scar quality as a primary outcome. The aim of this study is, therefore, to compare long-term scar quality after hydrosurgical versus conventional tangential excision in deep dermal burns. Methods/design A multicenter, randomized, intra-patient, controlled trial will be conducted in the Dutch burn centers of Rotterdam, Beverwijk, and Groningen. All patients with deep dermal burns that require excision and grafting are eligible. Exclusion criteria are: a burn wound < 50 cm2, total body surface area (TBSA) burned > 30%, full-thickness burns, chemical or electrical burns, infected wounds (clinical symptoms in combination with positive wound swabs), insufficient knowledge of the Dutch or English language, patients that are unlikely to comply with requirements of the study protocol and follow-up, and patients who are (temporarily) incompetent because of sedation and/or intubation. A total of 137 patients will be included. Comparable wound areas A and B will be appointed, randomized and either excised conventionally with a knife or with the hydrosurgery system. The primary outcome is scar quality measured by the observer score of the Patient and Observer Scar Assessment Scale (POSAS); a subjective scar-assessment instrument, consisting of two separate six-item scales (observer and patient) that are both scored on a 10-point rating scale. Discussion This study will contribute to the optimal surgical treatment of patients with deep dermal burn wounds. Trial registration Dutch Trial Register, NTR6232. Registered on 23 January 2017.http://link.springer.com/article/10.1186/s13063-018-2599-2Conventional debridementVersajetHydrosurgeryTangential excisionBurnsScar quality |
| spellingShingle | Catherine M. Legemate Harold Goei Esther Middelkoop Irma M. M. H. Oen Tim H. J. Nijhuis Kelly A. A. Kwa Paul P. M. van Zuijlen Gerard I. J. M. Beerthuizen Marianne K. Nieuwenhuis Margriet E. van Baar Cornelis H. van der Vlies Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial Trials Conventional debridement Versajet Hydrosurgery Tangential excision Burns Scar quality |
| title | Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial |
| title_full | Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial |
| title_fullStr | Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial |
| title_full_unstemmed | Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial |
| title_short | Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial |
| title_sort | long term scar quality after hydrosurgical versus conventional debridement of deep dermal burns hycon trial study protocol for a randomized controlled trial |
| topic | Conventional debridement Versajet Hydrosurgery Tangential excision Burns Scar quality |
| url | http://link.springer.com/article/10.1186/s13063-018-2599-2 |
| work_keys_str_mv | AT catherinemlegemate longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT haroldgoei longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT esthermiddelkoop longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT irmammhoen longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT timhjnijhuis longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT kellyaakwa longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT paulpmvanzuijlen longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT gerardijmbeerthuizen longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT marianneknieuwenhuis longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT margrietevanbaar longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial AT cornelishvandervlies longtermscarqualityafterhydrosurgicalversusconventionaldebridementofdeepdermalburnshycontrialstudyprotocolforarandomizedcontrolledtrial |